Cellf Bio has reported the first human implantation of its autologous bioengineered sphincter BioSphincter in a Phase I clinical trial for patients with faecal incontinence (FI).
BioSphincter is made of smooth muscle and differentiated neural stem cells made from the patient’s own cells, which are harvested from intestinal biopsies and then cultured in a laboratory.
Once the cells are ready, they are bioengineered into rings and implanted into the patient’s anal sphincter, where they begin to function as a normal internal anal sphincter.
“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,” said Cellf Bio CEO Dr Khalil N. Bitar.
The implant will be marketed for FI sufferers who are not responding to other treatments.
The clinical trial for the implant is currently recruiting, and is funded by a grant from the National Institutes of Health (NIH).
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The Phase I clinical trial is designed to collect the safety data of the implant, and to evaluate efficacy of the implant in decreasing the number of episodes of incontinence in patients with severe FI.
The current treatment for FI is symptomatic treatment, with Biofeedback therapy and sacral nerve stimulation reserved for severe cases of FI.
According to the International Foundation for Gastrointestinal Disorders (IFFGD), the combined incidence rate of FI and urinary incontinence is estimated to be about 10 percent in the total population. However, IFFGD states that FI is often under reported.
The Virginia, US-based company is reportedly raising capital to support its next steps in commercialisation.