Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-01 @ 1:59 PM
Study NCT ID:
NCT05396456
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2022-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Muscle Fiber Fragment Injections
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Autologous Muscle Fiber Fragment Injections for the Treatment of Fecal Incontinence
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: