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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
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.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
American Shoulder and Elbow Surgeons (ASES) Score
Secondary outcome measures
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.
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,424 Total Patients Enrolled
Nikhil N Verma, MDPrincipal InvestigatorMidwest Orthopaedics at Rush University
2 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.My shoulder muscle is affected.
Research Study Groups:
This trial has the following groups:- Group 1: Rotator cuff repair with stem cells
- Group 2: Rotator cuff repair without stem cells
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Might I be able to partake in this clinical investigation?
"To qualify, potential participants must possess lipocalin 1 and be aged between 18-70 years old. This trial is aiming to recruit a total of 100 individuals."
Answered by AI
What is the size of the cohort for this research endeavor?
"Affirmative, according to records on clinicaltrials.gov this patient-seeking trial is still open for enrollment. It first appeared on November 1st 2015 and was recently modified in June of 2022. The study needs 100 recruits from a single medical centre."
Answered by AI
Does this trial encompass those aged sixty-five and above?
"Adhering to the parameters of this clinical trial, any participants must be within a 18-70 age bracket."
Answered by AI
Are new participants being sought for this investigation?
"Affirmative. According to the details presented on clinicaltrials.gov, this research project is actively searching for participants and has been since November 1st 2015; its last update was June 24th 2022. The team need 100 volunteers from one location."
Answered by AI
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