<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/NCT04448106</url>
  </required_header>
  <id_info>
    <org_study_id>CTX0020-002</org_study_id>
    <nct_id>NCT04448106</nct_id>
  </id_info>
  <brief_title>Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis</brief_title>
  <acronym>AdMSCs</acronym>
  <official_title>Clinical Study for Subjects With Osteoarthritis of Knees, Hips, and Shoulders Using a Combination of Intravenous Infusions With Intra-articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celltex Therapeutics Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celltex Therapeutics Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint&#xD;
      category), randomized control group clinical study with 300 subjects diagnosed with&#xD;
      osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will&#xD;
      be evaluated for disease-associated severity according to symptoms, such as pain, mobility,&#xD;
      daily active life, and functions using arthritis society established specific measurement&#xD;
      tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and&#xD;
      CSS for OA-shoulders).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 25, 2023</start_date>
  <completion_date type="Anticipated">August 15, 2026</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Patients and evaluators</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects.</measure>
    <time_frame>12 months</time_frame>
    <description>safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Any organ damage or safety concerns determined by SMAC 20 blood test.</measure>
    <time_frame>12 months</time_frame>
    <description>Safety</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients</measure>
    <time_frame>12 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients</measure>
    <time_frame>12 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients</measure>
    <time_frame>12 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients</measure>
    <time_frame>12 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients</measure>
    <time_frame>12 month</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients</measure>
    <time_frame>12 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in joint images (X-ray or MRI) from the baseline</measure>
    <time_frame>12 months</time_frame>
    <description>efficacy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline</measure>
    <time_frame>12 months</time_frame>
    <description>efficacy</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline</measure>
    <time_frame>12 months</time_frame>
    <description>efficacy</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Osteoarthritis, Hip</condition>
  <condition>Osteoarthritis Shoulder</condition>
  <arm_group>
    <arm_group_label>Phase 2 Arm 1 - OA Knee</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.&#xD;
On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2 Arm 2 OA Knee</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2 Arm 3 - OA Hip</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.&#xD;
On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2 Arm 4 - OA Hip</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2 Arm 5 - OA Shoulder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.&#xD;
On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2 Arm 6 - OA Shoulder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Celltex- AdMSCs</intervention_name>
    <description>Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue</description>
    <arm_group_label>Phase 2 Arm 1 - OA Knee</arm_group_label>
    <arm_group_label>Phase 2 Arm 2 OA Knee</arm_group_label>
    <arm_group_label>Phase 2 Arm 3 - OA Hip</arm_group_label>
    <arm_group_label>Phase 2 Arm 4 - OA Hip</arm_group_label>
    <arm_group_label>Phase 2 Arm 5 - OA Shoulder</arm_group_label>
    <arm_group_label>Phase 2 Arm 6 - OA Shoulder</arm_group_label>
    <other_name>AdMSCs</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18 years&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Subjects in study group must have banked AdMSCs at Celltex (already passed&#xD;
             communicable disease screen tests for HIV, syphilis and Hepatitis B and C during&#xD;
             banking stage)&#xD;
&#xD;
          -  Must understand and voluntarily sign an Informed Consent for study participation&#xD;
             obtained prior to undergoing any study-specific procedures&#xD;
&#xD;
          -  Must be diagnosed as OA-knees, OA-hips, or OA-shoulders by radiographic criteria and&#xD;
             physical examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another clinical study (with use of another Investigational Medical&#xD;
             Product) within 3 months prior to study treatment start&#xD;
&#xD;
          -  Unwillingness or inability to comply with study procedures&#xD;
&#xD;
          -  Patients with serious basic diseases that affect survival, including blood diseases,&#xD;
             cachexia, active bleeding, severe malnutrition, etc.&#xD;
&#xD;
          -  Clinically active malignant disease&#xD;
&#xD;
          -  Previous thrombotic disorder&#xD;
&#xD;
          -  History of known pulmonary embolism or known secondary anti-phospholipid syndrome&#xD;
&#xD;
          -  Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g.&#xD;
             BSA and sulfur-containing products (e.g., DMSO)&#xD;
&#xD;
          -  Major trauma or surgery within 14 days of study treatment start&#xD;
&#xD;
          -  Mental condition rendering the subject (or the subject's legally acceptable&#xD;
             representative[s]) unable to understand the nature, scope and possible consequences of&#xD;
             the study&#xD;
&#xD;
          -  Alcohol, drug, or medication abuse within one year prior to study treatment start&#xD;
&#xD;
          -  Any condition that, in the Investigator's opinion, is likely to interfere with&#xD;
             evaluation of the AdMSC therapy or satisfactory conduct of the study&#xD;
&#xD;
          -  Irreversible severe end-organ failure, such as heart failure/attack, stroke, liver and&#xD;
             renal failure due to other disease conditions&#xD;
&#xD;
          -  Patients or family history with a hypercoagulable status, such as protein C/protein S&#xD;
             deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.&#xD;
&#xD;
          -  History of long-term use of immunosuppressive agents&#xD;
&#xD;
          -  Organ transplants in the previous 6 months&#xD;
&#xD;
          -  Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth&#xD;
             control during participation in the study duration, unless surgically sterilized or&#xD;
             postmenopausal during the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Derek W Guillory, MD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Root Causes Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jane Young</last_name>
    <phone>7135901000</phone>
    <email>jyoung@celltexbank.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Stanley C Jones</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77098</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Sally McGahee, BS</last_name>
      <phone>713-590-1000</phone>
      <phone_ext>147</phone_ext>
      <email>smcgahee@celltexbank.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autologous Adipose-derived Stem Cells (AdMSCs)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <!-- 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/NCT04448106
org study id: CTX0020-002
nct id: NCT04448106
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint
      category), randomized control group clinical study with 300 subjects diagnosed with
      osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will
      be evaluated for disease-associated severity according to symptoms, such as pain, mobility,
      daily active life, and functions using arthritis society established specific measurement
      tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and
      CSS for OA-shoulders).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The Phase 2 study is an open-label, 6 arms, randomized, control group clinical study conducted in multiple clinical facilities.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Patients and evaluators
measure: the frequency and nature of adverse events occurring during the study based on the annualized rate of all AdMSC-associated adverse events (AEs) in all subjects.
time frame: 12 months
description: safety
measure: Any organ damage or safety concerns determined by SMAC 20 blood test.
time frame: 12 months
description: Safety
measure: Change of Knee injury and Osteoarthritis Outcome Score (KOOS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients
time frame: 12 months
description: efficacy
measure: Change of Knee Society Score (KSS, 0 is the worst and 100 is the best) from the baseline for OA-knee patients
time frame: 12 months
description: efficacy
measure: Change of Hip disability and Osteoarthritis Outcome Score (HOOS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients
time frame: 12 months
description: efficacy
measure: Change of Harris Hip Score (HHS, 0 is the worst and 100 is the best) from the baseline for OA-hip patients
time frame: 12 months
description: efficacy
measure: Change of the American Shoulder and Elbow Surgeons Shoulder Score (ASES, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients
time frame: 12 month
description: efficacy
measure: Change of Constant shoulder score (CSS, 0 is the worst and 100 is the best) from the baseline for OA-shoulder patients
time frame: 12 months
description: efficacy
measure: changes in joint images (X-ray or MRI) from the baseline
time frame: 12 months
description: efficacy
measure: Number of patients achieve visual analog scale (VAS) pain improvement above 30%, 50% and 70% from the baseline
time frame: 12 months
description: efficacy
measure: Number of patient achieve Image (X-ray or MRI) improvement above 30%, 50% and 70% from the baseline
time frame: 12 months
description: efficacy
arm group label: Phase 2 Arm 1 - OA Knee
arm group type: Experimental
description: 50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.
On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.
arm group label: Phase 2 Arm 2 OA Knee
arm group type: Active Comparator
description: Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion
arm group label: Phase 2 Arm 3 - OA Hip
arm group type: Experimental
description: 50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.
On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.
arm group label: Phase 2 Arm 4 - OA Hip
arm group type: Active Comparator
description: Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion
arm group label: Phase 2 Arm 5 - OA Shoulder
arm group type: Experimental
description: 50 subjects receive two doses of 2.0-2.86 x 10^6 cells/kg on days 0 and 6 via intravenous infusion.
On day 3, each subject will receive a single dose of 1.0-2.86 x 10^6 cells/kg via intra-articular injection into the injured joint.
arm group label: Phase 2 Arm 6 - OA Shoulder
arm group type: Active Comparator
description: Control group- 50 subjects receive three doses of 2.0-2.86 x 10^6 cells/kg on day 0, 3, and 6 via intravenous infusion
intervention type: Biological
intervention name: Celltex- AdMSCs
description: Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
arm group label: Phase 2 Arm 1 - OA Knee
arm group label: Phase 2 Arm 2 OA Knee
arm group label: Phase 2 Arm 3 - OA Hip
arm group label: Phase 2 Arm 4 - OA Hip
arm group label: Phase 2 Arm 5 - OA Shoulder
arm group label: Phase 2 Arm 6 - OA Shoulder
other name: AdMSCs
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Derek W Guillory, MD.
role: Principal Investigator
affiliation: Root Causes Medicine
last name: Jane Young
phone: 7135901000
email: jyoung@celltexbank.com
facility: 
contact: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Osteoarthritis, Hip