International Multicenter Trial

A microscopic image of an Islets, regions of the pancreas that contain hormone-producing cells.

Kovler is extremely happy to announce that the Section of Endocrinology has just officially become active as the only US site for the new International Multicenter Trial testing a new anti-inflammatory approach in Pancreatic Islet Transplantation for “brittle” T1D patients! We received IRB approval last week, the FDA has approved the IND and a contract has been signed with the sponsor.

Based on our records, we were distinguished as one of the best and most promising Islet Cell Transplant centers in the USA. This is a big recognition for our Program and our University. It also provides opportunity for substantial funding for the entire institution, including the CCD Hospital, where patients will stay for 7 days after the transplant.

Over the last 8 years our Islet Cell Transplant program has helped many patients achieve better glucose control and improved quality of life. Our first patient continues to be insulin independent for more than 7 years post transplant. None of this would have been possible without tremendous help and engagement of Lou Philipson, Silvana Pannain, Suma Dronavalli and recently Colleen Flynn.

For the last few years, we have been able to provide more effective immunosuppressive regimens than those used in the Edmonton protocol. This has allowed us to provide a 40-50% insulin independence rate 5 years after transplant, which is comparable to pancreas transplant alone while avoiding the risks of surgical complications.

At this time, in the new multicenter study, we will be able to test the influence of a new anti-inflammatory agent (anti-IL 8 ) to further improve results.

Therefore, we are now actively recruiting patients for our new study. Currently, we are looking for the help of the endocrine community to offer patients the ability to participate in this exciting opportunity while the funding is still available (competitive enrollment among the sites of the trial). The study is designed for highly selected adult type I diabetic patients, who experience severe hypoglycemic episodes despite optimal insulin treatment.

We have the infrastructure set up to screen and transplant patients and are happy to evaluate any referred patients. This year, we have already performed islet cell transplants in two patients from previous protocol, allowing them to be insulin free. Even last night, we obtained enough islets, which will be transplanted tomorrow afternoon after proper patient pre-treatment.

If you have any questions or would like to refer patients, please contact the Islet Cell Transplant Coordinator, Lindsay Schenck. She can be reached directly at: LSchenck@surgery.bsd.uchicago.edu or 773-702-2504.

Patients may learn more about this new islet program at www.uchospitals.edu/islets.