A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT01897688|
Recruitment Status : Recruiting
First Posted : July 12, 2013
Last Update Posted : June 25, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897688
|Contact: Xunrong Luo, MD, PhD||(312) firstname.lastname@example.org|
|Contact: Ojoma Agbo, MSc||(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: Ojoma Agbo, MSc (312) 694-0253 email@example.com|
|Principal Investigator: Xunrong Luo, MD, PhD|
|Principal Investigator:||Xunrong Luo, MD, PhD||Northwestern University|