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Could your own muscle fibers help fix a torn rotator cuff?

NCT ID NCT03752034

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether injecting a person's own muscle fibers into the shoulder muscle can safely improve strength and function after rotator cuff repair. Researchers take a small sample of chest muscle, break it into tiny fragments, and inject them into the torn muscle during surgery. The trial involves 20 adults aged 40 to 80 with small tears, and its main goal is to check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous muscle fiber fragments
What this could lead to
If it works, this could lead to a new way to improve muscle strength and function after rotator cuff surgery.
What could go wrong
This is a very small, early safety study with only 20 people. It is not designed to prove effectiveness, and there may be risks from the biopsy or injection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males and females, ages 40 to 80 years * Unilateral Disease * \< 1.5cm tear Exclusion Criteria: * Diabetes * Peripheral Neuropathy * Previous Shoulder Surgery * Pain Syndrome; cuff arthroplasty * Major co-morbidities including, but not limited to, uncontrolled diabetes, cardiovascular, pulmonary, GI, coagulopathies * Arthritis of Shoulder * Unwilling or unable to comply with post-operative instructions or follow-up visits * Auto Immune Disease * Complete Subscapularis Tear * Teres Minor involvement * History of testing positive for HIV, Hep B, Hep C, HTLV-1, HTLV-2 * Pregnancy * Implanted devices containing ferromagnetic material * Any implanted electrical stimulation devices (i.e. cochlear implant, defibrillator) * Any other condition which the PI feels would be not in the best interest for the patient or the study

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Conditions

The condition(s) this trial relates to.

rotator cuff syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rotator cuff

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

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