Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence
- Conditions
- Fecal Incontinence
- Interventions
- Biological: Bioengineered Internal Anal Sphincter
- Registration Number
- NCT05616208
- Lead Sponsor
- Cellf Bio LLC
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Implantation Bioengineered Internal Anal Sphincter This is a non-randomized, single group treatment study with a single arm and is not subject or investigator masked or blinded. BioSphincters will be implanted in every study subject.
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events of Implanted BioSphincter IAS for patients with severe FI Who Have Failed Standard Treatment 12-36 months 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 assessed postoperatively at postoperative Days 1, 3, 7, 14, 28, 42 (week 6) and 56 (week 8). Additional safety assessments will be made at medical visits on Weeks 12, 24, 36 and 48-post implantation. Final safety assessments will be made a.t the end of Years 2 and 3
- Secondary Outcome Measures
Name Time Method Initial efficacy of the implanted IAS in decreasing the number of episodes of fecal urgency in subjects with severe FI. 12-48 weeks Change in the number of episodes of fecal urgency within a two-week period of each follow-up visit (at 12, 24, 36, and 48 weeks after implantation) as recorded in subjects' bowel diaries.
Change from Baseline CCIS Score of the implanted IAS in improving quality of life 12-48 weeks Change in Cleveland Clinic Incontinence Score (CCIS) as evaluated at the time of each follow-up visit (at 12, 24, 36, and 48 weeks after implantation) and compared to baseline measures. Scored from 0 to 20 (0=complete continence, 20=complete incontinence)
Initial efficacy of the implanted IAS by conducting Anal Rectal Manometry (ARM) measuring IAS pressure to support measured clinical changes 0-36 months Measure of IAS pressure (mmHg) as evaluated at 12, 24, 36, and 48 weeks and at 2 and 3 years after implantation as compared with baseline measures and control subject normal values.
Initial efficacy of the implanted IAS by conducting Anal Rectal Manometry (ARM) measuring sensation of balloon distention pressure to support measured clinical changes 0-36 months Measure time to sensation of balloon distention (in seconds) as evaluated at 12, 24, 36, and 48 weeks and at 2 and 3 years after implantation as compared with baseline measures and control subject normal values.
Change from Baseline FIQOL Score of the implanted IAS in improving quality of life 12-48 weeks Change in Fecal Incontinence Quality of Life Scale (FIQOL) as evaluated at the time of each follow-up visit (at 12, 24, 36, and 48 weeks after implantation) and compared to baseline measures. Scales range from 1 to 5, with 1 indicating a lower functional quality-of-life status.
Initial efficacy of the implanted IAS by conducting Anal Rectal Manometry (ARM) measuring presence of RAIR to support measured clinical changes 0-36 months Measure presence or absence of RAIR as evaluated at 12, 24, 36, and 48 weeks and at 2 and 3 years after implantation as compared with baseline measures and control subject normal values.
Measure Physical characteristics of the Bioengineered Sphincter as assessed by endoscopic ultrasound (EUS) 0-36 months Measure physical characteristics of the thickness ( in mm) Bioengineered Sphincter as assessed by endoscopic ultrasound at 48 weeks, 2 years and 3 years.
Initial efficacy of the implanted IAS in decreasing the number of episodes of incontinence in subjects with severe FI. 12-48 weeks Change in the number of FI episodes within a two-week period of each follow-up visit (at 12, 24, 36, and 48 weeks after implantation) as recorded in subjects' bowel diaries.
Change from Baseline FISI Score of the implanted IAS in improving quality of life 12-48 weeks Change in Fecal Incontinence Severity Index (FISI) as evaluated at the time of each follow-up visit (at 12, 24, 36, and 48 weeks after implantation) and compared to baseline measures. 0 to 61, where the higher the score, the higher the perceived severity of the fecal incontinence.
Initial efficacy of the implanted IAS by conducting Anal Rectal Manometry (ARM) measuring EAS pressure to support measured clinical changes 0-36 months Measure EAS pressure in mmHg as evaluated at 12, 24, 36, and 48 weeks and at 2 and 3 years after implantation as compared with baseline measures and control subject normal values.
Trial Locations
- Locations (1)
Virginia Commonwealth University Health Main Hospital (VCU)
🇺🇸Richmond, Virginia, United States