Developin Good Manufacturing Practice (GMP) compliant Protocols for Porcine Islets

Dr. Greg Korbutt

Greg KorbuttAdvances in transplantation of human islets have established the proof-of-concept for this therapy to emerge as a treatment for patients with Type 1 diabetes. Despite efforts to maximize organ donation the number of human islets available for transplantation continues to limit the number of patients who can be transplanted. One approach to address this rate-limiting problem is to use islets from an animal source such as pigs. This proposal seeks to advance the possibility of pig islet transplantation, since: 

1) Porcine insulin has been used to treat diabetes for more than 60 years 

2) Porcine islets respond to glucose in the same manner as do human islets 

3) Pigs breed rapidly and produce large litters, providing a virtually unlimited source of islets 

4) We have shown that Neonatal Porcine Islets (NPIs) are able to correct diabetes in the preclinical non-human primate model

 

We believe that in the near future NPIs will be used for clinical transplantation for patients with type 1 diabetes and thereby solve the shortage of insulin-producing tissue. Principal challenges that must be met to make transplantation of NPIs a clinical reality include: 

1) Defining a reproducible strategy for isolating large numbers of clinical grade NPIs 

2) Developing a means of transplanting NPIs without the need for life-long anti-rejection drugs.