<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/NCT02993809</url>
  </required_header>
  <id_info>
    <org_study_id>BMEC-PRPE</org_study_id>
    <nct_id>NCT02993809</nct_id>
  </id_info>
  <brief_title>Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>South China Research Center for Stem Cell and Regenerative Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>South China Research Center for Stem Cell and Regenerative Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The intent of this clinical study is to evaluate the safety of the injection composed of&#xD;
      autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract&#xD;
      (PRPE) for the treatment of critical limb ischemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>March 2018</start_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival without major amputation</measure>
    <time_frame>6 months after implantation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)</measure>
    <time_frame>Within 6 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2)</measure>
    <time_frame>Within 6 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perfusion rate in treated tissue by digital subtraction angiography (DSA)</measure>
    <time_frame>Within 6 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>wound size</measure>
    <time_frame>Within 6 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>wound stage</measure>
    <time_frame>Within 6 months after implantation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>Within 6 months after implantation</time_frame>
    <description>Pain intensity using Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thermography</measure>
    <time_frame>Within 6 months after implantation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Leg Ulcer</condition>
  <condition>Diabetic Foot</condition>
  <condition>Gangrene</condition>
  <condition>Peripheral Vascular Disease</condition>
  <condition>Ischemia</condition>
  <arm_group>
    <arm_group_label>BM-ECs and PRPE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multipoint of intramuscular injections into ischemic limbs.Injections composed of bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BM-ECs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intramuscular injection of bone marrow derived endothelial cells only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BM-ECs and PRPE</intervention_name>
    <arm_group_label>BM-ECs and PRPE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BM-ECs</intervention_name>
    <arm_group_label>BM-ECs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Limb ischemia patients(e.g. arteriosclerosis obliterans,diabetic critical limb ischemia,&#xD;
        thromboangitis obliterans)&#xD;
&#xD;
          1. 18 Years to 80 Years (Adult, Senior);&#xD;
&#xD;
          2. Have ability to understand and comply with the study requirements, and provide the&#xD;
             written informed consent prior to any procedures ;&#xD;
&#xD;
          3. Patient meets at least one of the following diagnostic criteria for the index limb:&#xD;
&#xD;
               1. ABI&lt;0.7mmHg&#xD;
&#xD;
               2. TcpO2 &lt;40 mm Hg&#xD;
&#xD;
               3. Or, nonhealing ulcer due to local arterial compromise with no opportunity for&#xD;
                  revascularization;&#xD;
&#xD;
          4. Have no improvement after conservative treatment and are not suitable for surgical&#xD;
             bypass surgery because no outflow tract of diseased vessel can be found by imaging;&#xD;
&#xD;
          5. Despite having good outflow artery, but the elderly and frail patients can also not&#xD;
             tolerate revascularization or interventional surgery;&#xD;
&#xD;
          6. Unlikelihood of major amputation of the leg during the next 12 months;&#xD;
&#xD;
          7. Expected life span more than 2 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating;&#xD;
&#xD;
          2. Diabetics with poorly controlled blood glucose levels (defined as HbA1c&gt;7% and/or&#xD;
             proliferative retinopathy);&#xD;
&#xD;
          3. Patients with decompensated cardiac, renal or liver disease;&#xD;
&#xD;
          4. Patients with confirmed malignant tumor;&#xD;
&#xD;
          5. Subjects are with serious heart, liver, kidney and lung failure or under poor general&#xD;
             condition that are inability to undergo bone marrow harvesting and transplantation;&#xD;
&#xD;
          6. Known or suspected disease of the immune system or osteomyelitis;&#xD;
&#xD;
          7. Inability to sign informed consent form and to comply with the schedule of the study;&#xD;
&#xD;
          8. There has reason to suspect that the patient is forced to join the study;&#xD;
&#xD;
          9. Any other condition, in the opinion of the investigator, would render the patient&#xD;
             unsuitable for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xuetao Pei, M.D., Ph.D</last_name>
    <phone>8610-68164807</phone>
    <email>AMMS0906@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fang Fang, Ph.D</last_name>
    <phone>8620-89199011</phone>
    <email>fangfang@scrm.org.cn</email>
  </overall_contact_backup>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Foot</mesh_term>
    <mesh_term>Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Leg Ulcer</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Gangrene</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02993809
org study id: BMEC-PRPE
nct id: NCT02993809
lead sponsor: 
has dmc: Yes
The intent of this clinical study is to evaluate the safety of the injection composed of
      autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract
      (PRPE) for the treatment of critical limb ischemia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival without major amputation
time frame: 6 months after implantation
measure: Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)
time frame: Within 6 months after implantation
measure: Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2)
time frame: Within 6 months after implantation
measure: Perfusion rate in treated tissue by digital subtraction angiography (DSA)
time frame: Within 6 months after implantation
measure: wound size
time frame: Within 6 months after implantation
measure: wound stage
time frame: Within 6 months after implantation
measure: Pain intensity
time frame: Within 6 months after implantation
description: Pain intensity using Visual Analogue Scale
measure: Thermography
time frame: Within 6 months after implantation
arm group label: BM-ECs and PRPE
arm group type: Experimental
description: Multipoint of intramuscular injections into ischemic limbs.Injections composed of bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE).
arm group label: BM-ECs
arm group type: Active Comparator
description: Intramuscular injection of bone marrow derived endothelial cells only.
intervention type: Biological
intervention name: BM-ECs and PRPE
arm group label: BM-ECs and PRPE
intervention type: Biological
intervention name: BM-ECs
arm group label: BM-ECs
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xuetao Pei, M.D., Ph.D
phone: 8610-68164807
email: AMMS0906@163.com
last name: Fang Fang, Ph.D
phone: 8620-89199011
email: fangfang@scrm.org.cn
responsible party type: Sponsor
mesh term: Diabetic Foot
mesh term: Vascular Diseases
mesh term: Peripheral Vascular Diseases
mesh term: Peripheral Arterial Disease
mesh term: Leg Ulcer
mesh term: Ischemia
mesh term: Gangrene
sharing ipd: Yes