Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears

1719310

The investigator's goal is to determine the effectiveness of stromal vascular fraction (SVF) cell injection to treat small rotator cuff tears without surgery.

2022-01-09

2022-07-22

2022-07-22

Withdrawn

Early phase I

Inclusion Criteria 1. Male and female patients 30-65 years of age 2. Symptomatic partial-thickness rotator cuff tears 3. Suitable candidate for lipoaspiration and autologous adipose derived stem cell therapy as per physician. Exclusion Criteria 1. History of RC repair of affected shoulder, osteomyelitis or septic arthritis; 2. Primary diagnosis of osteoarthritis, primary adhesive capsulitis; 3. Full thickness rotator cuff tear 4. RC tear of the subscapularis (SSc) or teres minor (TM), or a RC tear at the musculotendinous junction. 5. Prescribed physical therapy or injection (of any nature) to shoulder prior to initial visit (within past 3 months); 6. Clinically significant medical diseases that can impact tissue healing (i.e. Cardiovascular/peripheral vascular disease, diabetes, cancer, endocrine disease, hepatic disease (hepatitis), renal disease, autoimmune/inflammatory disease, HIV; 7. Cervical spine radiculopathy; 8. Current anticoagulation therapy (excluding Aspirin 81mg), immunosuppressant medication, narcotic use; 9. Women of child bearing potential must test negative on standard urine pregnancy test and must agree to practice appropriate contraception for the first year of the study (i.e. oral contraceptive, barrier method, intrauterine device (IUD), intramuscular contraceptive); 10. Subjects with abnormal hematology or serum chemistry lab results, outside of the normal range, as defined by the American Board of Internal Medicine (ABIM) Laboratory Test Reference Ranges, which are clinically significant, in the opinion of the investigator; 11. BMI greater than 40 kg/m2; 12. History of tobacco use within last 3 years; 13. Subject has been diagnosed with any bleeding disorders, including but not limited to: hemophilia A or B, Von Willebrand Disease; 14. Currently participating, or has participated in any other clinical trials within 6 months prior to the screening visit; 15. Subjects has any significant medical condition, that in the option of the investigator, would make them unable to provide informed consent and/or interfere with their compliance of study requirements; 16. Subject has a documented allergy to the anesthetic or any component of the injectable, including but not limited to: aprotinin. 17. Subject has a contraindication for completing the MRI (i.e. pacemaker, aneurysm clip, metal fragments, etc that may become dislodged) or has problems with loud noises or claustrophobia.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized 1:1 to SVF Cells \\& Fibrin Glue or Fibrin Glue alone.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The provider (PI) and team performing the injection will not care for the subject during follow up.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-02-15