NCT05616208

Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cellf Bio LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a two-center 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. The data will be analyzed to assess the safety of the treatment and the potential initial efficacy of the implanted BioSphincter(TM) in decreasing the number of episodes of incontinence in subjects with severe FI. After being informed of the risks, informed consent patients will undergo a biopsy procedure to collect tissue samples and will then undergo an implantation surgery of the bioengineered BioSphincter(TM). Patients will be followed for 36 months, post implantation.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
BIOLOGICAL	Bioengineered Internal Anal Sphincter	Autologous Bioengineered Internal Anal Sphincter

Timeline

• Start date: 2022-11-02
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2022-11-15
• Last updated: 2025-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study