Could donor cells boost rotator cuff repair? early trial begins

NCT ID NCT04057833

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

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This early-phase trial tests whether injecting special donor cells (E-CEL UVEC) into the shoulder during rotator cuff surgery is safe and might improve healing. Twenty adults aged 45-70 with full-thickness tears will receive the cells at the repair site. The main goal is to check for side effects in the first 11 days and up to a year after surgery.

What this could mean

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

Active substance: E-CEL UVEC cells (donor cells injected at the repair site)
What this could lead to: If it works, this could lead to a way to help rotator cuff tears heal better after surgery, reducing re-tears and improving recovery.
What could go wrong: This is a very early phase 1 safety trial with only 20 people. It is not designed to prove effectiveness, and the cells may not improve healing or could cause side effects like pain or swelling.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

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

Oct 2026

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 70 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: * Adults aged 45-70 years old * Diagnosis of full-thickness supraspinatus tendon tear by MRI and physical examination * Tendon retraction 1 to 3 cm on MRI * Goutallier score ≤ grade 2. * Failed standard non-operative treatments for tendon tear including a minimum of 3 months of physical therapy as well as oral anti-inflammatory medications, subacromial steroid injection, activity modification, etc. Exclusion Criteria: * Tears of any cuff tendon other than the supraspinatus * Frank signs of glenohumeral osteoarthritis on MRI * Diagnosis of acute tendon tear * Lack of significant pain and/or loss of function due to tendon tear History of previous rotator cuff repair * History of upper extremity fracture or other moderate to severe upper extremity trauma * BMI \< 20 or \> 35 * Diagnosis of Type I or type II diabetes, or other metabolic disorders * Previous history of cancer. Subjects with cervical carcinoma in situ or localized basal or squamous cell carcinoma treated with definitive surgery are eligible. * Diagnosis of an autoimmune disorder Know history of HIV * Current use of nicotine products * History of diabetes, malignancy within 5 years of the procedure, immunosuppression, autoimmune or connective tissue disorders such as lupus or rheumatoid arthritis, schizophrenia or other psychiatric disorder that could interfere with postoperative rehabilitation, or other disability that would obviously adversely impact the patient's ability to participate in standard postoperative rehabilitation * Pregnancy * Inability to comply with post-operative rehabilitation * Hypersensitivity reactions to bovine (cow) proteins

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Conditions

The condition(s) this trial relates to.

Asthenia 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 or weakness Rotator cuff tears Safety issues Tendon rupture - shoulder

Could donor cells boost rotator cuff repair? early trial begins

What the study statuses mean