What side effects are associated with this type of intervention?

Common treatments for rotator cuff injuries include physical therapy, corticosteroid injections, and surgical interventions. Physical therapy generally has minimal side effects but may cause temporary discomfort. Corticosteroid injections can provide short-term pain relief but may lead to tendon weakening and potential rupture with repeated use. Surgical interventions carry risks such as infection, stiffness, and complications from anesthesia. For biologic therapies like platelet-rich plasma (PRP) and stem cell injections, which are somewhat similar to muscle fiber fragment injections, side effects can include pain at the injection site, infection, and inflammation. These treatments are still under investigation, and their long-term safety profiles are not fully established.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments that directly mirror the investigational Muscle Fiber Fragments (MFF) injection for rotator cuff injuries. Current FDA-approved treatments for rotator cuff injuries primarily include surgical repair techniques, physical therapy, and corticosteroid injections to manage pain and inflammation. Biologic therapies such as platelet-rich plasma (PRP) and stem cell injections are being explored in clinical trials but have not yet received FDA approval specifically for rotator cuff repair.

What other types of research exist?

Promising novel alternatives to Muscle Fiber Fragments Injection for rotator cuff patients include: <ol> <li>Topical nitroglycerin: May improve tendon healing by stimulating collagen synthesis.</li> <li></li> </ol> Ultrasound-guided percutaneous needle tenotomy: Involves fenestrating tendinotic tissue to promote healing. 3. Prolotherapy: Involves injecting a local irritant to elicit an inflammatory response and promote healing. 4. Sclerosing polidocanol injection: Targets neovessels to reduce pain and improve function. 5. Autologous tenocyte injection: Uses patient's own tenocytes to promote tendon healing.

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Muscle Fiber Fragments for Rotator Cuff Injury

N/A

Recruiting

Led By Gary G Poehling, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral Disease

Males and females, ages 40 to 80 years

Must not have

Major co-morbidities including, but not limited to, uncontrolled diabetes, cardiovascular, pulmonary, GI, coagulopathies

Complete Subscapularis Tear

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks, 6 months post operatively

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed in the provided information but may include typical surgical risks such as infection or reaction at the biopsy site where MFFs are harvested and injected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition affects only one side of my body.

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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a complete tear in my shoulder muscle.

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I have nerve damage in my hands or feet.

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I have had shoulder surgery before.

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I have arthritis in my shoulder.

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I have tested positive for HIV, Hepatitis B, Hepatitis C, HTLV-1, or HTLV-2.

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I am willing and able to follow post-surgery instructions and attend follow-up visits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks, 6 months post operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks, 6 months post operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks, 6 months post operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events

Secondary study objectives

ASES Shoulder Score

Constant Score

Dynamometer measurements

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Muscle Fiber Fragments (MFF)Experimental Treatment1 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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for rotator cuff injuries include physical therapy, corticosteroid injections, and surgical repair. Physical therapy aims to strengthen the surrounding muscles and improve flexibility, reducing strain on the rotator cuff. Corticosteroid injections reduce inflammation and pain, providing temporary relief. Surgical repair involves reattaching the torn tendon to the bone. Muscle fiber fragment (MFF) injections, as studied in recent trials, involve injecting small muscle fiber fragments into the injured area to promote muscle regeneration and integration with existing muscle tissue. This approach aims to enhance muscle size and strength, improving overall function and stability of the rotator cuff. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options, potentially leading to better outcomes and faster recovery.