Clinical Trial 51985

Richmond, VA 23219


This is a two-center, first-in-human prospective study of the immediate and long-term safety of the BioSphincter, an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat patients with severe passive FI who have failed standard therapies. The data will be analyzed to assess the safety of the treatment and the potential initial efficacy of the implanted BioSphincter in decreasing the number of episodes of incontinence in patients with severe FI.

The general investigational plan is to: 1) harvest and expand autologous smooth muscle and enteric neural progenitor cells (NPC); 2) bioengineer the intrinsic innervated IAS (BioSphincter); 3) implant the BioSphincter in subjects with severe passive FI that are unresponsive to standard treatments; and 4) determine the safety and assess initial efficacy potential of the BioSphincter by determining nature and frequency of adverse events, improvement in FI symptoms, quality of life, and physiological measures with anorectal manometry and endoscopic ultrasound at regular intervals after implantation.

The BioSphincter is an autologous, bioengineered, internal anal sphincter.


Briefly, the inclusion criteria are:

  • The patient has 4+ episodes of FI over a 2-week period that has lasted for at least 12 months.
  • The patient must have a resting pressure < or equal to 60 mmHg and presence of RAIR on manometry.
  • The patient must have failed all other approved treatments for FI (medical management: medications, biofeedback; surgical treatments: SNS).


The exclusion criteria include patients with active anorectal disease or infection, history of radiation, colorectal or anal cancer, IBD, neurologic impairment and severe cardiopulmonary or kidney disease.


Qualified Participants May Receive:

Suffering from Fecal Incontinence?
Fecal Incontinence (FI) is the inability to control your bowel movements, causing stool (feces) to leak unexpectedly from the rectum. It is a problem faced by about 1 in 12 adults in the US. FI affects all aspects of peoples’ lives, greatly reducing quality of physical and mental health.
For some patients, medical treatments have not allowed for sustained resolution of FI.

Cellf BIO provides a treatment that aims to restore the normal physiological function of the anorectum.
Innovative Cell-Based Therapy - BioSphincterTM
The BioSphincter is an autologous, bioengineered, internal anal sphincter. The experimental BioSphincter is bioengineered from your own smooth muscle cells and neural stem cells, retrieved in a biopsy procedure — eliminating any risk of rejection.
The newly grown autologous sphincter will be implanted in the area of the defective sphincter and will form a new continuum of the patient’s own gastrointestinal tract.

Frequently Asked Questions
1. What is a Clinical Trial?
A clinical trial is a research study conducted in human patients that evaluates an experimental medical, surgical, or behavioral intervention. This is one of the primary steps taken to find out new and better treatments — like a drug or device. A clinical trial assesses the effectiveness and side effects of the new treatment compared to the standard treatment.2
2. Am I eligible to participate?
To assess your eligibility yourself, ask these questions:
a. Do I have severe FI? (over a one-year period with four or more FI episodes in a two-week period.
b. Have I failed standard medical treatments?
If answered yes for both questions, contact our study staff and they will reach out with next steps.
3. What can I expect if I am eligible?
a. The duration of the study is three years after implantation at VCU Medical Center in Richmond, Virginia.
b. Compensation will be given to patients that complete the study.
c. There are two surgical procedures — two surgical biopsies performed at the same time and then surgical implantation of the BioSphincter.
4. How long will I be in this study?
The partcipant will receive the BioSphinctersTM in two surgical procedures over 6 to 8 weeks. After finish your study treatment, the study will continue to follow your condition and watch you for side effects. Study follow-up occurs over three years.
5. What medical records are needed to determine study eligibility?
a. Anorectal Manometry
b. Colonoscopy within the past five years
c. Records from your physician about the types of treatment which have been tried for fecal incontinence.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.