Islet Transplantation for Type 1 Diabetes Mellitus
The complex program of insulin replacement for type 1 diabetes that is current clinical standard of care is difficult to implement for long periods of time, associated with an increased risk of severe hypoglycemia and implemented by less than 50 % of the population of such patients. Outcomes of transplantation of isolated human islets have substantially improved and been performed at about 40 institutions around the world. We are proposing a clinical phase 1/phase 2 study of islet transplantation alone evaluating safety and efficacy in five patients with type 1 diabetes. Islet isolation from deceased donor pancreases will be performed at the Mayo Rochester Islet Isolation facility and islets infused by Interventional Radiology into the portal venous system. Following islet infusion, patients will be hospitalized for 48 hours in the General Clinical Research Center (GCRC) or at the Rochester Methodist Hospital. Multiple safety and efficacy outcomes will be followed on multiple occasions during the first year and periodically thereafter.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Islet Transplantation for Type 1 Diabetes Mellitus|
- Mean Number of Hypoglycemic Events After Transplant [ Time Frame: 3, 6, 9, and 12 months since islet transplantation ] [ Designated as safety issue: Yes ]Hypoglycemia is an abnormally diminished content of glucose in the blood.
- Mean Glycated Hemoglobin (HbA1c) Since Transplant [ Time Frame: 3, 6, 9, and 12 months since islet transplantation ] [ Designated as safety issue: Yes ]HbA1c is a lab test that shows the average level of blood sugar (glucose) over the previous 3 months. It shows how well the subject is controlling his/her diabetes.
|Study Start Date:||July 2006|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Islet Transplant
Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
Biological: Islet Transplant
Purified pancreatic islets
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437398
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Yogish C. Kudva, M.B.B.S.||Mayo Clinic|