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

RICHMOND, Va., Jan. 05, 2023 (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

Cellf BIO to Hold Meetings During J.P. Morgan Health Conference Week 2023

During the conference event period, the Company will hold one-on-one meetings with registered investors and pharmaceutical companies to introduce Cellf BIO and explore potential opportunities of investment, licensing deals, and co-development for the Company's main pipeline assets. 

About Cellf BIO

Cellf BIO is a biomedical technology company that specializes in the manufacturing of bioengineered sphincters using autologous progenitor cells. Its vision is to improve the quality of life for patients suffering from fecal incontinence, gastroesophageal reflux disorder, and other neuro-gastroenterological disorders. Cellf BIO's in-house production is located at the VA Bio + Tech Park in Richmond, VA. Cellf BIO has been awarded a grant from the NIH for this clinical trial. To learn more about Cellf BIO, visit: http://www.cellfbio.com/ or visit us on LinkedIn.

CSSi LifeSciences, the CRO helping Cellf BIO, files its IND

CSSi LifeSciences is a global contract service provider whose mission is to successfully advance drugs and medical device technologies from discovery to commercialization. CSSi LifeSciences provides customized solutions to propel life science technologies to market by mitigating risks, time, and cost, while increasing its chances of success. CSSi LifeSciences provides services across all phases of drug and medical device development, in the United States and abroad. For more information, visit: www.cssilifesciences.com.


For partnership, co-development, or collaboration opportunities with Cellf BIO, contact:

Rayana Marker, MSE, MBA
Chief Operating Officer, Cellf BIO

Media Contact

Jim Sergi
President, CSSi LifeSciences

Cellf BIO’s clinical trial is supported by NIDDK of the National Institutes of Health under award number R44DK105593. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.