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.
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Improvement in Pain: VAS
Timeframe: 24 weeks
2
Improvement or no worsening in supraspinatus strength