# BioSphincter to Treat Fecal Incontinence. Phase 1/2 Clinical Trial. SBIR Phase IIB

> **NIH NIH R44** · CELLF-BIO INC · 2021 · $1,393,626

## Abstract

Project Summary/Abstract:
 Fecal incontinence (FI), the involuntary soiling of various amounts of liquid and solid stool, is often
devastating from a social, psychological, and hygiene perspective. Men and women suffer from FI equally with
a range of 2 - 6% in people aged 20 - 30 years. The prevalence increases to over 15% in people older than 70
years1. FI may result from an isolated or combined loss of smooth muscle function (IAS), skeletal muscle
function (EAS), anorectal sensory mechanisms or neural control.
 Treatment of FI is initially conservative with attempts to bulk the stool, adjust or stop drugs that cause
either diarrhea or constipation, and biofeedback2,3. While these conservative measures may improve the
severity of FI, additional therapies are needed for total symptom management. Injection of various biomaterials
to augment the internal anal sphincter has also been attempted4, but results have been variable and of limited
duration when effective. In the past, surgical attempts with anterior/posterior surgical repair have been tried
such as graciloplasty and sacral nerve stimulation5,6, but long-term results have been disappointing6.
 There is a critical need for new therapies to address FI, particularly for patients who have severe
passive incontinence and low IAS pressure. Regenerative medicine methods, wherein a new IAS
BioSphincter™ is bioengineered from the patient's own cells and implanted to restore the structure and
function of the IAS and treat FI, represents a rational and novel approach to this debilitating disease.
Regeneration and implantation of the IAS “BioSphincter™” can restore physiological function of the IAS,
improve or resolve FI, and improve quality of life. Following implantation in rodents, the engineered sphincters
became vascularized and maintained their phenotype and functionality7,8. Further in our large animal studies,
the developed IAS BioSphincter™ were validated to treat the FI and successfully restored anorectal
functionality in rabbit9,10 and non-human primates11. The IAS BioSphincter™ was developed in GLP condition
further scaled up for manufacturing following GMP guidelines and put together for FDA application. According
to NIDDK, NIH, one out of three people report to health care providers owing to fecal incontinence, therefore,
regeneration and implantation of the IAS “Biosphincter™” will benefit a large socially distressed segment of
population via restoration of physiological function of the IAS, resolve FI, and improving quality of life.
 The primary objectives of the phase I clinical trial study are to: 1) determine the safety of the implanted
bioengineered IAS in patients with severe FI and 2) to analyse the data in order to assess the initial efficacy
potentials of the implanted IAS in decreasing the number of episodes of incontinence in patients with severe
FI. This new innovative approach will provide the patients with a better quality of life, and reinstate continence,
by providing an ...

## Key facts

- **NIH application ID:** 10002239
- **Project number:** 5R44DK105593-06
- **Recipient organization:** CELLF-BIO INC
- **Principal Investigator:** KHALIL N BITAR
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,393,626
- **Award type:** 5
- **Project period:** 2015-09-23 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10002239

## Citation

> US National Institutes of Health, RePORTER application 10002239, BioSphincter to Treat Fecal Incontinence. Phase 1/2 Clinical Trial. SBIR Phase IIB (5R44DK105593-06). Retrieved via AI Analytics 2026-07-20 from https://api.ai-analytics.org/grant/nih/10002239. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*