DOI: 10.1093/dote/doad052.095 ISSN:

253. ESOPHAGEAL REGENERATION FOLLOWING IMPLANTATION OF A TISSUE ENGINEERED ESOPHAGEAL IMPLANT: UNDERSTANDING THE REGENERATION TIME COURSE AND TRANSLATION TO THE CLINIC

William Fodor
  • Gastroenterology
  • General Medicine

Abstract

Diseases of the esophagus, damage of the esophagus due to injury or congenital defects during fetal esophageal development, i.e., Esophageal Atresia (EA), typically require surgical intervention to restore esophageal continuity. The development of novel tissue engineered tubular structures would improve the treatment options for these conditions by providing an alternative that is organ sparing and can be manufactured to fit the exact dimensions of the defect. Biostage has developed an autologous tissue engineered Esophageal Implant, composed of an electrospun cellular scaffold seeded with autologous mesenchymal stromal cells, that can stimulate repair and regeneration of segmental defects in the esophagus following surgical implantation. Biostage has received approval from the FDA on an Investigational New Drg (IND) application for a clinical trial in adults requiring esophageal reconstruction. A discussion of the regeneration time course, in adults and in a pediatric model as well as the critical features of the IND, the Regulatory process for treating adults with the intention to treat Esophageal Atresia and the clinical study parameters highlight the novelty of this tissue engineered combination product.

More from our Archive