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

56 Participants Needed

Trial Summary

What is the purpose of this trial?

Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. 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 cuff.

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.

What data supports the effectiveness of the treatment Autologous Stomal Vascular Fraction Material for rotator cuff tears?

Research shows that stromal vascular fraction stem cells (SVFCs) can help reduce muscle fibrosis (scarring) and fat accumulation, and improve muscle strength after chronic rotator cuff tears. Additionally, studies in rabbits indicate that adipose-derived stromal vascular fraction (ADSVF) has a better potential for healing tendon injuries compared to other stem cell treatments. ^{1 2 3 4 5}

Is SVF cell therapy safe for humans?

SVF cell therapy has been used in various clinical settings, including bone fracture repair and treatment of degenerative diseases, with no reported adverse effects, suggesting it is generally safe for humans. ^{3 5 6 7 8}

How does SVF cell therapy differ from other treatments for rotator cuff tears?

SVF cell therapy is unique because it uses stromal vascular fraction stem cells to enhance muscle regeneration and reduce fibrosis (scarring) and fat accumulation in the muscle after a rotator cuff tear, which is not typically addressed by standard surgical repairs. ^{3 4 6 9 10}

Research Team

Scott Rodeo, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Rotator cuff regeneration using a bioabsorbable material with bone marrow-derived mesenchymal stem cells in a rabbit model. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intratendinous Injection of Mesenchymal Stem Cells for the Treatment of Rotator Cuff Disease: A 2-Year Follow-Up Study. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Stromal vascular stem cell treatment decreases muscle fibrosis following chronic rotator cuff tear. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Isolation and characterization of 2 new human rotator cuff and long head of biceps tendon cells possessing stem cell-like self-renewal and multipotential differentiation capacity. [2022]

5. China pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Imaging and Biomechanical Analysis of Adipose-derived Stromal Vascular Fraction Applied on Rotator Cuff Repair in Rabbits. [2022]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

[Use of cultured human autologous bone marrow stem cells in repair of a rotator cuff tear: preliminary results of a safety study]. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Implantation of Stromal Vascular Fraction Progenitors at Bone Fracture Sites: From a Rat Model to a First-in-Man Study. [2018]

8. Egypt pubmed.ncbi.nlm.nih.gov

Safety of Technique and Procedure of Stromal Vascular Fraction Therapy: From Liposuction to Cell Administration. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Enhanced Repaired Enthesis Using Tenogenically Differentiated Adipose-Derived Stem Cells in a Murine Rotator Cuff Injury Model. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Mesenchymal Stem Cells From a Hypoxic Culture Can Improve Rotator Cuff Tear Repair. [2022]