Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears
Overview
- Phase
- Phase 2
- Intervention
- Tisseel Injectable Product
- Conditions
- Rotator Cuff Tears
- Sponsor
- AdventHealth
- Locations
- 1
- Primary Endpoint
- Primary Efficacy - MRI-measured healing rate in the rotator cuff tear
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
The investigator's goal is to determine the effectiveness of stromal vascular fraction (SVF) cell injection to treat small rotator cuff tears without surgery.
Detailed Description
Small rotator cuff tendon tears are a hard task in shoulder care. They are often not operated on because research has not shown any increased benefit of surgery over physical therapy. The most common way to treat these tears is through physical therapy or steroid injections. However, the relief doesn't last very long. Recent studies have shown a lot of tears get worse over time. This happens because the physical therapy options can treat the pain and symptoms, but do not heal the actual tear. Another non-surgical option for treating small tears is through adipose-derived stem cells. Adipose-derived stem cells are cells that are found in the fat in our bodies. The cells have shown promise in fixing tissues and may provide help to treat small rotator cuff tears. The investigators are studying a part of these fat cells known as the stromal vascular fraction (SVF). The SVF contains a number of cells that are able to become a variety of different cells. This is important because they may be able to turn into cells that may help heal the damaged rotator cuff tendons. These cells have been shown to improve results after rotator cuff surgery, but no research has used these cells to help small tears without surgery. The use of SVF is investigational. "Investigational" means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA). The FDA is allowing the use of this drug for research. The investigators goal is to determine the effectiveness of SVF cell injection to treat small rotator cuff tears without surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Fibrin Glue
Single 4 milliliter (mL) injection of 0.9% normal saline and fibrin glue solution
Intervention: Tisseel Injectable Product
SVF cells and Fibrin Glue
Nucleated adipose-derived cells loaded in a fibrin glue scaffold
Intervention: Tisseel Injectable Product
SVF cells and Fibrin Glue
Nucleated adipose-derived cells loaded in a fibrin glue scaffold
Intervention: Stromal Vascular Fraction Cells
Outcomes
Primary Outcomes
Primary Efficacy - MRI-measured healing rate in the rotator cuff tear
Time Frame: 24 months
Healing rates between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group.
Primary Safety - Incidence/Rates of adverse events (AEs) involving the affected joint
Time Frame: 24 months
Both study-related AE assessments and the clinical record will be interrogated to determine if the subjects had any adverse events involving the affected joint. Incidence and rates of AEs between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group.
Secondary Outcomes
- Patient-reported measures Western Ontario Rotator Cuff (WORC) Index(24 months)
- Patient-reported measures Patient Reported Outcomes Measurement Information System (PROMIS)(24 months)
- Patient-reported measures Visual Analog Scale (VAS)(24 months)