Muscle Fiber Fragments for Rotator Cuff Injury

Overseen By Mary-Clare Day, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Diabetes, Neuropathy, Surgery, Arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate (during surgery)

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with a rotator cuff injury. The process involves taking a small sample of chest muscle, converting it into tiny strands called Muscle Fiber Fragments (MFFs), and injecting them into the shoulder muscle. The goal is to determine if these MFFs can strengthen and stabilize the shoulder. Individuals with a rotator cuff tear less than 1.5 cm and no previous shoulder surgery may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new treatment options.

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.

What prior data suggests that this method is safe for rotator cuff injury treatment?

Research has shown that injecting Muscle Fiber Fragments (MFFs) into weakened rotator cuff muscles is expected to be safe. These small muscle pieces can help rebuild and strengthen the damaged area. Researchers believe that MFFs can be safely injected into muscles that have shrunk due to injury.

Although specific data on reactions to MFFs remains limited, the process uses the patient's own muscle tissue, which typically reduces the risk of adverse reactions. Studies so far suggest that this method could help muscles regain strength and function after a rotator cuff injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Muscle Fiber Fragments (MFFs) are unique because they use the patient's own muscle tissue to aid in healing rotator cuff injuries. Unlike standard treatments like physical therapy or surgical repair alone, MFFs involve harvesting and injecting muscle tissue fragments directly into the injured area. This innovative approach aims to enhance the body’s natural repair process by introducing new muscle fibers directly where they are needed. Researchers are excited about MFFs because they could potentially improve recovery times and outcomes compared to conventional methods.

What evidence suggests that Muscle Fiber Fragments might be an effective treatment for rotator cuff injury?

Research has shown that small pieces of muscle fibers, called muscle fiber fragments (MFFs), might help improve muscle function. In this trial, participants undergoing rotator cuff repair will receive MFFs via direct injection into the supraspinatus muscle belly. Studies suggest that injecting these fragments into muscles can help restore their function and increase strength. For rotator cuff injuries, the goal is for MFFs to integrate with the existing muscle, enhancing size and stability. Early results from similar treatments, such as those used for bladder muscle repair, have been positive. This indicates that MFF therapy could aid in muscle healing and improve shoulder function. ^{2 6 7 8 9}

Who Is on the Research Team?

Gary G Poehling, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Muscle Fiber Fragments (MFFs)

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/66321?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Muscle Fiber Fragments for Improved Function of Rotator C... Muscle fiber fragment (MFF) therapy has shown pre-clinical and clinical promise in the treatment of bladder neck insufficiency/incompetent ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4686437/

Rotator cuff tears: An evidence based approach Predictable success, pain relief and patient satisfaction has been met with after repair of RC tears[108]. In a recent study on 103 shoulder surgeons, Robinson ...

3. ctv.veeva.com ctv.veeva.com/study/muscle-fiber-fragments-for-improved-function-of-rotator-cuff-musculature-following-rotator-cuff-repa

Muscle Fiber Fragments for Improved Function of Rotator Cuff ... The Investigators anticipate that the MFFs can safely be injected into the atrophied rotator cuff muscle and will help restore the functional ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2214031X22000547

Clinical perspectives for repairing rotator cuff injuries with ... This review aims to bridge clinical, tissue engineering, and biological aspects of rotator cuff repair and propose a novel therapeutic strategy.

5. fortunejournals.com fortunejournals.com/articles/understanding-fibrous-tissue-in-the-effective-healing-of-rotator-cuff-injury.html

Understanding Fibrous Tissue in the Effective Healing of ... Studies injecting MSC secretomes into rodent models with induced massive rotator cuff tears showed a reduction in muscle fatty degeneration and atrophy, with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3449033/

Rotator cuff tear reduces muscle fiber specific force production ... 30 days after inducing a tear, a 53% reduction in supraspinatus muscle mass and a 45% reduction in infraspinatus muscle mass occurred compared with control ...

7. mdpi.com mdpi.com/1422-0067/25/21/11742

A Study of the Biomarkers Pax7, MyoD, and Myogenin Our findings suggest that the supraspinatus muscle in tear conditions showed signs of initial activation of muscle regeneration. When compared to the unaffected ...

8. smartpatients.com smartpatients.com/trials/NCT03752034

Muscle Fiber Fragments for Improved Function of Rotator ... In this study, a chest muscle sample (biopsy) will be taken and the muscle fibers will be removed from the sample and made into smaller strands or fragments.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4390944/

Muscle Fibers are Injured at the Time of Acute and Chronic ... The results from our study suggest that repairing either acutely or chronically torn rotator cuff tears causes damage to muscle fibers, but the degree of the ...