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

Conditions

• Rotator Cuff

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Muscle Fiber Fragments (MFFs) — OTHER
  During the rotator cuff repair procedure, a biopsy of muscle will be taken from the pectoralis major and processed under sterile conditions in the operating room to obtain MFFs. The final product, composed of autologous MFFs in suspension, will be delivered via targeted injection into the muscle belly of the supraspinatus through the Naviaser Portal with visual guidance after rotator cuff repair is complete.

Study Details

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).

Key Dates

Start date

Nov 4, 2019

Status verified

Mar 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Muscle Fiber Fragments (MFF)
  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.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: 6 months post surgery ]

Central Contacts

• Mary-Clare Day, RN
  336-713-1343
  [email protected]

Locations (1)

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