<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/NCT03752827</url>
  </required_header>
  <id_info>
    <org_study_id>RC-002</org_study_id>
    <nct_id>NCT03752827</nct_id>
  </id_info>
  <brief_title>Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears</brief_title>
  <official_title>A Prospective, Double-Blinded, Multi-Center Pivotal Trial of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InGeneron, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InGeneron, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this investigation is to evaluate the safety and superior effectiveness in&#xD;
      functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after&#xD;
      the administration of a single injection of adipose-derived regenerative cells (ADRCs) into&#xD;
      the partial-thickness rotator cuff tear compared to the administration of a single&#xD;
      corticosteroid injection into the associated subacromial space.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, double-blinded, randomized, active-controlled, multi-site, pivotal&#xD;
      safety and superior effectiveness study in patients with symptomatic partial-thickness&#xD;
      rotator cuff tears comparing a single ADRC injection generated with the Transpose® RT system&#xD;
      into the supraspinatus tendon and surrounding area to standard-of-care (SOC) corticosteroid&#xD;
      injection into the subacromial bursa.&#xD;
&#xD;
      Up to 20 U.S. centers will be initiated to enroll in the study. 246 subjects assigned to two&#xD;
      randomization arms will be enrolled: an adipose-derived regenerative cell (ADRC) injection&#xD;
      arm (ADRC treatment arm) and the SOC corticosteroid injection arm (active control arm). All&#xD;
      subjects will be randomly assigned to ADRC treatment or active control arms in a 2:1 ratio.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 13, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>It is a double-blinded trial in which the subject, post-procedural investigator and imaging core laboratory radiologists are blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in Pain: VAS</measure>
    <time_frame>24 weeks</time_frame>
    <description>≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Improvement or no worsening in supraspinatus strength</measure>
    <time_frame>24 weeks</time_frame>
    <description>supraspinatus strength on the MRC Muscle Scale compared to baseline For supraspinatus strength on the MRC Muscle Scale compared to baseline&#xD;
• For subjects with normal supraspinatus strength (MRC Muscle Scale = 5] at baseline: no worsening in supraspinatus strength on the MRC Muscle Scale compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS</measure>
    <time_frame>24 weeks</time_frame>
    <description>Pain score compared to baseline at 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale</measure>
    <time_frame>24 weeks</time_frame>
    <description>Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean improvement in VAS - Pain score</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>VAS pain score compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean improvement in WORC score</measure>
    <time_frame>12 and 24 weeks</time_frame>
    <description>WORC score compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale</measure>
    <time_frame>24 weeks</time_frame>
    <description>Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mean improvement in Rand Short Form-36 score</measure>
    <time_frame>24 weeks</time_frame>
    <description>Rand Form-36 score compared at baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Measurement of subject satisfaction with treatment on a VAS scale (VAS - Satisfaction)</measure>
    <time_frame>24 weeks</time_frame>
    <description>VAS satisfaction score improvement</description>
  </other_outcome>
  <other_outcome>
    <measure>Measurement of EuroQoL-5D-5L (EQ-5D-5L)</measure>
    <time_frame>24 weeks</time_frame>
    <description>EuroQoL -5D-5L score</description>
  </other_outcome>
  <other_outcome>
    <measure>Measurement of Shoulder Activity Level</measure>
    <time_frame>24 weeks</time_frame>
    <description>Recording shoulder activity level</description>
  </other_outcome>
  <other_outcome>
    <measure>Measurement of shoulder motion (forward elevation, shoulder abduction in the plane of the scapula)</measure>
    <time_frame>24 weeks</time_frame>
    <description>As determined by goniometer</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">246</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <condition>Rotator Cuff Tendinitis</condition>
  <arm_group>
    <arm_group_label>Adipose Derived Regenerative Cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Corticosteroid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adipose Derived Regenerative Cells</intervention_name>
    <description>Adipose-derived regenerative cells isolated with the Transpose Ultra system</description>
    <arm_group_label>Adipose Derived Regenerative Cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroid</intervention_name>
    <description>Corticosteroid injection into subacrominal space</description>
    <arm_group_label>Corticosteroid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females 30-75 years of age (inclusive).&#xD;
&#xD;
          2. Subjects have a minimum of three (3) months of clinical symptoms consistent with a&#xD;
             partial-thickness rotator cuff tear including but not limited to pain, muscle&#xD;
             weakness, or limited active range of motion (AROM).&#xD;
&#xD;
          3. Subjects have &gt; 70% passive range of motion (PROM) of the index shoulder.&#xD;
&#xD;
          4. Subjects have a baseline VAS - Pain score of ≥ 30 mm.&#xD;
&#xD;
          5. Subjects have a partial-thickness rotator cuff tear, defined as ≥25% partial-thickness&#xD;
             tear of the supraspinatus tendon on a 1.5 Tesla (1.5T) or a 3 Tesla (3T) MRI within&#xD;
             the last 3 months, as determined by the Investigator.&#xD;
&#xD;
          6. Subjects can give appropriate consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt; 30 or &gt; 75.&#xD;
&#xD;
          2. Subject has an insufficient amount of subcutaneous tissue to allow recovery of 100&#xD;
             milliliters (mL) of adipose tissue.&#xD;
&#xD;
          3. Subjects who have received a corticosteroid injection in the index subacromial bursa&#xD;
             within the last 3 months.&#xD;
&#xD;
          4. Subjects who have received more than one (1) previous corticosteroid injections or any&#xD;
             biologic treatment in the index subacromial bursa within the past 6 months.&#xD;
&#xD;
          5. Subjects with severe arthrosis of the glenohumeral or acromioclavicular joint.&#xD;
&#xD;
          6. Subjects with a full-thickness tear of the rotator cuff.&#xD;
&#xD;
          7. Subjects who have undergone major surgery on the affected shoulder meeting one of the&#xD;
             following criteria:&#xD;
&#xD;
               -  Performed as treatment for (or required manipulation of) the rotator cuff.&#xD;
                  Examples include, but are not limited to, subacromial decompression, rotator cuff&#xD;
                  repair, SLAP repair, arthroplasty and fracture fixation with implants that&#xD;
                  involve or penetrate the rotator cuff; OR&#xD;
&#xD;
               -  Performed using implants that interfere with MR visualization and/or evaluation&#xD;
                  of the supraspinatus tendon (e.g., biceps tenodesis); OR&#xD;
&#xD;
               -  Performed in/on the glenohumeral joint, subacromial space, or acromioclavicular&#xD;
                  joint within the last 3 years (e.g. soft tissue Bankart repairs performed &gt;3&#xD;
                  years ago may still qualify).&#xD;
&#xD;
             NOTE: This exclusion criterion does not apply to minor soft tissue procedures with&#xD;
             short recovery periods that do not involve musculoskeletal structures (e.g., lipoma&#xD;
             excision).&#xD;
&#xD;
          8. Subjects who were diagnosed with or treated for adhesive capsulitis of the index&#xD;
             shoulder within the last 5 years.&#xD;
&#xD;
          9. Subjects with current cervical radiculopathy impacting the index shoulder.&#xD;
&#xD;
         10. Subjects who require the use of index arm for ambulation or mobilization via&#xD;
             wheelchair, walker, crutches or cane.&#xD;
&#xD;
         11. Subjects with any contraindication to MRI scan according to MRI guidelines, or who are&#xD;
             unwilling to undergo MRI procedures.&#xD;
&#xD;
         12. Subjects whose pain behavior or pain medication usage is, in the opinion of the&#xD;
             Investigator, out of proportion to the underlying clinical condition or could&#xD;
             interfere with the study- required assessments.&#xD;
&#xD;
         13. Subjects with a history of systemic malignant neoplasms within the last 5 years.&#xD;
&#xD;
         14. Subjects with biopsy-proven, malignant or local neoplasm within the last 6 months or&#xD;
             any history of local neoplasm at the site of administration (on the affected arm),&#xD;
             excluding basal cell carcinoma.&#xD;
&#xD;
         15. Subject is receiving immunosuppressant therapy or has a known immunologic or severe&#xD;
             autoimmune disease that requires chronic systemic immunosuppressive or&#xD;
             immunomodulatory therapy (e.g., human immunodeficiency virus, systemic lupus&#xD;
             erythematosus, rheumatoid arthritis, etc.). [Note: Topical or inhaled corticosteroids&#xD;
             are permitted.]&#xD;
&#xD;
         16. Subject is on an active regimen of chemotherapy or radiation- based treatment.&#xD;
&#xD;
         17. Subjects with an allergy to sodium citrate or any &quot;caine&quot; type of local anesthetic.&#xD;
&#xD;
         18. Subject is pregnant or breastfeeding or plans to become pregnant in the next 12&#xD;
             months.&#xD;
&#xD;
         19. Subjects with clinically significant abnormal Lab tests (i.e. basic metabolic panel&#xD;
             (BMP) or equivalent (e.g. CHEM-7), complete blood count (CBC), Liver function tests&#xD;
             (LFTs), and prothrombin time/international normalized ratio (PT/INR)) as interpreted&#xD;
             by the Investigator.&#xD;
&#xD;
        21. Subjects with a history of a bleeding diathesis or coagulopathy&#xD;
&#xD;
        22. Subject is, in the opinion of the Investigator, unable to comply with the requirements&#xD;
        of the study protocol or is unsuitable for the study for any reason. Examples include the&#xD;
        inability of the subject to complete patient-reported outcome instruments (PROs) and the&#xD;
        inability of the Investigator to perform the injection procedure properly because of&#xD;
        anatomic limitations of the subject.&#xD;
&#xD;
        23. Subject is currently participating in another clinical trial that has not yet completed&#xD;
        its primary endpoint. (Noninterventional observational studies are not exclusionary.)&#xD;
&#xD;
        24. Subject 1) is a litigant in a civil suit that could affect the subject's ability to&#xD;
        complete the study related activities or 2) is a defendant in a criminal case or 3) has an&#xD;
        active workman's compensation case in progress.&#xD;
&#xD;
        25. Subject is part of a vulnerable population who, in the judgment of the Investigator, is&#xD;
        unable to give informed consent for reasons of incapacity, immaturity, adverse personal.&#xD;
        circumstances or lack of autonomy. This may include: individuals with a mental disability,&#xD;
        persons in nursing homes, children, impoverished persons, persons in emergency situations,&#xD;
        homeless persons, nomads, refugees, and those incapable of giving informed consent.&#xD;
        Vulnerable populations also may include members of a group with a hierarchical structure&#xD;
        such as university students, subordinate hospital and laboratory personnel, employees of&#xD;
        the Sponsor, members of the armed forces, and persons kept in detention.&#xD;
&#xD;
        26. Uncooperative subjects or those with neurological/psychiatric disorders who are&#xD;
        incapable of following directions or who are predictably unwilling to return for follow-up&#xD;
        examinations.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biosolutions Clinical Research Center</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lotus Clinical Research, LLC</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sports and Orthopedic Center</name>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <zip>33067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universal Axon Clinical Research</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shrock Clinical Research</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Andrews Institute for Orthopaedics and Sports Medicine</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Institute for Clinical Research</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University School of Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Medical Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Orthopedic Clinic/Research</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HD Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Plastic Surgery</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rotator cuff tear</keyword>
  <keyword>adipose-derived regenerative cells</keyword>
  <keyword>adipose-derived stem cells</keyword>
  <keyword>partial rotator cuff tears</keyword>
  <keyword>corticosteroid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03752827
org study id: RC-002
nct id: NCT03752827
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this investigation is to evaluate the safety and superior effectiveness in
      functional improvement in patients with partial-thickness rotator cuff tears (PTRCTs) after
      the administration of a single injection of adipose-derived regenerative cells (ADRCs) into
      the partial-thickness rotator cuff tear compared to the administration of a single
      corticosteroid injection into the associated subacromial space.
This is a prospective, double-blinded, randomized, active-controlled, multi-site, pivotal
      safety and superior effectiveness study in patients with symptomatic partial-thickness
      rotator cuff tears comparing a single ADRC injection generated with the Transpose® RT system
      into the supraspinatus tendon and surrounding area to standard-of-care (SOC) corticosteroid
      injection into the subacromial bursa.

      Up to 20 U.S. centers will be initiated to enroll in the study. 246 subjects assigned to two
      randomization arms will be enrolled: an adipose-derived regenerative cell (ADRC) injection
      arm (ADRC treatment arm) and the SOC corticosteroid injection arm (active control arm). All
      subjects will be randomly assigned to ADRC treatment or active control arms in a 2:1 ratio.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: It is a double-blinded trial in which the subject, post-procedural investigator and imaging core laboratory radiologists are blinded.
measure: Improvement in Pain: VAS
time frame: 24 weeks
description: ≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)
measure: Improvement or no worsening in supraspinatus strength
time frame: 24 weeks
description: supraspinatus strength on the MRC Muscle Scale compared to baseline For supraspinatus strength on the MRC Muscle Scale compared to baseline
• For subjects with normal supraspinatus strength (MRC Muscle Scale = 5] at baseline: no worsening in supraspinatus strength on the MRC Muscle Scale compared to baseline
measure: Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS
time frame: 24 weeks
description: Pain score compared to baseline at 24 weeks
measure: Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale
time frame: 24 weeks
description: Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks
measure: Mean improvement in VAS - Pain score
time frame: 12 and 24 weeks
description: VAS pain score compared to baseline
measure: Mean improvement in WORC score
time frame: 12 and 24 weeks
description: WORC score compared to baseline
measure: Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale
time frame: 24 weeks
description: Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks.
measure: Mean improvement in Rand Short Form-36 score
time frame: 24 weeks
description: Rand Form-36 score compared at baseline
measure: Measurement of subject satisfaction with treatment on a VAS scale (VAS - Satisfaction)
time frame: 24 weeks
description: VAS satisfaction score improvement
measure: Measurement of EuroQoL-5D-5L (EQ-5D-5L)
time frame: 24 weeks
description: EuroQoL -5D-5L score
measure: Measurement of Shoulder Activity Level
time frame: 24 weeks
description: Recording shoulder activity level
measure: Measurement of shoulder motion (forward elevation, shoulder abduction in the plane of the scapula)
time frame: 24 weeks
description: As determined by goniometer
arm group label: Adipose Derived Regenerative Cells
arm group type: Experimental
description: Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear
arm group label: Corticosteroid
arm group type: Active Comparator
description: Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance.
intervention type: Device
intervention name: Adipose Derived Regenerative Cells
description: Adipose-derived regenerative cells isolated with the Transpose Ultra system
arm group label: Adipose Derived Regenerative Cells
intervention type: Drug
intervention name: Corticosteroid
description: Corticosteroid injection into subacrominal space
arm group label: Corticosteroid
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tendinopathy
mesh term: Rotator Cuff Injuries
sharing ipd: No