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

Phase 2

Withdrawn

• Conditions: Rotator Cuff Tears
• Interventions: Drug: Tisseel Injectable Product; Biological: Stromal Vascular Fraction Cells

• Registration Number: NCT05264922
• Lead Sponsor: AdventHealth

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.

Study Timeline

• Study First Submitted: 2021-12-27
• Study Start: 2022-01-09
• Study First Submitted QC: 2022-02-22
• Study First Posted: 2022-03-03
• Primary Completion: 2022-07-22
• Study Completion: 2022-07-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SVF cells and Fibrin Glue	Stromal Vascular Fraction Cells	Nucleated adipose-derived cells loaded in a fibrin glue scaffold
Fibrin Glue	Tisseel Injectable Product	Single 4 milliliter (mL) injection of 0.9% normal saline and fibrin glue solution
SVF cells and Fibrin Glue	Tisseel Injectable Product	Nucleated adipose-derived cells loaded in a fibrin glue scaffold

Primary Outcome Measures

Name	Time	Method
Primary Efficacy - MRI-measured healing rate in the rotator cuff tear	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	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 Outcome Measures

Name	Time	Method
Patient-reported measures Western Ontario Rotator Cuff (WORC) Index	24 months	WORC score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP. The investigators expect the SVF-treated patients to improve by over 12% on the WORC at the final 2-yr follow-up.
Patient-reported measures Patient Reported Outcomes Measurement Information System (PROMIS)	24 months	PROMIS score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP.expect the SVF-treated patients to improve by 10 points on the PROMIS at the final 2-yr follow-up.
Patient-reported measures Visual Analog Scale (VAS)	24 months	Pain VAS score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP. expect the SVF-treated patients to improve by over 12% on the WORC, by 10 points on the PROMIS, and by 20% on the pain VAS by the final 2-yr follow-up. expect the SVF-treated patients to improve by 20% on the pain VAS at the final 2-yr follow-up.

Trial Locations

Locations (1)

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States