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).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.