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Muscle Fiber Fragments for Rotator Cuff Injury
N/A
Recruiting
Led By Gary G Poehling, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unilateral Disease
Males and females, ages 40 to 80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks, 6 months post operatively
Awards & highlights
Study Summary
This trial will test whether chest muscle fragments can improve rotator cuff function.
Who is the study for?
This trial is for men and women aged 40-80 with a rotator cuff tear smaller than 1.5cm, without diabetes, arthritis of the shoulder, autoimmune diseases, certain viral infections (HIV, Hepatitis B/C), or previous shoulder surgeries. Participants must be able to follow post-op instructions and attend follow-up visits.Check my eligibility
What is being tested?
The study tests if injecting Muscle Fiber Fragments (MFFs) into the supraspinatus muscle during repair surgery can integrate with existing muscle to improve its size and strength, potentially enhancing rotator cuff function and stability.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information but may include typical surgical risks such as infection or reaction at the biopsy site where MFFs are harvested and injected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition affects only one side of my body.
Select...
I am between 40 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks, 6 months post operatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks, 6 months post operatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events
Secondary outcome measures
ASES Shoulder Score
Constant Score
Dynamometer measurements
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Muscle Fiber Fragments (MFF)Experimental Treatment1 Intervention
Participants undergoing rotator cuff repair will have autologous muscle tissue harvested. The tissue will be processed to obtain Muscle Fiber Fragments (MFFs) and administered via direct injection into the supraspinatus muscle belly.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,250 Previous Clinical Trials
1,007,133 Total Patients Enrolled
Gary G Poehling, MDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition affects only one side of my body.I am between 40 and 80 years old.You have an autoimmune disease, which is a condition where the body's immune system attacks its own healthy cells.I do not have uncontrolled health issues like diabetes or heart problems.I have a complete tear in my shoulder muscle.I have nerve damage in my hands or feet.You are pregnant.I have pain from shoulder replacement surgery.I have had shoulder surgery before.I have arthritis in my shoulder.The PI (person in charge of the study) thinks that your participation in the study may not be good for you or the goals of the study.The tear in your body is less than 1.5 centimeters in size.You have any implanted device that uses electrical stimulation, such as a cochlear implant or defibrillator.You have implanted devices that contain magnetic material.I have tested positive for HIV, Hepatitis B, Hepatitis C, HTLV-1, or HTLV-2.I am willing and able to follow post-surgery instructions and attend follow-up visits.I have diabetes.My teres minor muscle is affected.
Research Study Groups:
This trial has the following groups:- Group 1: Muscle Fiber Fragments (MFF)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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