This is a prospective, randomized, multi-site, safety and efficacy study in subjects with rotator cuff injuries.
Patients will fall into two categories: treatment group (12 subjects) and non-treatment or control group (six subjects). The treatment group will undergo a small liposuction procedure and receive rotator cuff repair treatment with an ultrasound-guided injection of 5cc adipose-derived stem cells (ADSCs) into the point of injury. The control group will receive a 5cc cortisone injection into the point of injury
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males and females 30-75 years of age.
✓. Clinical symptoms consistent with a rotator cuff lesion including but not limited to pain, muscle weakness, or active-limited range of motion (AROM).
✓. Subjects who have not responded to physical therapy treatments for at least six weeks.
✓. Subjects with \> 70% passive range of motion (PROM).
✓. Diagnosed with \>50% tear to supraspinatus muscle or \< 5mm separation assessed by MRI.
✓. Diagnosed with a partial-thickness rotator cuff tear
✓. The ability of subjects to give appropriate consent or have an appropriate representative available.
Exclusion criteria
✕. Age \<30 or \> 75
✕. Insufficient amount of subcutaneous tissue to allow recovery of 50cc of lipoaspirate.
✕. History of systemic malignant neoplasms within last 5 years.
✕. History of local neoplasm within the last 6 months and any history of local neoplasm at site of administration.
✕. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
What they're measuring
1
safety evaluation as indicated by collection of adverse events
Timeframe: enrollment through 12months of follow-up