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Sponsors and Collaborators: |
University of Miami National Institutes of Health (NIH) |
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Information provided by: | University of Miami |
ClinicalTrials.gov Identifier: | NCT00315614 |
SPECIFIC AIMS:
Condition | Intervention | Phase |
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Type 1 Diabetes Mellitus |
Procedure: Islet Transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Islet Cell Transplantation Alone and CD34+ Enriched Donor Bone Marrow Cell Infusion in Patients With Type 1 Diabetes Mellitus; Steroid Free Regimen |
Estimated Enrollment: | 6 |
Study Start Date: | December 2000 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
In our current protocol (IRB #2000/0024) the immunosuppressive regimen, comprised of induction with daclizumab and maintenance therapy with sirolimus and tacrolimus, has been combined with the infusion of CD34+ enriched donor bone marrow stem cells in an attempt to create a chimeric state and hence induce donor tolerance. This strategy was tested by evaluating graft survival following the removal of all immunosuppressive medication after one year.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One or more of the following:
Exclusion Criteria:
Contact: Rodolfo Alejandro, MD | 305-243-5324 | |
Contact: Camillo Ricordi, MD | 305-243-6913 |
United States, Florida | |
Diabetes Research Institute | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Rodolfo Alejandro, MD 305-243-5324 ralejand@med.miami.edu or islet@med.miami.edu | |
Contact: Camillo Ricordi, MD 305-243-6913 islet@med.miami.edu | |
Sub-Investigator: Camillo Ricordi, MD |
Principal Investigator: | Rodolfo Alejandro, MD | Diabetes Research Institute University of Miami |
Responsible Party: | Diabetes Research Insititute, University of Miami ( Rodolfo Alejandro, MD ) |
Study ID Numbers: | 2000/0024 |
Study First Received: | April 14, 2006 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00315614 |
Health Authority: | United States: Food and Drug Administration |
Islet Transplantation |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |