Mesenchymal stem cell augmentation in rotator cuff repair for Rotator Cuff Tear

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rotator Cuff TearMesenchymal stem cell augmentation in rotator cuff repair - Biological
Eligibility
18 - 70
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Rotator Cuff Tear

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 1 year

1 year
Magnetic Resonance Imaging (MRI) Scan
Year 1
Functional Outcomes - Shoulder Exam
Patient Centered Outcomes - Shoulder Survey
One year
American Shoulder and Elbow Surgeons (ASES) Score

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Rotator cuff repair with stem cells
1 of 2
Rotator cuff repair without stem cells
1 of 2

Experimental Treatment

Non-Treatment Group

100 Total Participants · 2 Treatment Groups

Primary Treatment: Mesenchymal stem cell augmentation in rotator cuff repair · Has Placebo Group · N/A

Rotator cuff repair with stem cellsExperimental Group · 2 Interventions: Standard arthroscopic rotator cuff repair, Mesenchymal stem cell augmentation in rotator cuff repair · Intervention Types: Procedure, Biological
Rotator cuff repair without stem cells
Procedure
PlaceboComparator Group · 1 Intervention: Standard arthroscopic rotator cuff repair · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
390 Previous Clinical Trials
153,484 Total Patients Enrolled
Nikhil N Verma, MDPrincipal InvestigatorMidwest Orthopaedics at Rush University
2 Previous Clinical Trials

Eligibility Criteria

Age 18 - 70 · All Participants · 2 Total Inclusion Criteria

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References