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Can your own fat cells fix a torn rotator cuff?

NCT ID NCT03332238

Disease control Sponsor: Hospital for Special Surgery, New York Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether a patient's own fat-derived cells (stromal vascular fraction) can improve healing after surgical repair of a chronic rotator cuff tear. The study enrolls 56 adults aged 45-65 with full-thickness tears who have not improved with physical therapy. The cells are isolated from a small amount of belly fat during surgery and injected into the repair site. Researchers will measure shoulder strength, pain, and function over time.

What this could mean

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

Active substance
stromal vascular fraction cells from the patient's own fat tissue
What this could lead to
If it works, this could lead to a treatment that improves muscle and tendon healing after rotator cuff surgery, reducing pain and weakness.
What could go wrong
This is a small, early-phase trial (56 people) with no control group for comparison. The cells may not improve outcomes, and the procedure involves liposuction and surgery risks.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 56 people

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

Started

Jul 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

45 to 65 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 * Age 45-65 years old at the time of enrollment * Full-thickness supraspinatus tendon tear with endon retraction ≤ 3 cm * Magnetic resonance imaging Goutallier score ≤ grade 2 * Completed at least 6 weeks of standard physical therapy but continue to have pain and limited function (failed physical therapy) * Sufficient subcutaneous abdominal adipose tissue to allow the recovery of 60-120cc of lipoaspirate * Must pass standard of care blood work screening Exclusion Criteria: * Any tears of any cuff tendon other than the supraspinatus * Magnetic resonance imaging Goutallier scores ≥ 3 * Frank signs of glenohumeral osteoarthritis on magnetic resonance imaging * A history of previous rotator cuff repair * A history of upper extremity fracture or other moderate to severe upper extremity trauma * A BMI \< 20 or \> 35 * Pregnant or breast feeding * Premenopausal women who are not using contraception * Previous abdominal liposuction or any major open abdominal surgery * Type I or type II diabetes, or glycated hemoglobin (hemoglobin A1C) values \> 6.5 or other metabolic disorders * Hypercholesterolemia (total cholesterol ≥240mg/dL) * History of cancer * Autoimmune disorder or HIV+ status * Use of nicotine products * Have any other history of major medical illness, disease or other relevant orthopaedic disability * Who do not speak English * Liodcaine allergy

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Conditions

The condition(s) this trial relates to.

muscular atrophy Rotator Cuff Injuries rotator cuff syndrome

As listed by the trial registrant

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

Muscle atrophy Rotator cuff tear Tendon tear

Contacts and locations

Locations

  • Hospital for Special Surgery

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.