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.