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Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence

NCT05616208 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-09

No results posted yet for this study

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.

Conditions

  • Fecal Incontinence

Interventions

BIOLOGICAL

Bioengineered Internal Anal Sphincter

Autologous Bioengineered Internal Anal Sphincter

Sponsors & Collaborators

  • Cellf Bio LLC

    lead INDUSTRY

Principal Investigators

  • Jaime Bohl, MD · Virginia Commonwealth University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-02
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05616208 on ClinicalTrials.gov