Muscle Fiber Fragment Injections for Bowel Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to regenerate damaged anal sphincter muscles using small pieces of muscle that contain special cells. These pieces are injected into the damaged area to grow new muscle and restore function by connecting with the body's blood vessels and nerves.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you require immunosuppression or have certain health conditions, you may not be eligible to participate.
Is Muscle Fiber Fragment Injection safe for humans?
How is the treatment of Autologous Muscle Fiber Fragment Injections for bowel incontinence different from other treatments?
This treatment is unique because it involves injecting a patient's own muscle fibers into the anal sphincter to help repair and strengthen it, which is different from traditional treatments that may not use the body's own cells. This approach aims to improve muscle function and continence by promoting muscle regeneration directly at the site of damage.12678
What data supports the effectiveness of the treatment Autologous Muscle Fiber Fragment Injections for Bowel Incontinence?
Who Is on the Research Team?
Catherine Matthews, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for adults with bowel incontinence lasting over a year, who've tried other treatments without success. They must have an anal sphincter defect and frequent incontinence episodes. Women should use birth control during the study. Excluded are those with bleeding disorders, rectal pain or diseases, recent cancer, certain infections like HIV/Hepatitis B/C, severe heart/lung/kidney conditions, uncontrolled diabetes, or recent childbirth.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive autologous muscle fiber fragment injections for the treatment of fecal incontinence
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Muscle Fiber Fragment Injections
Autologous Muscle Fiber Fragment Injections is already approved in United States, European Union for the following indications:
- Urinary incontinence due to sphincter insufficiency
- Anal sphincter muscle regeneration
- Urinary incontinence due to sphincter insufficiency
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor