Islet Transplantation for Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00437398|
Recruitment Status : Terminated (The study was terminated early due to difficulty in recruiting subjects, and ran short of funds.)
First Posted : February 21, 2007
Results First Posted : April 16, 2013
Last Update Posted : April 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Biological: Islet Transplant||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Islet Transplantation for Type 1 Diabetes Mellitus|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
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
- Mean Number of Hypoglycemic Events After Transplant [ Time Frame: 3, 6, 9, and 12 months since islet transplantation ]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 ]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.
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): NCT00437398
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Yogish C. Kudva, M.B.B.S.||Mayo Clinic|