Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05616208
The ClinicalTrials.gov registry entry for NCT05616208 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 335-participant average among 22 other Fecal Incontinence trials with a reported enrollment target (97% lower). The listed sponsor is Cellf Bio, which has 1 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
COMPLETED · Phase 1
-
Indiana University Gastrointestinal Motility Diagnosis Registry
RECRUITING
-
Mechanisms of Improving Fecal Continence Muscles Motor Function
RECRUITING · NA
-
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
RECRUITING · NA
-
Autologous Muscle Fiber Fragment Injections
RECRUITING · NA
-
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.