Autologous Muscle Fiber Fragment Injections

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05396456
Status
Recruiting
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Conditions

  • Fecal Incontinence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Muscle Fiber Fragment (MFF) Injections — PROCEDURE
    The participant will be treated with an injection of muscle fiber fragments into the external anal sphincter at 3, 6, 9 and 12 o'clock using a 21-gauge needle to a depth of 1-2 cm from the external skin using equal amounts in each quadrant.

Study Details

To regenerate functional anal sphincter muscle using muscle fiber fragments that contain muscle precursor cells (MPCs)

Key Dates

Start date
Jan 12, 2023
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Muscle Fiber Fragment (MFF) injections
    autologous muscle fiber fragment injections, harvested in an autologous fashion from the quadriceps muscle, for the treatment of Fecal Incontinence (FI) symptoms in men and women with a demonstrated anal sphincter defect and who have failed conservative treatments

Primary Outcome Measure

Cleveland Clinic Fecal Incontinence Severity Scoring System (CCIS) scores (also termed the Wexner score) [ Time Frame: Month 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Mary-Clare Day, RN, BSN
[email protected]
336-713-1343

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By research site
Wake Forest University Health Sciences· Winston-Salem, NC

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