Stem Cell Augmentation for Rotator Cuff Tears

Recruiting in Palo Alto (17 mi)

Overseen byNikhil N Verma, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Rush University Medical Center

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to compare the clinical outcomes of arthroscopic rotator cuff repair with and without augmentation of mesenchymal stem cells (MSCs). Mesenchymal stem cells promote tissue regeneration by differentiating into adult cell lines and by supplying growth factors to their implanted environment. They have been shown to be effective in improving both overall healing and tendon integrity in rotator cuff repair. This study will follow 100 patients in the United States and track their clinical outcomes for at least one year post-operatively.

Research Team

Nikhil N Verma, MD

Principal Investigator

Midwest Orthopaedics at Rush University

Eligibility Criteria

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.

Inclusion Criteria

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.

Written informed consent is obtained

Exclusion Criteria

I am scheduled for or have had revision surgery.

I have a tear that cannot be fully repaired.

I am unable to make my own medical decisions.

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Treatment Details

Interventions

Mesenchymal Stem Cell Augmentation (Stem Cell Therapy)

Trial OverviewThe 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.

Participant Groups

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.