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Bioengineered Implant
BioSphincter Implant for Bowel Incontinence
Phase 1
Recruiting
Led By Jaime Bohl, MD
Research Sponsored by Cellf Bio LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-36 months
Awards & highlights
Study Summary
This trial tests a new implant to help people with a severe form of fecal incontinence, who have not responded to other treatments.
Who is the study for?
Adults over 18 with severe passive fecal incontinence (FI) who've tried and failed all standard treatments, including dietary fiber, anti-diarrheal meds, biofeedback training, sacral nerve stimulation, and sphincteroplasty. Candidates must be able to understand the study and follow procedures. Women of childbearing age should use contraception.Check my eligibility
What is being tested?
The trial is testing a new treatment for bowel incontinence: an implanted Bioengineered Internal Anal Sphincter made from the patient's own cells. It's a Phase I study focused on safety over both short-term and long-term periods after implantation.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with surgical procedures such as pain at the implant site, infection risk, inflammation or rejection of the bioengineered tissue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events of Implanted BioSphincter IAS for patients with severe FI Who Have Failed Standard Treatment
Secondary outcome measures
Change from Baseline CCIS Score of the implanted IAS in improving quality of life
Change from Baseline FIQOL Score of the implanted IAS in improving quality of life
Change from Baseline FISI Score of the implanted IAS in improving quality of life
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ImplantationExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Cellf Bio LLCLead Sponsor
Jaime Bohl, MDPrincipal InvestigatorVirginia Commonwealth University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand and agree to follow the study's requirements.I have ongoing severe diarrhea that treatments haven't helped, causing incontinence.I need a wheelchair or similar device to move around.I have had pelvic radiation, rectal issues, or surgery in the past year, or I currently have a colostomy.I do not have current or past infections in my anal area.I have a tumor in my anus or rectum.I haven't had cancer or needed chemotherapy in the last 5 years.I have a nerve condition affecting my limbs or spinal cord.My heart condition does not severely limit my daily activities.I have an untreated infection in my reproductive or urinary system.I have active inflammation in my rectum.My inflammatory bowel disease is not under control.I need home oxygen due to unstable lung function.My vital signs are within normal ranges before surgery.I have a bleeding disorder that is being treated by a blood specialist.I am a man who can father children and will use effective birth control during the study.I have severe uncontrollable bowel movements and treatments haven't worked.I am at high risk for complications from a biopsy in my intestine.My doctor thinks I can take part in the study.Standard treatments for my fecal incontinence have not worked.I am using birth control pills or an IUD if I can have children.I am postmenopausal and not on hormonal treatments, confirmed by high FSH levels.I had a colonoscopy within the last 5 years showing no cancer or inflammation.I only experience uncontrollable passing of gas.My anorectal manometry test showed low internal anal sphincter pressure and a present RAIR.I have had surgery or disease in my rectal area that could complicate further surgery.I have had an organ transplant and take drugs to suppress my immune system.I have painful or bleeding problems in my anal area.I have a history of kidney problems.I am 18 years old or older.I cannot do all required study activities because of my health or mental condition.I have other health issues that could be causing my incontinence.I have existing pain in my anal or rectal area.I cannot or do not want to come back for all needed follow-up visits.
Research Study Groups:
This trial has the following groups:- Group 1: Implantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How deleterious is the procedure of Implantation for individuals?
"Implantation's safety rating is 1, as the current clinical trial data available only supports a limited understanding of it efficacy and security."
Answered by AI
How many participants can join this medical experiment?
"Indeed, the evidence on clinicaltrials.gov affirms that this medical study, first uploaded on November 2nd 2022 is still recruiting participants. They are looking for 10 patients to join from a single site."
Answered by AI
Are there any open vacancies for this research endeavor?
"According to information on clinicaltrials.gov, this research endeavour is currently enrolling participants and was posted for the first time on November 2nd 2022. It has been modified most recently as of November 16th 2022."
Answered by AI
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