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

Running, not enrolling · Not applicable

Conditions studied: Rotator Cuff Tear, Rotator Cuff Tendinitis

In brief

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.

Key facts

Study ID

NCT03752827

Run by

InGeneron, Inc.

People needed

168

Starts

2019-05-13

Expected to finish

2025-12-01

Last updated by the study team

2025-08-20

Who can join

Age: 30 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females 30-75 years of age (inclusive).
• 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).
• Subjects have > 70% passive range of motion (PROM) of the index shoulder.
• Subjects have a baseline VAS - Pain score of ≥ 30 mm.
• Subjects have a partial-thickness rotator cuff tear, defined as ≥25% partial-thickness tear of the supraspinatus tendon on a 1.5 Tesla (1.5T) or a 3 Tesla (3T) MRI within the last 3 months, as determined by the Investigator.
• Subjects can give appropriate consent.

You may not qualify if…

• Age < 30 or > 75.
• Subject has an insufficient amount of subcutaneous tissue to allow recovery of 100 milliliters (mL) of adipose tissue.
• Subjects who have received a corticosteroid injection in the index subacromial bursa within the last 3 months.
• 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.
• Subjects with severe arthrosis of the glenohumeral or acromioclavicular joint.
• Subjects with a full-thickness tear of the rotator cuff.
• 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).
• Subjects who were diagnosed with or treated for adhesive capsulitis of the index shoulder within the last 5 years.
• Subjects with current cervical radiculopathy impacting the index shoulder.
• Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane.
• Subjects with any contraindication to MRI scan according to MRI guidelines, or who are unwilling to undergo MRI procedures.
• 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.
• Subjects with a history of systemic malignant neoplasms within the last 5 years.
• 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), excluding basal cell carcinoma.
• 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.]
• Subject is on an active regimen of chemotherapy or radiation- based treatment.
• Subjects with an allergy to sodium citrate or any "caine" type of local anesthetic.
• Subject is pregnant or breastfeeding or plans to become pregnant in the next 12 months.
• 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.
• Subjects with a history of a bleeding diathesis or coagulopathy
• 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.

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Biosolutions Clinical Research Center — La Mesa, California, United States
• Lotus Clinical Research, LLC — Pasadena, California, United States
• Sports and Orthopedic Center — Coral Springs, Florida, United States
• Universal Axon Clinical Research — Doral, Florida, United States
• Shrock Clinical Research — Fort Lauderdale, Florida, United States
• Andrews Institute for Orthopaedics and Sports Medicine — Gulf Breeze, Florida, United States
• Georgia Institute for Clinical Research — Marietta, Georgia, United States
• Tulane University School of Medicine — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Sanford Medical Center — Fargo, North Dakota, United States
• Sanford Orthopedic Clinic/Research — Sioux Falls, South Dakota, United States
• HD Research — Houston, Texas, United States
• Texas Plastic Surgery — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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