Development of a human pancreatic islet-transplant program through a collaborative relationship with a remote islet-isolation center.

BACKGROUND

With the development of the Edmonton Protocol, pancreatic islet transplantation (PIT) now offers insulin-dependent diabetic patients metabolic stability. The PIT Food and Drug Administration (FDA) regulations, pancreatic islet isolation (PII) techniques, and clinical PIT protocols are challenging and make PIT program development daunting.

PURPOSE

Review of the establishment of a PIT program through a collaborative relationship with a remote PIT/PII center.

METHODS

Four key elements are required: (1) development of a collaborative relationship with an established PIT/PII center, (2) achievement of institutional review board and FDA approval at both centers, (3) generation of standard operating procedures, and (4) development of a multidisciplinary PIT team.

RESULTS

Securing a collaborative relationship with an experienced PIT/PII center permitted our program to develop in less than 18 months. Twenty-two PITs were completed in the first clinical year.

CONCLUSIONS

Collaboration with an experienced PIT/PII center allows developing programs to focus on patient safety and care, prudent use of pancreata, and consolidates PII expertise and experience.