A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
|ClinicalTrials.gov Identifier: NCT01897688|
Recruitment Status : Active, not recruiting
First Posted : July 12, 2013
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Severe Hypoglycemic Unawareness||Biological: Islet Cell Transplant||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||March 2027|
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
- 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: Two years after the final islet transplant. ]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 two years after the final islet transplant.
- To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics [ Time Frame: Two years after the final islet transplant. ]To assess the proportion of insulin-independent subjects at two years after the final islet transplant.
- To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics. [ Time Frame: Two years after the final islet transplant. ]To compare islet graft outcome between alemtuzumab induction and historical anti-thymocyte induction groups.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897688
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Xunrong Luo, MD, PhD||Northwestern University|