Small Bowel Replacement and Regeneration16th Dec 2014

Case Study: Tahera Ansari, Northwick Park Institute for Medical Research

Small Bowel Replacement and Regeneration

Bowel disease leading to nutrient absorptive failure is a significant clinical issue, ultimately leading to shortened life expectancy, poor quality of life and reliance on chronic care regimes with major comorbidities and significant impact on NHS finances.

This project aims to develop a product to replace diseased small bowel tissue and restore normal function through the combination of decellularised porcine bowel with mesenchymal stem cells. The aim is to avoid the ATMP regulations by seeding acellular bowel scaffold grafts at the time of implantation into the patient. Autologous mesenchymal stem cells would be prepared with minimal manipulation and then reseeded on to the scaffold and use the patient as the ‘bioreactor’.

Essentially, the strategy is to grow the organ in the body until differentiated/regenerated enough to be surgically placed ‘online’ with a second surgical procedure.

The main outcome of the project will be 1) the degree of scaffold and vasculature priming/seeding achieved prior to in vivo implantation, and 2) the development of an implantation model translatable to first in man clinical phase. [For human implantation either a human small bowel scaffold (allogeneic; of cadaveric origin) or a porcine derived scaffold will be used in combination with human autologous cells.]

Whilst it is recognised that in the preclinical animal models using a porcine scaffold in a porcine implantation model is an allogeneic use compared to the proposed clinical use of a xenogeneic porcine scaffold into a patient; the porcine bowel large animal model remains the best representation of the human condition and surgery.

Previous work in this lab and others, has demonstrated that data generated from acellular porcine scaffolds implanted allogeneically into porcine models is translated into human clinical safety and performance. Therefore, the current proposal of using an allogeneic implantation model with autologous cells is warranted. Taken together, this data will be pivotal to raise additional private investment to commercialise the technology.

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