SVF Cell Therapy for Rotator Cuff Tears

Overseen By Daniel Edon, MS, CSCS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hospital for Special Surgery, New York

Disqualifiers: Diabetes, Hypercholesterolemia, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to enhance healing after rotator cuff surgery. It uses a special cell therapy made from a person's own fat tissue, known as Autologous Stromal Vascular Fraction Material, to determine if it can improve muscle and tendon healing. Participants will receive either this cell therapy or a placebo (a harmless substance resembling the real treatment) during their rotator cuff repair. The trial seeks individuals with a specific type of shoulder tear who have not benefited from physical therapy and have sufficient belly fat for the procedure. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that stromal vascular fraction (SVF) cell therapy is generally safe for people. In a previous study, participants with partial rotator cuff tears received similar treatments and experienced no negative side effects, with improved shoulder function.

These results encourage those considering SVF cell therapy. Although the treatment remains under investigation, studies suggest it is well-tolerated by patients. This indicates it could be a safe option for enhancing muscle and tendon health after rotator cuff surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for rotator cuff tears?

Unlike the standard treatments for rotator cuff tears, which often involve physical therapy and surgical repair, stromal vascular fraction (SVF) cell therapy uses a patient's own cells to promote healing. This therapy is distinctive because it involves injecting SVF material into the injured area, potentially enhancing tissue repair and reducing inflammation naturally. Researchers are excited about SVF cell therapy because it leverages the body's own regenerative capabilities, offering a promising alternative to more invasive surgical options and prolonged recovery times associated with traditional treatments.

What evidence suggests that SVF cell therapy might be an effective treatment for rotator cuff tears?

Research has shown that stromal vascular fraction cells (SVFCs) can aid in healing rotator cuff tears. These cells reduce muscle scarring and fat buildup, resulting in stronger muscles. A previous study found that using SVFCs improved shoulder function without side effects. SVFCs assist by transforming into various cell types that repair tissue and by releasing substances that promote healing. In this trial, participants in the cell therapy arm will receive an injection of SVFCs. Evidence from these studies suggests that SVFCs could enhance recovery from rotator cuff issues. ^{1 2 3 5 6}

Who Is on the Research Team?

Scott Rodeo, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

This trial is for men and women aged 45-65 with a full-thickness tear in the supraspinatus tendon of the rotator cuff, who have enough belly fat for a small liposuction, and whose blood work meets certain standards. They should have tried physical therapy without success. People with diabetes, high cholesterol, significant past illnesses or surgeries, other tendon tears besides supraspinatus, severe joint arthritis, previous rotator cuff repairs or serious arm injuries can't join.

Inclusion Criteria

I have a severe shoulder tendon tear not retracted more than 3 cm.

I am either male or female.

I am between 45 and 65 years old.

Exclusion Criteria

I have had a serious injury or fracture in my arm.

My BMI is either below 20 or above 35.

Your total cholesterol level is very high, at 240mg/dL or more.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Repair and Injection

Participants undergo surgical repair of the rotator cuff and receive an injection of either stromal vascular fraction material or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical repair and injection

12 weeks

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Stomal Vascular Fraction Material

Trial Overview The trial tests if injecting patients' own SVF cells (from their belly fat) into their torn rotator cuff during surgery helps repair better than just using Ringer's solution. The idea is that these cells could turn into muscle or tendon cells or release helpful substances to improve healing after surgery.

How Is the Trial Designed?

Group I: Cell Therapy Active Control 1 Intervention

Patients will receive an injection of stromal vascular fraction material suspended in vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair

Group II: Placebo Placebo Group 1 Intervention

Patients will receive an injection of vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Orthopedic Research and Education Foundation

Collaborator

Trials

23

Recruited

6,200+

Published Research Related to This Trial

In a study involving 421 patients, the administration of autologous stromal vascular fraction (SVF) mixed with platelet-rich plasma (PRP) was found to be safe, with no major adverse events reported, even at doses up to 10 billion SVF cells for intravenous injections.

Adverse events were minor and primarily associated with spinal or intra-articular injections, indicating that the SVF and PRP themselves were not responsible for these issues, suggesting a favorable safety profile for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration. Karina, K., Rosliana, I., Rosadi, I., et al.[2022]

In a study involving adult immunodeficient rats with chronic rotator cuff tears, injections of stromal vascular fraction stem cells (SVFCs) led to a significant 40% reduction in fibrosis compared to control groups, indicating potential for improved muscle healing.

While SVFC treatment did not show differences in lipid content or overall muscle force production, the presence of human DNA and protein in treated muscles suggests that SVFCs may enhance recovery from chronic rotator cuff injuries by reducing fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stromal vascular stem cell treatment decreases muscle fibrosis following chronic rotator cuff tear. Gumucio, JP., Flood, MD., Roche, SM., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03332238

Stromal Vascular Fraction Cell Therapy to Improve the ... This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32238172/

Safety and efficacy of treating symptomatic ... This pilot study suggests that the use of UA-ADRCs in subjects with sPTRCT is safe and leads to improved shoulder function without adverse effects.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05264922

Stromal Vascular Fraction (SVF) Cells for Non-Operative ... The investigator's goal is to determine the effectiveness of stromal vascular fraction (SVF) cell injection to treat small rotator cuff tears without surgery.

4. nature.com nature.com/articles/s41598-023-46653-4

Management of partial-thickness rotator cuff tears with ... Management of partial-thickness rotator cuff tears with autologous adipose-derived regenerative cells is safe and more effective than injection ...

5. withpower.com withpower.com/trial/phase-3-muscular-atrophy-6-2019-d65f0

SVF Cell Therapy for Rotator Cuff Tears · Info for Participants Research shows that stromal vascular fraction stem cells (SVFCs) can help reduce muscle fibrosis (scarring) and fat accumulation, and improve muscle strength ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6213833/

Effects of Local Application of Adipose-Derived Stromal ... To the Editor: Previous studies showed that the rate of retears after repair of rotator cuff injury was 38–94%, owing to the low healing capability of ...