A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Type 1 Diabetes
Severe Hypoglycemic Unawareness
Biological: Islet Cell Transplant
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients|
- To demonstrate the safety and efficacy of islet transplantation under alemtuzumab induction for treatment of Type-1 Diabetes (T1D) in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes. [ Time Frame: 365 days after final islet infusion ] [ Designated as safety issue: Yes ]To assess the efficacy of islet cell transplantation under alemtuzumab induction immunosuppression on the proportion of subjects with a change in HbA1c and free of severe hypoglycemic events through Day 365 after the final islet transplant.
- To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics. [ Time Frame: 365 days after final islet infusion ] [ Designated as safety issue: No ]To assess the proportion of insulin-independent subjects at Day 365 after the final islet transplant. TO compare islet graft outcome between alemtuzumab induction and historical antithymocyte induction groups. To relate clinical transplant outcomes based upon islet quantity/quantity to organ donor characteristics.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Islet Cell Transplant
All qualified subjects will be put on United Network for Organ Sharing (UNOS) Islet Transplant wait list for potential islet cell transplant.
|Biological: Islet Cell Transplant|
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|Contact: Xunrong Luo, MD, PhD||(312) firstname.lastname@example.org|
|Contact: Natalie Monson, BA||(312) email@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Xunrong Luo, MD, PhD 312-908-8147 firstname.lastname@example.org|
|Contact: Natalie Monson, BA (312) 694-0253 email@example.com|
|Principal Investigator: Xunrong Luo, MD, PhD|
|Principal Investigator:||Xunrong Luo, MD, PhD||Northwestern University|