NCT05396456

Autologous Muscle Fiber Fragment Injections

Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The Study hypothesizes that efficient re-assembly of injected fragments within host muscle tissue along the fiber direction of native muscle will be induced. It is anticipated that these fiber fragments would integrate into the host vascular and neural network.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
PROCEDURE	Muscle Fiber Fragment (MFF) Injections	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.

Timeline

• Start date: 2023-01-12
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2022-05-31
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States