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BioSphincters to treat Fecal Incontinence in Nonhuman Primates.

Prabhash Dadhich1,2, Jaime L Bohl3, Riccardo Tamburrini3

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Bioengineered internal anal sphincters (IAS) effectively treated fecal incontinence (FI) in a primate model. This regenerative therapy restored anal pressure and function, offering a promising solution for patients with FI.

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Area of Science:

  • Regenerative Medicine
  • Gastroenterology
  • Biomedical Engineering

Background:

  • Internal anal sphincter (IAS) dysfunction causes fecal incontinence (FI).
  • Current treatments for passive FI have limitations.
  • A need exists for effective regenerative therapies for FI.

Purpose of the Study:

  • To evaluate the safety and efficacy of bioengineered IAS BioSphincters for treating passive fecal incontinence.
  • To assess the long-term outcomes of this regenerative approach in a large animal model.

Main Methods:

  • Developed a Non-Human Primate (NHP) model of passive fecal incontinence.
  • Implanted autologous, intrinsically innervated IAS BioSphincters.
  • Monitored fecal soiling, anorectal resting pressure, and Recto Anal Inhibitory Reflex (RAIR) manometrically.
  • Conducted histological and pathological assessments of implants and organs.

Main Results:

  • Implantation of IAS BioSphincters resolved fecal soiling and restored resting pressure and RAIR within 1 month.
  • Efficacy was sustained for up to 12 months post-implantation.
  • Histology confirmed regeneration of a well-organized neuro-muscular population in the IAS.
  • Control groups showed persistent FI symptoms.
  • Pathological assessments confirmed implant biocompatibility and absence of adverse effects.

Conclusions:

  • Bioengineered IAS BioSphincters represent a safe and effective regenerative treatment for passive fecal incontinence.
  • This approach shows potential for significant improvement in patients' quality of life.
  • Intrinsically innervated constructs offer a promising therapeutic strategy for restoring anal sphincter function.