Cellf Bio has reported the first human implantation of its bioengineered sphincter, BioSphincter, in a Phase I clinical trial in patients with fecal incontinence (FI).
BioSphincter is made of smooth muscle and differentiated neural stem cells made from the patient’s own cells taken from an intestinal biopsy and cultured in the laboratory.
Once the cells are ready, they are bioengineered into a ring and implanted into the patient’s anal sphincter, where it begins to function as a normal internal anal sphincter.
“The transplant was successful and the patient is doing well. This is a major step forward in the development of BioSphincter as a potential treatment for FI,” said Dr. Khalil N. Bitar, Cellf Bio CEO. .
The implant will be marketed to patients with FI who have not responded to other treatments.
Clinical trials for implants Currently recruitingis funded by a grant from the National Institutes of Health (NIH).
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The Phase I clinical trial aims to collect implant safety data and evaluate the effectiveness of the implant in reducing the frequency of incontinence in patients with severe FI.
Current treatments for FI are symptomatic, with biofeedback therapy and sacral nerve stimulation only used in severe cases of FI.
by International Digestive Disease Foundation (IFFGD), the combined incidence of FI and urinary incontinence is estimated to be approximately 10% of the total population. However, IFFGD says FI is often underreported.
The Virginia, US-based company is reportedly raising funding to support its next steps in commercialization.