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Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03752827
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
InGeneron, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Rotator Cuff Tendinitis Device: Adipose Derived Regenerative Cells Drug: Corticosteroid Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
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
Actual Study Start Date : May 13, 2019
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids Tears

Arm Intervention/treatment
Experimental: Adipose Derived Regenerative Cells
Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear
Device: Adipose Derived Regenerative Cells
Adipose-derived regenerative cells isolated with the Transpose Ultra system

Active Comparator: Corticosteroid
Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance.
Drug: Corticosteroid
Corticosteroid injection into subacrominal space




Primary Outcome Measures :
  1. Improvement in Pain: VAS [ Time Frame: 48 weeks ]
    ≥ 14-millimeter (mm) improvement in Visual Analog Scale (VAS)

  2. Improvement or no worsening in supraspinatus strength [ Time Frame: 48 weeks ]

    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



Secondary Outcome Measures :
  1. Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS [ Time Frame: 24 weeks ]
    Pain score compared to baseline at 24 weeks

  2. Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale [ Time Frame: 24 weeks ]
    Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks

  3. Mean improvement in VAS - Pain score [ Time Frame: 48 weeks ]
    VAS pain score compared to baseline

  4. Mean improvement in WORC score [ Time Frame: 24 weeks ]
    WORC score compared to baseline

  5. Percentage of subjects who demonstrate an improvement in MRI-assessed supraspinatus tendon tear status [ Time Frame: 24 weeks ]
    Percentage of subjects with improvement

  6. Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale [ Time Frame: 24 weeks ]
    Supraspinatus strength on the MRC Muscle Scale compared to baseline at 24 weeks.


Other Outcome Measures:
  1. Mean improvement in Rand Short Form-36 score [ Time Frame: 48 weeks ]
    Rand Form-36 score compared at baseline

  2. Measurement of subject satisfaction with treatment on a VAS scale (VAS - Satisfaction) [ Time Frame: 48 weeks ]
    VAS satisfaction score improvement

  3. Measurement of EuroQoL-5D-5L (EQ-5D-5L) [ Time Frame: 24 weeks ]
    EuroQoL -5D-5L score

  4. Measurement of Shoulder Activity Level [ Time Frame: 24 weeks ]
    Recording shoulder activity level

  5. Measurement of shoulder motion (forward elevation, shoulder abduction in the plane of the scapula) [ Time Frame: 24 weeks ]
    As determined by goniometer

  6. MRI-assessed supraspinatus tendon tear location (articular surface, bursal surface, interstitial), tendon tear size and tendon tear percent thickness involvement [ Time Frame: 48 weeks ]
    tendon tear size and tendon thickness



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males and females 30-75 years of age (inclusive).
  2. Subjects have a minimum of three (3) months of clinical symptoms consistent with a partial-thickness rotator cuff tear including but not limited to pain, muscle weakness, or limited active range of motion (AROM).
  3. Subjects have > 70% passive range of motion (PROM) of the index shoulder.
  4. Subjects have a baseline VAS - Pain score of ≥ 30 mm.
  5. Subjects have a partial-thickness rotator cuff tear, defined as ≥25% partial-thickness tear of the supraspinatus tendon on a 3 Tesla (3T) MRI within the last 3 months, as determined by the Investigator.
  6. Subjects can give appropriate consent.

Exclusion Criteria:

  1. Age < 30 or > 75.
  2. Subject has an insufficient amount of subcutaneous tissue to allow recovery of 100 milliliters (mL) of adipose tissue.
  3. Subjects who have received a corticosteroid injection in the index subacromial bursa within the last 3 months.
  4. Subjects who have received more than one (1) previous corticosteroid injections or any biologic treatment in the index subacromial bursa within the past 6 months.
  5. Subjects with severe arthrosis of the glenohumeral or acromioclavicular joint.
  6. Subjects with a full-thickness tear of the rotator cuff.
  7. Subjects who have undergone major surgery on the affected shoulder meeting one of the following criteria:

    • Performed as treatment for (or required manipulation of) the rotator cuff. Examples include, but are not limited to, subacromial decompression, rotator cuff repair, SLAP repair, arthroplasty and fracture fixation with implants that involve or penetrate the rotator cuff; OR
    • Performed using implants that interfere with MR visualization and/or evaluation of the supraspinatus tendon (e.g., biceps tenodesis); OR
    • Performed in/on the glenohumeral joint, subacromial space, or acromioclavicular joint within the last 3 years (e.g. soft tissue Bankart repairs performed >3 years ago may still qualify).

    NOTE: This exclusion criterion does not apply to minor soft tissue procedures with short recovery periods that do not involve musculoskeletal structures (e.g., lipoma excision).

  8. Subjects who were diagnosed with or treated for adhesive capsulitis of the index shoulder within the last 5 years.
  9. Subjects with current cervical radiculopathy impacting the index shoulder.
  10. Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
  11. Subjects with any contraindication to MRI scan according to MRI guidelines, or who are unwilling to undergo MRI procedures.
  12. Subjects whose pain behavior or pain medication usage is, in the opinion of the Investigator, out of proportion to the underlying clinical condition or could interfere with the study- required assessments.
  13. Subjects with a history of systemic malignant neoplasms within the last 5 years.
  14. Subjects with biopsy-proven, malignant or local neoplasm within the last 6 months or any history of local neoplasm at the site of administration (on the affected arm).
  15. Subject is receiving immunosuppressant therapy or has a known immunologic or severe autoimmune disease that requires chronic systemic immunosuppressive or immunomodulatory therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, etc.). [Note: Topical or inhaled corticosteroids are permitted.]
  16. Subject is on an active regimen of chemotherapy or radiation- based treatment.
  17. Subjects with an allergy to sodium citrate or any "caine" type of local anesthetic.
  18. Subject is pregnant or breastfeeding or plans to become pregnant in the next 12 months.
  19. Subjects with clinically significant abnormal Lab tests (i.e. basic metabolic panel (BMP) or equivalent (e.g. CHEM-7), complete blood count (CBC), Liver function tests (LFTs), and prothrombin time/international normalized ratio (PT/INR)) as interpreted by the Investigator.

21. Subjects with a history of a bleeding diathesis or coagulopathy

22. Subject is, in the opinion of the Investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason. Examples include the inability of the subject to complete patient-reported outcome instruments (PROs) and the inability of the Investigator to perform the injection procedure properly because of anatomic limitations of the subject.

23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. (Noninterventional observational studies are not exclusionary.)

24. Subject 1) is a litigant in a civil suit that could affect the subject's ability to complete the study related activities or 2) is a defendant in a criminal case or 3) has an active workman's compensation case in progress.

25. Subject is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal. circumstances or lack of autonomy. This may include: individuals with a mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

26. Uncooperative subjects or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752827


Contacts
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Contact: Hayden Pastorini (713) 440 9900 ext 126 HPastorini@ingeneron.com
Contact: Glenn Winnier, PhD 713 440 9900 gwinnier@ingeneron.com

Locations
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United States, Arizona
Arizona Research Center Recruiting
Phoenix, Arizona, United States, 85053
Contact: Rachel Gledhill       rgledhill@azresearchcenter.com   
Principal Investigator: Joseph Gimbel, MD         
United States, California
Biosolution research Recruiting
La Mesa, California, United States, 91942
Contact: Tamara Tamara Packard       tamara@biosolutionsresearch.com   
Principal Investigator: Peter Hanson, MD         
Lotus Clinical Research, LLC Recruiting
Pasadena, California, United States, 91105
Contact: Nick Sargsyan       nsargsyan@lotuscr.com   
Principal Investigator: Alina Beaton, MD         
United States, Florida
Sports and Orthopedic Center Recruiting
Coral Springs, Florida, United States, 33067
Contact: Danahe Navarrete       dnavarrete@pioneerclinical.com   
Universal Axon Clinical Research Recruiting
Doral, Florida, United States, 33166
Contact: Angel Benitez       Abenitez@uaclinical.com   
Principal Investigator: Luis Martinez, MD         
United States, Georgia
Georgia Institute for Clinical Research Recruiting
Marietta, Georgia, United States, 30060
Contact: Octavia Nichols       octavia.nichols@lowbackpain.com   
Principal Investigator: Anthony Grasso, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Jordyn Sessel       jsessel@med.umich.edu   
Principal Investigator: Tariq Awan, MD         
United States, New Jersey
New Jersey Regenerative Institute Recruiting
Cedar Knolls, New Jersey, United States, 07927
Contact: Katrina Norlander       katrina@njsportsmedicine.com   
Principal Investigator: Gerard Malanga, MD         
United States, North Dakota
Sanford Medical Center Recruiting
Fargo, North Dakota, United States, 58103
Contact: Amy Tuchscherer       amy.tuchscherer@sanfordhealth.org   
Principal Investigator: Mark Lundeen, MD         
United States, South Dakota
Sanford Orthopedic Clinic/Research Recruiting
Sioux Falls, South Dakota, United States, 57104
Contact: Kristen Walsh       kristen.walsh@sanfordhealth.org   
Principal Investigator: Jason Hurd, MD         
United States, Texas
HD Research Recruiting
Houston, Texas, United States, 77041
Contact: Hector Hector Garcia Chavez       hector@minkowitzmd.com   
Principal Investigator: Solanki, MD         
Sponsors and Collaborators
InGeneron, Inc.
Investigators
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Principal Investigator: Jason Hurd, MD Sanford Orthopedics & Sports Medicine
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Responsible Party: InGeneron, Inc.
ClinicalTrials.gov Identifier: NCT03752827    
Other Study ID Numbers: RC-002
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by InGeneron, Inc.:
rotator cuff tear
adipose-derived regenerative cells
adipose-derived stem cells
partial rotator cuff tears
corticosteroid
Additional relevant MeSH terms:
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Tendinopathy
Rotator Cuff Injuries
Wounds and Injuries
Rupture
Shoulder Injuries
Tendon Injuries
Muscular Diseases
Musculoskeletal Diseases