News

CELLF BIO Achieves Milestone With First In Human Implantation of BioSphincter™

CELLF BIO achieved a major milestone with the world’s first human implantation of BioSphincter™, an autologous bioengineered sphincter made of smooth muscle and differentiated neural stem cells. The Phase 1 clinical trial is being conducted to treat patients with fecal incontinence (FI), a condition that affects millions of people worldwide. The implantation surgery was performed by Dr. Jaime Bohl, chief of colon and rectal surgery at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

“We are very pleased with the progress of the clinical trial thus far,” said CELLF BIO CEO Dr. Khalil N. Bitar, PhD, AGAF. “The implantation was successfully completed and the patient is doing well. This is a major step forward in the development of BioSphincter™ as a potential treatment for FI.”

FI is a debilitating condition that can cause great embarrassment and social isolation. Current treatments for FI are often ineffective and can have serious side effects. BioSphincter™ offers a potential solution for FI sufferers who have not responded to other treatments.

The BioSphincter™ is made from the patient’s own cells, which are harvested from intestinal biopsies and then cultured in the laboratory. Once the cells are ready, they are bioengineered into rings and implanted into the patient’s anal sphincter, where they will begin to function as a normal internal Anal Sphincter.

The clinical trial is expected to continue for several more months, and CELLF BIO is hopeful that BioSphincter will ultimately be approved for use in patients with FI in the future.

“If successful, BioSphincter could provide a much-needed treatment option for patients with FI,” said Dr. Bitar. “We are committed to continuing the development of this potentially life-changing therapy.”

The BioSphincter™ clinical trial is currently funded by a grant from NIH and the company is looking to raise capital to support next steps in commercialization.

Learn more here.

Recent News

07/19/2024

Capra Biosciences Lands $7.5 Million Project Agreement To Demonstrate Platform To Rapidly Scale Pharmaceutical Ingredient Manufacturing

Many ingredients that make up the pharmaceuticals Americans rely on are manufactured overseas. When supply chain issues or shortages occur, as witnessed during the COVID pandemic, it can negatively impact millions of Americans and affect national security. The White House issued an Executive Order in 2022 to stimulate U.S. biomanufacturing. Increasing American biomanufacturing, will provide

07/15/2024

Lupus Treatment with Omega3-Rich Krill Oil Improves Disease Activity

AMPEL BioSolutions, with collaborators Lupus Therapeutics and Aker Biomarine, revealed peer-reviewed results that supplementation with Omega3-rich Krill Oil improves disease activity of autoimmune Lupus patients. Omega3 lipids called polyunsaturated fatty acids (PUFAs) that are found in microscopic shrimp-like crustaceans called Krill from the waters around Antarctica are key to maintaining a low inflammatory state.  Some

07/15/2024

Inorganic Ventures acquires PURE Analytical Laboratories, Combining Unique Capabilities for Precision Manufacturing

Two privately held specialty chemical firms that provide high-purity materials and services for chemical applications, from renewable energy to food and beverages and consumer safety, are combining their capabilities to serve new and expanding precision markets. IV Labs Inc., the parent company of Inorganic Ventures, has acquired PURE Analytical Laboratories, one of the few companies that