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NCT05616208 · ClinicalTrials.gov registry record · Phase 1
Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence
A Phase 1 study of Fecal Incontinence, sponsored by Cellf Bio.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05616208: Active Phase 1 study of Fecal Incontinence, sponsored by Cellf Bio.
NCT05616208 is a Phase 1 study of Fecal Incontinence that is active but no longer recruiting, run by Cellf Bio. The registered enrollment target is 10 participants, below the 335-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05616208, a Phase 1 study of Fecal Incontinence, is active but no longer recruiting, sponsored by Cellf Bio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
To determine the safety of IAS cell harvest and the implanted BioSphincter IAS in subjects with severe FI. Occurrence of adverse events. * Occurrence, severity, duration, and relationship to study procedures. * The safety of all surgical and diagnostic procedures will be assessed at inpatient hospital follow-up and outpatient clinic visits at predefined intervals. * Biopsy: Site of IAS cell harvest will be assessed postoperatively at Days 1, 7, and 21. * BioSphincter implantation will be a
Conditions Studied
Interventions
- BIOLOGICAL Bioengineered Internal Anal Sphincter
Study Locations (1)
Virginia
- Virginia Commonwealth University Health Main Hospital (VCU) - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-11-02 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What the registry record for NCT05616208 still lists
NCT05616208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 335-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Fecal Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Bioengineered Internal Anal Sphincter is the first listed.
NCT05616208 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05616208 about?
NCT05616208 is a clinical study titled "Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence". 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.
What is the current status of trial NCT05616208?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2022-11-02. Estimated completion is 2027-07.
What conditions does trial NCT05616208 study?
This clinical trial studies the following conditions: Fecal Incontinence.
What interventions are being tested in trial NCT05616208?
The interventions under investigation include: Bioengineered Internal Anal Sphincter (BIOLOGICAL).
Who is sponsoring clinical trial NCT05616208?
This trial is sponsored by Cellf Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05616208 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fecal Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05616208's enrollment target sits among peer trials
10 19th of 22 higher than 2 of 22 other Fecal Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fecal Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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