BioSphincter Implant for Bowel Incontinence

Overseen By Jin or Shannon clinical research coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cellf Bio LLC

Must not be taking: Immunosuppressants, Chemotherapy

Disqualifiers: Anorectal disease, IBD, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on anticoagulation therapy, it may need to be temporarily halted with permission from your prescribing provider for elective surgery.

How is the BioSphincter treatment for bowel incontinence different from other treatments?

The BioSphincter treatment is unique because it involves implanting a bioengineered internal anal sphincter that is intrinsically innervated, meaning it has its own nerve supply, which helps restore normal muscle function and pressure in the anal canal. This regenerative approach aims to provide a long-term solution by integrating with the body's tissues, unlike artificial sphincters that may face compatibility issues. ^{1 2 3 4 5}

What data supports the effectiveness of the BioSphincter Implant treatment for bowel incontinence?

Research in animal models shows that the BioSphincter Implant can restore bowel control by improving muscle function and pressure in the anal area. In a study with rabbits, those treated with the implant regained normal muscle tone and reflexes, which are important for controlling bowel movements, compared to untreated animals. ^{1 3 5 6 7}

Who Is on the Research Team?

Jaime Bohl, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I understand and agree to follow the study's requirements.

My vital signs are within normal ranges before surgery.

I am a man who can father children and will use effective birth control during the study.

Exclusion Criteria

Concurrent participation in any other clinical investigation during the period of this investigation

I have ongoing severe diarrhea that treatments haven't helped, causing incontinence.

I need a wheelchair or similar device to move around.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy and Implantation

Participants undergo a biopsy procedure to collect tissue samples followed by implantation surgery of the bioengineered BioSphincter(TM)

8 weeks

Inpatient hospital follow-up and outpatient clinic visits at Days 1, 3, 7, 14, 28, 42, and 56

Initial Follow-up

Participants are monitored for safety and initial efficacy of the implanted BioSphincter(TM) with assessments at predefined intervals

48 weeks

Medical visits at Weeks 12, 24, 36, and 48

Long-term Follow-up

Participants are monitored for long-term safety and efficacy of the implanted BioSphincter(TM)

36 months

Final safety assessments at the end of Years 2 and 3

What Are the Treatments Tested in This Trial?

Interventions

• Bioengineered Internal Anal Sphincter

Trial Overview 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.

How Is the Trial Designed?

Group I: Implantation Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Cellf Bio LLC

Lead Sponsor

Trials

1

Recruited

10+

Published Research Related to This Trial

Bioengineered human internal anal sphincter (IAS) tissue constructs were successfully implanted in athymic rats, showing good tolerance and no early postoperative complications, indicating their potential safety for future applications.

The implanted constructs demonstrated healthy integration with surrounding tissue, maintained their contractile function, and responded to neuronal stimulation, suggesting they could effectively restore IAS function and help treat fecal incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perianal implantation of bioengineered human internal anal sphincter constructs intrinsically innervated with human neural progenitor cells. Raghavan, S., Miyasaka, EA., Gilmont, RR., et al.[2021]

Three-dimensional bioengineered constructs of the internal anal sphincter (IAS) can be successfully implanted in mice without rejection or inflammation, indicating their potential safety for future applications in humans.

The infusion of fibroblastic growth factor 2 significantly enhanced muscle viability and vascularity of the implanted constructs, suggesting that this treatment could improve outcomes for patients suffering from fecal incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical implantation of a bioengineered internal anal sphincter. Hashish, M., Raghavan, S., Somara, S., et al.[2021]

In a study of 82 patients with severe fecal incontinence, the injection of silicone biomaterial (PTP) significantly improved fecal continence and quality of life, with effects lasting up to 12 months, especially in patients whose injections were guided by endoanal ultrasound.

There were no significant complications from the procedure, and the ultrasound confirmed that the silicone material remained in place without migration, indicating a safe and effective treatment option for internal anal sphincter dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable silicone biomaterial for fecal incontinence caused by internal anal sphincter dysfunction is effective. Tjandra, JJ., Lim, JF., Hiscock, R., et al.[2005]

In a study involving 20 female rabbits, implantation of engineered autologous internal anal sphincter (IAS) biosphincters successfully restored fecal continence, as shown by improved anal pressure and reflexes measured through anorectal manometry over a 3-month period.

The treated rabbits demonstrated significant restoration of anal function compared to non-treated and sham groups, indicating that this approach could be a promising new treatment for fecal incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Passive Fecal Incontinence in an Animal Model Using Engineered Biosphincters: A 3-Month Follow-Up Study. Bohl, JL., Zakhem, E., Bitar, KN.[2019]

The study tested three growth factors (FGF-2, VEGF, and PDGF) in bioengineered internal anal sphincter (IAS) implants in mice, showing that all growth factors helped maintain smooth muscle phenotype and improved tissue characteristics compared to controls.

Among the growth factors, PDGF showed particularly promising results and is already approved for clinical use, making it a strong candidate for future clinical applications of bioengineered IAS implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo growth of a bioengineered internal anal sphincter: comparison of growth factors for optimization of growth and survival. Miyasaka, EA., Raghavan, S., Gilmont, RR., et al.[2021]

The implantation of bioengineered IAS BioSphincters in a Non-Human Primate model of passive fecal incontinence successfully restored anal resting pressure and recto-anal inhibitory reflex within one month, with effects sustained for up to 12 months.

Histological studies confirmed the safety and biocompatibility of the implants, showing no adverse effects and regeneration of healthy nerve and muscle tissue, suggesting this approach could significantly improve the quality of life for patients with fecal incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BioSphincters to treat Fecal Incontinence in Nonhuman Primates. Dadhich, P., Bohl, JL., Tamburrini, R., et al.[2023]

The Acticon Neosphincter, the only FDA-certified artificial anal sphincter, shows promise as a treatment for severe fecal incontinence, addressing both physical and psychological impacts on patients.

A major challenge with artificial sphincters is maintaining long-term compatibility with surrounding tissues, which can be improved by using smart materials to enhance biomechanical integration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges faced in the clinical application of artificial anal sphincters. Wang, MH., Zhou, Y., Zhao, S., et al.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Perianal implantation of bioengineered human internal anal sphincter constructs intrinsically innervated with human neural progenitor cells. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Surgical implantation of a bioengineered internal anal sphincter. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Injectable silicone biomaterial for fecal incontinence caused by internal anal sphincter dysfunction is effective. [2005]

4. England pubmed.ncbi.nlm.nih.gov

Successful Treatment of Passive Fecal Incontinence in an Animal Model Using Engineered Biosphincters: A 3-Month Follow-Up Study. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

In vivo growth of a bioengineered internal anal sphincter: comparison of growth factors for optimization of growth and survival. [2021]

6. England pubmed.ncbi.nlm.nih.gov

BioSphincters to treat Fecal Incontinence in Nonhuman Primates. [2023]

7. China pubmed.ncbi.nlm.nih.gov

Challenges faced in the clinical application of artificial anal sphincters. [2018]