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Stem Cell Therapy

Stem Cell Augmentation for Rotator Cuff Tears

N/A

Waitlist Available

Led By Nikhil N Verma, MD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

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

Must have

Patient is determined to have a full thickness rotator cuff tear (1-3 cm) or partial tear converted to a full-thickness tear on the pre-operative MRI scan or found arthroscopically and is scheduled to undergo surgical repair

Be older than 18 years old

Must not have

Revision surgery

Irreparable tear or partial repair

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Summary

This trial is testing whether adding stem cells to rotator cuff surgery helps the repair better than surgery alone. 100 patients will be followed for at least a year.

Who is the study for?

This trial is for individuals with a full thickness rotator cuff tear measuring 1-3 cm, or those with partial tears that are treated as full. They must be scheduled for surgery and able to give informed consent. It's not open to those lacking decision-making ability, with subscapularis involvement, needing revision surgery, or having irreparable tears.

What is being tested?

The study compares standard arthroscopic rotator cuff repair to the same procedure augmented with mesenchymal stem cells (MSCs), which may improve healing and tendon integrity. The trial will randomly assign patients into two groups and track their recovery over at least one year.

What are the potential side effects?

Potential side effects of MSC augmentation could include pain at the injection site, infection risk increase due to additional intervention, immune system reactions against the stem cells, or complications related to tissue regeneration.

Eligibility Criteria

Inclusion Criteria

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

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I have a full tear in my rotator cuff or a partial tear that will be treated as a full tear, and I am scheduled for surgery.

Exclusion Criteria

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

Select...

I am scheduled for or have had revision surgery.

Select...

I have a tear that cannot be fully repaired.

Select...

I am unable to make my own medical decisions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

American Shoulder and Elbow Surgeons (ASES) Score

Secondary study objectives

Functional Outcomes - Shoulder Exam

Magnetic Resonance Imaging (MRI) Scan

Patient Centered Outcomes - Shoulder Survey

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Rotator cuff repair with stem cellsExperimental Treatment2 Interventions

Using clinically accepted methods, subjects will undergo bone marrow aspiration (from hip, proximal humerus or tibia) through a small incision prior to arthroscopy in the group undergoing MSC augmentation. They will then undergo arthroscopic full thickness rotator cuff repair using a double row, TOE anchor/suture technique with mesenchymal stem cell augmentation.

Group II: Rotator cuff repair without stem cellsPlacebo Group1 Intervention

Subjects will undergo arthroscopic full thickness rotator cuff repair using a double row, TOE anchor/suture technique, without augmentation of mesenchymal stem cells. To maintain patient blinding, all patients will receive a small incision around the site of expected bone marrow aspiration (hip, proximal humerus, or tibia), regardless of whether or not they receive bone marrow.

0 / 4Eligibility criteria met