BioSphincter a Regenerative Medicine Approach to Treat FI

Abstract

A healthy sphincter physiology is a complex interplay between neural and muscle population, responsible for relaxation and contraction, which allow feces to pass and reestablishment of closure. The loss of integrity of neuromuscular functionality or cellular component results in fecal incontinence (FI). The current available treatments have been disappointing in long-term relief. This chapter represents a regenerative medicine approach to this debilitating disease, wherein a new internal anal sphincter (IAS) BioSphincter ™ is bioengineered from the patient ’ s own cells and implanted. It results in long-term restoration of the cellular integrity and reinstatement of the physiological function of the IAS. Following implantation in rodents, the engineered sphincters became vascularized and maintained their phenotype and functionality. The developed IAS BioSphincter ™ were validated to treat the FI in large animals and successfully restored anorectal functionality. According to NIH/NIDDK, one out of seven people report to health care providers complaining of fecal incontinence. This chapter elucidates the long road in developing on implantable bioengineered IAS “ BioSphincter ™ ” that would benefit and improve the quality of life of a large socially distressed segment of the population.