<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03786744</url>
  </required_header>
  <id_info>
    <org_study_id>12112018</org_study_id>
    <nct_id>NCT03786744</nct_id>
  </id_info>
  <brief_title>Allogenic Cord Blood Transfusion in Patients With Autism</brief_title>
  <official_title>Efficiency Evaluation of Allogenic Umbilical Cord Blood (UCB) Transfusion in Patients With Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State-Financed Health Facility &quot;Samara Regional Medical Center Dinasty&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State-Financed Health Facility &quot;Samara Regional Medical Center Dinasty&quot;</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by&#xD;
      social interaction abnormalities, impaired verbal and non-verbal communication, and&#xD;
      repetitive, obsessive behavior, while the therapeutic effect of current treatments remains&#xD;
      limited progress.&#xD;
&#xD;
      The possible reason for ASD is neural hypoperfusion and immune deregulation. The Human&#xD;
      Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to&#xD;
      modulate the immune response and enhance angiogenesis, suggesting the novel and promising&#xD;
      therapeutic strategy. In this study, the safety and efficacy of hUCB-MNCs infusion will be&#xD;
      evaluated in patients with Autism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autism Spectrum Disorders (ASD) are heterogeneous neuro-developed disorders. Autism is the&#xD;
      most common disorder of the diseases characterized by dysfunctions in response social&#xD;
      interaction and communication, as well as the presence of repetitive and stereotyped&#xD;
      behaviors. Recent reports of a sharp increase in the number of children with autism. The&#xD;
      exact etiology of autism remains unclear. Compliance, the definition of effective treatments&#xD;
      for autism is particularly difficult.&#xD;
&#xD;
      Although it has been understood, it can be a question of immune dysregulation. Examination of&#xD;
      the inflammatory cytokines, dysfunction of the immune system and the immune system. The Human&#xD;
      Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to&#xD;
      modulate the immune response and enhance angiogenesis, suggesting the novel and promising&#xD;
      therapeutic strategy. The Our study suggest that infusion of cord blood mononuclear cells&#xD;
      will affect Autism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2018</start_date>
  <completion_date type="Actual">December 12, 2019</completion_date>
  <primary_completion_date type="Actual">October 12, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is prospective, non-randomized (open label) with control group study. The total 20 patient will be enrolled in this study. In 10 patient with ASD will be infused with umbilical corb blood. Other 10 patient with ASD will be treated with standard therapy (control group).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion</measure>
    <time_frame>24hrs post transfusion</time_frame>
    <description>Safety assessment. The adverse events rate will be assessed in all patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Autism Treatment Evaluation Checklist (ATEC).</measure>
    <time_frame>score at baseline, 1, 2, 6, 12 months</time_frame>
    <description>The ATEC is designed to measure changes in the severity of ASD in response to treatment. A total score and 4 subscale scores are reported. Questions in the first 3 subscales are scored using a 0-3 scale (not true/partially true/absolutely true). The 4 subscale, Health/Physical/Behavior, is scored using a 0-4 point scale (Not a problem/Minor problem/Moderate problem/Serious problem). The first subscale, Speech/Language/Communication, contains 14 items where the score ranges from 0-28 points. The Sociability subscale contains 20 items and participants can score from 0-40. The third subscale, Sensory/Cognitive awareness, has 18 items and scores range from 0-36. Finally, the Health/Physical/Behavior subscale contains 25 items and scores range from 0-75. The scores from each subscale are combined in order to calculate a Total Score, which ranges from 0 to179 points. A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cytokine Analysis.</measure>
    <time_frame>score at baseline, 1, 2, 6 months</time_frame>
    <description>IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune Status as Determined by Percentage of Peripheral Blood Cells</measure>
    <time_frame>score at baseline, 6 month</time_frame>
    <description>Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells</measure>
    <time_frame>score at baseline, 6 month</time_frame>
    <description>Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>ASD CB-MNC injection.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ASD CB-MNC injection from different donors and standard therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard therapy.</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients with standard therapy as control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ASD CB-MNC injection.</intervention_name>
    <description>CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.</description>
    <arm_group_label>ASD CB-MNC injection.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard therapy.</intervention_name>
    <description>The standard therapy can include drugs, special psychology training etc.</description>
    <arm_group_label>ASD CB-MNC injection.</arm_group_label>
    <arm_group_label>Standard therapy.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis: autistic type disorder (ASD).&#xD;
&#xD;
          -  Systemic speech underdevelopment&#xD;
&#xD;
          -  The presence of attention deficit hyperactivity disorder as a comorbid state&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  organic pathology of the brain according to CT, MRI&#xD;
&#xD;
          -  the presence of the following diseases in history: heart failure in the stage of&#xD;
             decompensation, stroke in history less than 1 year ago, blood diseases;&#xD;
&#xD;
          -  decompensation of chronic and endocrinological diseases;&#xD;
&#xD;
          -  acute respiratory viral and bacterial infections, period less than 1 month after the&#xD;
             acute phase.&#xD;
&#xD;
          -  HIV infection, hepatitis B and C.&#xD;
&#xD;
          -  oncological diseases, chemotherapy in the anamnesis;&#xD;
&#xD;
          -  tuberculosis.&#xD;
&#xD;
          -  Severe form of intellectual disability.&#xD;
&#xD;
          -  Cerebral palsy.&#xD;
&#xD;
          -  epilepsy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>STANISLAV VOLCHKOV, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Centre Dinasty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Centre Dinasty</name>
      <address>
        <city>Samara</city>
        <zip>443095</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <results_first_submitted>July 22, 2020</results_first_submitted>
  <results_first_submitted_qc>October 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 19, 2020</results_first_posted>
  <last_update_submitted>October 28, 2020</last_update_submitted>
  <last_update_submitted_qc>October 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State-Financed Health Facility &quot;Samara Regional Medical Center Dinasty&quot;</investigator_affiliation>
    <investigator_full_name>Volchkov Stanislav</investigator_full_name>
    <investigator_title>Deputy director, Quality assurance director</investigator_title>
  </responsible_party>
  <keyword>Autism, ASD, Cord blood</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03786744/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ASD CB-MNC Injection.</title>
          <description>ASD CB-MNC injection from different donors and standard therapy.&#xD;
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
        </group>
        <group group_id="P2">
          <title>Standard Therapy.</title>
          <description>Patients with standard therapy as control group.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ASD CB-MNC Injection.</title>
          <description>ASD CB-MNC injection from different donors and standard therapy.&#xD;
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
        </group>
        <group group_id="B2">
          <title>Standard Therapy.</title>
          <description>Patients with standard therapy as control group.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.95" lower_limit="4.5" upper_limit="14"/>
                    <measurement group_id="B2" value="7.80" lower_limit="4.3" upper_limit="13"/>
                    <measurement group_id="B3" value="7.87" lower_limit="4.3" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Russia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="10"/>
                    <count group_id="B2" value="10"/>
                    <count group_id="B3" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion</title>
        <description>Safety assessment. The adverse events rate will be assessed in all patients.</description>
        <time_frame>24hrs post transfusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ASD CB-MNC Injection.</title>
            <description>ASD CB-MNC injection from different donors and standard therapy.&#xD;
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>The standard therapy can include drugs, special psychology training etc.</description>
          </group>
        </group_list>
        <measure>
          <title>A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion</title>
          <description>Safety assessment. The adverse events rate will be assessed in all patients.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Increase in body temperature</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chill</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypotension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Skin itching</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hives</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-transfusion purple</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oedema Quinque</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oliguria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematuria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Jaundice</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dizziness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at injection site</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anxiety</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Autism Treatment Evaluation Checklist (ATEC).</title>
        <description>The ATEC is designed to measure changes in the severity of ASD in response to treatment. A total score and 4 subscale scores are reported. Questions in the first 3 subscales are scored using a 0-3 scale (not true/partially true/absolutely true). The 4 subscale, Health/Physical/Behavior, is scored using a 0-4 point scale (Not a problem/Minor problem/Moderate problem/Serious problem). The first subscale, Speech/Language/Communication, contains 14 items where the score ranges from 0-28 points. The Sociability subscale contains 20 items and participants can score from 0-40. The third subscale, Sensory/Cognitive awareness, has 18 items and scores range from 0-36. Finally, the Health/Physical/Behavior subscale contains 25 items and scores range from 0-75. The scores from each subscale are combined in order to calculate a Total Score, which ranges from 0 to179 points. A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD.</description>
        <time_frame>score at baseline, 1, 2, 6, 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ASD CB-MNC Injection.</title>
            <description>ASD CB-MNC injection from different donors and standard therapy.&#xD;
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
          </group>
          <group group_id="O2">
            <title>Standard Therapy.</title>
            <description>The standard therapy can include drugs, special psychology training etc.</description>
          </group>
        </group_list>
        <measure>
          <title>Autism Treatment Evaluation Checklist (ATEC).</title>
          <description>The ATEC is designed to measure changes in the severity of ASD in response to treatment. A total score and 4 subscale scores are reported. Questions in the first 3 subscales are scored using a 0-3 scale (not true/partially true/absolutely true). The 4 subscale, Health/Physical/Behavior, is scored using a 0-4 point scale (Not a problem/Minor problem/Moderate problem/Serious problem). The first subscale, Speech/Language/Communication, contains 14 items where the score ranges from 0-28 points. The Sociability subscale contains 20 items and participants can score from 0-40. The third subscale, Sensory/Cognitive awareness, has 18 items and scores range from 0-36. Finally, the Health/Physical/Behavior subscale contains 25 items and scores range from 0-75. The scores from each subscale are combined in order to calculate a Total Score, which ranges from 0 to179 points. A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Speech/Language/Communication at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="10" upper_limit="20"/>
                    <measurement group_id="O2" value="14" lower_limit="13" upper_limit="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Speech/Language/Communication at 1 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="5" upper_limit="18"/>
                    <measurement group_id="O2" value="14" lower_limit="11" upper_limit="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Speech/Language/Communication at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="2" upper_limit="17"/>
                    <measurement group_id="O2" value="16" lower_limit="14" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Speech/Language/Communication at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="5" upper_limit="22"/>
                    <measurement group_id="O2" value="14" lower_limit="12" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Speech/Language/Communication at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="6" upper_limit="17"/>
                    <measurement group_id="O2" value="15" lower_limit="13" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sociability at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="9" upper_limit="17"/>
                    <measurement group_id="O2" value="11" lower_limit="9" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sociability at 1 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="9" upper_limit="13"/>
                    <measurement group_id="O2" value="12" lower_limit="9" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sociability at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="6" upper_limit="14"/>
                    <measurement group_id="O2" value="11" lower_limit="10" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sociability at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="8" upper_limit="14"/>
                    <measurement group_id="O2" value="13" lower_limit="10" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sociability at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="8" upper_limit="14"/>
                    <measurement group_id="O2" value="14" lower_limit="11" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory/Cognitive Awareness at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="9" upper_limit="14"/>
                    <measurement group_id="O2" value="12" lower_limit="10" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory/Cognitive Awareness at 1 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="6" upper_limit="15"/>
                    <measurement group_id="O2" value="11" lower_limit="10" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory/Cognitive Awareness at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="5" upper_limit="11"/>
                    <measurement group_id="O2" value="11" lower_limit="11" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory/Cognitive Awareness at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="8" upper_limit="14"/>
                    <measurement group_id="O2" value="14" lower_limit="11" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensory/Cognitive Awareness at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="7" upper_limit="13"/>
                    <measurement group_id="O2" value="13" lower_limit="11" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health/ Physical Development/Behaviour at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" lower_limit="19" upper_limit="30"/>
                    <measurement group_id="O2" value="24" lower_limit="19" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health/ Physical Development/Behaviour at 1 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="13" upper_limit="21"/>
                    <measurement group_id="O2" value="24" lower_limit="19" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health/ Physical Development/Behaviour at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="7" upper_limit="18"/>
                    <measurement group_id="O2" value="23" lower_limit="19" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health/ Physical Development/Behaviour at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="13" upper_limit="25"/>
                    <measurement group_id="O2" value="24" lower_limit="19" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Health/ Physical Development/Behaviour at 12months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="10" upper_limit="17"/>
                    <measurement group_id="O2" value="22" lower_limit="19" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" lower_limit="56" upper_limit="66"/>
                    <measurement group_id="O2" value="62" lower_limit="59" upper_limit="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score at 1 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" lower_limit="43" upper_limit="60"/>
                    <measurement group_id="O2" value="65" lower_limit="60" upper_limit="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44" lower_limit="31" upper_limit="57"/>
                    <measurement group_id="O2" value="68" lower_limit="59" upper_limit="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" lower_limit="49" upper_limit="65"/>
                    <measurement group_id="O2" value="70" lower_limit="60" upper_limit="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" lower_limit="38" upper_limit="61"/>
                    <measurement group_id="O2" value="71" lower_limit="60" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.049367</p_value>
            <p_value_desc>Alternative hypothesis: can be changed of speech, language, communication skills for Cord Blood versus Placebo groups in 2-month Threshold &lt;0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>9</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004072</p_value>
            <p_value_desc>Alternative hypothesis: can be changed average of 2-month of Health/Physical Development/Behaviour for Cord Blood versus Control groups.&#xD;
Threshold &lt;0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Median Difference (Net)</param_type>
            <param_value>9</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0 and MS Office Excel 2007. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.017258</p_value>
            <p_value_desc>Alternative hypothesis: can be changed average of 12-month of Health/Physical Development/Behaviour for Cord Blood versus Placebo groups.&#xD;
Threshold &lt;0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>9</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.031210</p_value>
            <p_value_desc>Alternative hypothesis: can be changed average of 1-month of total score for Cord Blood versus Placebo groups.&#xD;
Threshold &lt;0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>10</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001940</p_value>
            <p_value_desc>Alternative hypothesis: can be changed average of 2-month of Total score for Cord Blood versus Placebo groups.&#xD;
Threshold &lt;0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>24</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.031210</p_value>
            <p_value_desc>Alternative hypothesis: can be changed average of 6-month of Total score for Cord Blood versus Placebo groups.&#xD;
Threshold &lt;0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>15</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The study results were statistically processed using parametric and non-parametric methods using STATA version 9.0, Statistica for Windows version 6.0. Changes from the beginning of therapy and after 1, 2, 6, 12 months were compared using the Wilcoxon criterion, data between the main group and the control group were compared using non-parametric method, Mann-Whitney test was used (data are presented in Me - median format with an indication of 25% and 75% quartile</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011330</p_value>
            <p_value_desc>Alternative hypothesis: can be changed average of 12-month of Total score for Cord Blood versus Placebo groups.&#xD;
Threshold &lt;0.05</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>16</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cytokine Analysis.</title>
        <description>IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood</description>
        <time_frame>score at baseline, 1, 2, 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ASD CB-MNC Injection.</title>
            <description>ASD CB-MNC injection from different donors and standard therapy.&#xD;
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
          </group>
        </group_list>
        <measure>
          <title>Cytokine Analysis.</title>
          <description>IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood</description>
          <units>pg/mL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>y-IFN pg/ml at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>y-IFN pg/ml at 1 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>y-IFN pg/ml at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>y-IFN pg/ml at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL1b pg/ml at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.228" lower_limit="0" upper_limit="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL1b pg/ml at 1 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.279" lower_limit="0" upper_limit="3.117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL1b pg/ml at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9675" lower_limit="0.095" upper_limit="3.251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL1b pg/ml at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.794" lower_limit="0.396" upper_limit="3.103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL6 pg/ml at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0225" lower_limit="0.43" upper_limit="2.168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL6 pg/ml at 1 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.673" lower_limit="0.392" upper_limit="2.076"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL6 pg/ml at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5625" lower_limit="0.195" upper_limit="0.753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL6pg/ml at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7455" lower_limit="0.494" upper_limit="0.863"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL8 pg/ml at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9175" lower_limit="1.913" upper_limit="9.822"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL8 pg/ml at 1 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7985" lower_limit="2.157" upper_limit="5.341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL8 pg/ml at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7485" lower_limit="1.197" upper_limit="3.348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IL8 pg/ml at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7975" lower_limit="3.507" upper_limit="38.388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha pg/ml at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha pg/ml at 1 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha pg/ml at 2 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TNF-alpha pg/ml at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immune Status as Determined by Percentage of Peripheral Blood Cells</title>
        <description>Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%)</description>
        <time_frame>score at baseline, 6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ASD CB-MNC Injection.</title>
            <description>ASD CB-MNC injection from different donors and standard therapy.&#xD;
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
          </group>
        </group_list>
        <measure>
          <title>Immune Status as Determined by Percentage of Peripheral Blood Cells</title>
          <description>Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%)</description>
          <units>percentage of cells</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD 3+(%) at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.24" lower_limit="58.55" upper_limit="66.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD 3+(%) at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.71" lower_limit="58.56" upper_limit="67.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD3+СD8+ (%) at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.33" lower_limit="22.36" upper_limit="25.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD3+СD8+(%) at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.345" lower_limit="20.19" upper_limit="26.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD3+СD4+ (%) at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.835" lower_limit="29.14" upper_limit="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD3+СD4+(%) at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.55" lower_limit="30.26" upper_limit="35.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD3+СD4+СD8+ (%) at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.215" lower_limit="0.19" upper_limit="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD3+СD4+СD8+(%) at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" lower_limit="0.25" upper_limit="0.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD16+СD56+(%) at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.19" lower_limit="7.29" upper_limit="21.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD16+СD56+(%) at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.05" lower_limit="11.47" upper_limit="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD19+(%) at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.29" lower_limit="17.46" upper_limit="21.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD19+ (%) at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.255" lower_limit="16.25" upper_limit="18.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells</title>
        <description>Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.)</description>
        <time_frame>score at baseline, 6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ASD CB-MNC Injection.</title>
            <description>ASD CB-MNC injection from different donors and standard therapy.&#xD;
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
          </group>
        </group_list>
        <measure>
          <title>Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells</title>
          <description>Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.)</description>
          <units>cells/µl</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CD 3+ at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1450.355" lower_limit="1364.77" upper_limit="2163.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD 3+at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1829.11" lower_limit="1507.34" upper_limit="2312.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD 3+CD8+ at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="598.48" lower_limit="481.48" upper_limit="790.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD 3+CD8+ at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="654.385" lower_limit="600.56" upper_limit="819.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD 3+CD4+ at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="750.08" lower_limit="649.35" upper_limit="1197.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD 3+CD4+ at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="877.095" lower_limit="752.35" upper_limit="1197.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD 3+ CD4+CD8+ at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.555" lower_limit="3.59" upper_limit="7.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD 3+ CD4+CD8+ at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.656" lower_limit="7.46" upper_limit="10.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD 16+CD56+ at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="321.89" lower_limit="188.46" upper_limit="550.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CD 16+CD56+ at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="476.055" lower_limit="306.37" upper_limit="607.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD19+ at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="457.505" lower_limit="431.81" upper_limit="839.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>СD19+ at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506.365" lower_limit="392.8" upper_limit="650.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ASD CB-MNC Injection.</title>
          <description>ASD CB-MNC injection from different donors and standard therapy.&#xD;
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
        </group>
        <group group_id="E2">
          <title>Standard Therapy.</title>
          <description>Patients with standard therapy as control group.&#xD;
Standard therapy.: The standard therapy can include drugs, special psychology training etc.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Infectious nature</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Non Infectious nature</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Infectious nature</sub_title>
                <description>food toxicology</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NON Infectious nature</sub_title>
                <description>Gastritis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <description>seasonal allergy</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Infectious nature</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NON Infectious nature</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Infectious nature</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NON Infectious nature</sub_title>
                <description>head pain, dizziness</description>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric symptoms</sub_title>
                <description>aggression irritability anxiety</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Infectious nature</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NON Infectious nature</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Infectious nature</sub_title>
                <description>3 cases of influenza&#xD;
case laryngitis&#xD;
case tracheobronchitis</description>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NON Infectious nature</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Infectious nature</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>NON Infectious nature</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Volchkov Stanislav</name_or_title>
      <organization>Samara Medical Center Dinasty</organization>
      <phone>+78469564455</phone>
      <email>quality@cordbank.ru</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03786744
org study id: 12112018
nct id: NCT03786744
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by
      social interaction abnormalities, impaired verbal and non-verbal communication, and
      repetitive, obsessive behavior, while the therapeutic effect of current treatments remains
      limited progress.

      The possible reason for ASD is neural hypoperfusion and immune deregulation. The Human
      Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to
      modulate the immune response and enhance angiogenesis, suggesting the novel and promising
      therapeutic strategy. In this study, the safety and efficacy of hUCB-MNCs infusion will be
      evaluated in patients with Autism.
Autism Spectrum Disorders (ASD) are heterogeneous neuro-developed disorders. Autism is the
      most common disorder of the diseases characterized by dysfunctions in response social
      interaction and communication, as well as the presence of repetitive and stereotyped
      behaviors. Recent reports of a sharp increase in the number of children with autism. The
      exact etiology of autism remains unclear. Compliance, the definition of effective treatments
      for autism is particularly difficult.

      Although it has been understood, it can be a question of immune dysregulation. Examination of
      the inflammatory cytokines, dysfunction of the immune system and the immune system. The Human
      Umbilical Cord Blood Mononuclear Cells (hUCB-MNCs) have been shown to have the ability to
      modulate the immune response and enhance angiogenesis, suggesting the novel and promising
      therapeutic strategy. The Our study suggest that infusion of cord blood mononuclear cells
      will affect Autism.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is prospective, non-randomized (open label) with control group study. The total 20 patient will be enrolled in this study. In 10 patient with ASD will be infused with umbilical corb blood. Other 10 patient with ASD will be treated with standard therapy (control group).
primary purpose: Treatment
masking: None (Open Label)
measure: A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
time frame: 24hrs post transfusion
description: Safety assessment. The adverse events rate will be assessed in all patients.
measure: Autism Treatment Evaluation Checklist (ATEC).
time frame: score at baseline, 1, 2, 6, 12 months
description: The ATEC is designed to measure changes in the severity of ASD in response to treatment. A total score and 4 subscale scores are reported. Questions in the first 3 subscales are scored using a 0-3 scale (not true/partially true/absolutely true). The 4 subscale, Health/Physical/Behavior, is scored using a 0-4 point scale (Not a problem/Minor problem/Moderate problem/Serious problem). The first subscale, Speech/Language/Communication, contains 14 items where the score ranges from 0-28 points. The Sociability subscale contains 20 items and participants can score from 0-40. The third subscale, Sensory/Cognitive awareness, has 18 items and scores range from 0-36. Finally, the Health/Physical/Behavior subscale contains 25 items and scores range from 0-75. The scores from each subscale are combined in order to calculate a Total Score, which ranges from 0 to179 points. A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD.
measure: Cytokine Analysis.
time frame: score at baseline, 1, 2, 6 months
description: IL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood
measure: Immune Status as Determined by Percentage of Peripheral Blood Cells
time frame: score at baseline, 6 month
description: Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%)
measure: Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
time frame: score at baseline, 6 month
description: Peripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.)
arm group label: ASD CB-MNC injection.
arm group type: Experimental
description: ASD CB-MNC injection from different donors and standard therapy.
arm group label: Standard therapy.
arm group type: Other
description: Patients with standard therapy as control group.
intervention type: Biological
intervention name: ASD CB-MNC injection.
description: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
arm group label: ASD CB-MNC injection.
intervention type: Other
intervention name: Standard therapy.
description: The standard therapy can include drugs, special psychology training etc.
arm group label: ASD CB-MNC injection.
arm group label: Standard therapy.
criteria: 
gender: All
minimum age: 3 Years
maximum age: 15 Years
healthy volunteers: No
last name: STANISLAV VOLCHKOV, MD, PhD
role: Principal Investigator
affiliation: Medical Centre Dinasty
facility: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: State-Financed Health Facility "Samara Regional Medical Center Dinasty"
investigator full name: Volchkov Stanislav
investigator title: Deputy director, Quality assurance director
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 