Cellf BIO Begins Phase 1 Clinical Trial of BioSphincter™ Implant for Fecal Incontinence

RICHMOND, Va., (GLOBE NEWSWIRE) — Cellf BIO, a biotechnology company that manufactures bioengineered sphincters using autologous progenitor cells, announced today that it has begun its Phase 1 clinical trial for its BioSphincter™ Implant for the treatment of severe passive fecal incontinence (FI). The FDA cleared the company’s Investigational New Drug (IND) application, and the Institutional Review Board (IRB) approved the trial to begin enrolling participants.

The clinical trial is a two-center, first-in-human, prospective Phase 1 study of the immediate and long-term safety of the BioSphincter™ implant. The trial is designed to treat patients with severe passive fecal incontinence who have failed standard treatments. The trial will assess the safety of the treatment and the potential initial efficacy of the BioSphincter™ in reducing the number of incontinence episodes in patients with severe fecal incontinence.

“We are excited to begin this clinical trial for the BioSphincter™,” said Khalil N Bitar, Founder and CEO of Cellf BIO. “The BioSphincter™ has the potential to greatly improve the quality of life for these patients.”

Cellf BIO’s patented technologies focus on the use of autologous stem cells to provide patients with specialized medical approaches and relief from neurodegenerative gastrointestinal ailments and symptoms. The BioSphincter™ has several potential benefits, including no risk of rejection due to the use of the patient’s own cells, no need for replacement parts or additional surgeries, and no pre-testing period like stimulation devices. The BioSphincter™ has the potential to restore neurological connections and physiological function, and the company holds a strong intellectual property position through its patent protections.

To learn more about the trial and to find out if you or a loved one may be eligible to participate, visit the clinicaltrials.gov study page here: https://clinicaltrials.gov/ct2/show/NCT05616208

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