Islet Transplantation in Patients With "Brittle" Type I Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01630850|
Recruitment Status : Recruiting
First Posted : June 28, 2012
Last Update Posted : June 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Biological: Allogenic islet cells (human, U. Chicago) Procedure: Intraportal infusion of islet cells||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Islet Transplantation in Patients With "Brittle" Type I Diabetes|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||June 2021|
|Experimental: Allogenic islet cells (human, U. Chicago)||
Biological: Allogenic islet cells (human, U. Chicago)
Human allogenic islet cells. Immunosuppression may include remicade, thymoglobulin,prograf, solu-medrol, and cellcept. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.
Procedure: Intraportal infusion of islet cells
Intraportal infusion of islet cell through the portal vein in the liver.
- HbAlc <7.0% and an absence of severe hypoglycemic events [ Time Frame: 1 year ]The proportion of subjects with an HbAlc <7.0% at Day 365 AND free of severe hypoglycemic events from Day 28 to Day 365 inclusive following the first islet transplant.
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): NCT01630850
|Contact: Lindsay Schenck, RN, BSN||773-702-2504||Lschenck@surgery.bsd.uchicago.edu|
|Contact: Piotr Witkowski, MD, PhD||(773) email@example.com|
|United States, Illinois|
|University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Lindsay Schenck, RN, BSN 773-702-2504 Lschenck@surgery.bsd.uchicago.edu|
|Principal Investigator: Piotr Witkowski, MD, PhD|
|Principal Investigator:||Piotr Witkowski, MD, PhD||University of Chicago|