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 : December 5, 2016
|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 :||20 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 :||December 2017|
|Estimated Study Completion Date :||December 2018|
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: 365 days after final islet infusion ]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 ]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.
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) email@example.com|
|Contact: Ojoma Agbo, MSc||(312) firstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Xunrong Luo, MD, PhD 312-908-8147 email@example.com|
|Contact: Ojoma Agbo, MSc (312) 694-0253 firstname.lastname@example.org|
|Principal Investigator: Xunrong Luo, MD, PhD|
|Principal Investigator:||Xunrong Luo, MD, PhD||Northwestern University|