RECRUITING

Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this study, a chest muscle sample (biopsy) will be taken and the muscle fibers will be removed from the sample and made into smaller strands or fragments. During this same procedure, those muscle fiber fragments (MFFs) will then be injected directly into the supraspinatus muscle. Once injected, the MFFs will remain in the supraspinatus where Investigators believe the MFF will become part of the participants' existing muscle and provide increased muscle size and strength, improving function (rotator cuff strength and stability).

Official Title

Safety of Autologous Muscle Fiber Fragments for Improved Function of Rotator Cuff Musculature Following Rotator Cuff Repair

Quick Facts

Study Start:2019-11-04
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03752034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females, ages 40 to 80 years
  2. * Unilateral Disease
  3. * \< 1.5cm tear
  1. * Diabetes
  2. * Peripheral Neuropathy
  3. * Previous Shoulder Surgery
  4. * Pain Syndrome; cuff arthroplasty
  5. * Major co-morbidities including, but not limited to, uncontrolled diabetes, cardiovascular, pulmonary, GI, coagulopathies
  6. * Arthritis of Shoulder
  7. * Unwilling or unable to comply with post-operative instructions or follow-up visits
  8. * Auto Immune Disease
  9. * Complete Subscapularis Tear
  10. * Teres Minor involvement
  11. * History of testing positive for HIV, Hep B, Hep C, HTLV-1, HTLV-2
  12. * Pregnancy
  13. * Implanted devices containing ferromagnetic material
  14. * Any implanted electrical stimulation devices (i.e. cochlear implant, defibrillator)
  15. * Any other condition which the PI feels would be not in the best interest for the patient or the study

Contacts and Locations

Study Contact

Mary-Clare Day, RN
CONTACT
336-713-1343
mday@wakehealth.edu

Principal Investigator

Gary G Poehling, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Gary G Poehling, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-11-04
Study Completion Date2025-12

Study Record Updates

Study Start Date2019-11-04
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Muscle Fiber Fragments
  • Rotator Cuff Musculature
  • Rotator Cuff Repair

Additional Relevant MeSH Terms

  • Rotator Cuff