Muscle Fiber Fragments for Rotator Cuff Injury

Recruiting in Palo Alto (17 mi)

Overseen by Gary G Poehling, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Diabetes, Neuropathy, Surgery, Arthritis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial involves injecting small pieces of a patient's own muscle into their shoulder to help strengthen a weakened rotator cuff muscle. The goal is for these muscle pieces to integrate and grow, improving muscle size and function.

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 study team or your doctor.

How is the Muscle Fiber Fragments treatment different from other treatments for rotator cuff injury?

Muscle Fiber Fragments (MFFs) treatment is unique because it focuses on enhancing muscle regeneration and reducing fibrosis (thickening and scarring of tissue) and fat accumulation in the muscle, which are common issues in chronic rotator cuff injuries. This approach is different from traditional treatments that may not directly target these specific muscle changes. ^{1 2 3 4 5}

Research Team

Gary G Poehling, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for men and women aged 40-80 with a rotator cuff tear smaller than 1.5cm, without diabetes, arthritis of the shoulder, autoimmune diseases, certain viral infections (HIV, Hepatitis B/C), or previous shoulder surgeries. Participants must be able to follow post-op instructions and attend follow-up visits.

Inclusion Criteria

My condition affects only one side of my body.

I am between 40 and 80 years old.

The tear in your body is less than 1.5 centimeters in size.

Exclusion Criteria

You have an autoimmune disease, which is a condition where the body's immune system attacks its own healthy cells.

I do not have uncontrolled health issues like diabetes or heart problems.

I have a complete tear in my shoulder muscle.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo rotator cuff repair and receive direct injection of Muscle Fiber Fragments (MFFs) into the supraspinatus muscle

Immediate (during surgery)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including muscle recovery and adverse events

6 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Muscle Fiber Fragments (MFFs) (Other)

Trial Overview The study tests if injecting Muscle Fiber Fragments (MFFs) into the supraspinatus muscle during repair surgery can integrate with existing muscle to improve its size and strength, potentially enhancing rotator cuff function and stability.

Participant Groups

Group I: Muscle Fiber Fragments (MFF) Experimental Treatment 1 Intervention

Participants undergoing rotator cuff repair will have autologous muscle tissue harvested. The tissue will be processed to obtain Muscle Fiber Fragments (MFFs) and administered via direct injection into the supraspinatus muscle belly.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Findings from Research

In a study involving eight dogs with surgically detached infraspinatus tendons, significant changes were observed after twelve weeks: muscle stiffness increased dramatically, while muscle volume decreased by an average of 32% within the first six weeks.

The study found that intramuscular fat content increased significantly in the detached muscles, indicating that a chronically detached muscle undergoes substantial changes, becoming stiffer and less functional, which complicates potential repair efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in rotator cuff muscle volume, fat content, and passive mechanics after chronic detachment in a canine model. Safran, O., Derwin, KA., Powell, K., 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]

Muscle fibers from patients with chronic rotator cuff tears show a significant reduction in force production, with a 30% decrease in maximum isometric force compared to healthy controls, indicating impaired muscle function.

The study found that the force production of supraspinatus muscle fibers correlates positively with shoulder function (measured by ASES scores) and negatively with the size of the tear, suggesting that both muscle integrity and tear severity impact recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced muscle fiber force production and disrupted myofibril architecture in patients with chronic rotator cuff tears. Mendias, CL., Roche, SM., Harning, JA., et al.[2018]

The study found that the newly developed 3D fat fraction (3D-FF) measurement is superior to the traditional 2D fat fraction (2D-FF) in accurately assessing intramuscular fat distribution in the supraspinatus muscle of patients with rotator cuff tears, showing significant differences in fat measurements.

3D-FF demonstrated better reliability and agreement between observers compared to 2D-FF, with intraclass correlation coefficients indicating high consistency (0.89-0.99 for 3D-FF vs. 0.71-0.95 for 2D-FF), making it a more trustworthy method for evaluating fatty infiltration in rotator cuff injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of 3-dimensional Measurements for Supraspinatus Intramuscular Fatty Evaluation in Patients With Medium to Massive Rotator Cuff Tears: Comparison With a Single Sagittal Slice. Liu, B., Xu, J., Jin, Y., et al.[2022]

In a study using elderly rats with massive rotator cuff tears, researchers found a significant reduction in muscle fiber force and an increase in gene expression related to muscle atrophy and inflammation after 30 days, indicating severe degenerative changes in the muscle.

The study revealed that the accumulation of fat in the muscles following chronic cuff tears does not follow the typical pathways for fat storage, suggesting a unique mechanism of fatty degeneration in these injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aging-associated exacerbation in fatty degeneration and infiltration after rotator cuff tear. Gumucio, JP., Korn, MA., Saripalli, AL., et al.[2021]

References

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

Changes in rotator cuff muscle volume, fat content, and passive mechanics after chronic detachment in a canine model. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

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

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

Reduced muscle fiber force production and disrupted myofibril architecture in patients with chronic rotator cuff tears. [2018]

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

Advantages of 3-dimensional Measurements for Supraspinatus Intramuscular Fatty Evaluation in Patients With Medium to Massive Rotator Cuff Tears: Comparison With a Single Sagittal Slice. [2022]

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

Aging-associated exacerbation in fatty degeneration and infiltration after rotator cuff tear. [2021]