Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence (NCT05616208)
Phase 1 Treatment Study to Assess Safety and Proof of Concept to Assess Potential Efficacy of the Implanted Internal Anal Sphincter BioSphincterTM Bioengineered From Autologous Cells to Treat Patients With Severe Passive Fecal Incontinence
🩺 Plain-English Summary (8th-Grade Level)
This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed standard treatments.
Who can join: Review the eligibility criteria below.
Location: Virginia Commonwealth University Health Main Hospital (VCU) — Richmond, Virginia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Virginia Commonwealth University Health Main Hospital (VCU) — Richmond, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Fecal Incontinence
- Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury — La Jolla, California
- Use of the LEVA® Pelvic Health System for Fecal Incontinence — Madison, Wisconsin
- Autologous Muscle Fiber Fragment Injections — Winston-Salem, North Carolina
- Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury — Cleveland, Ohio
- Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence — Augusta, Georgia
Explore by condition: All Fecal Incontinence clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.