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Sponsors and Collaborators: |
City of Hope Medical Center National Institutes of Health (NIH) |
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Information provided by: | City of Hope Medical Center |
ClinicalTrials.gov Identifier: | NCT00706420 |
The purpose of this study is to evaluate the safety and effectiveness of islet cell transplantation alone (ITA) in patients with difficult to control type I diabetes. Difficult to control type 1 diabetes is defined as wide swings in blood glucose that disrupt the patient's life and result in frequent episodes of low blood glucose despite the proper use of standard insulin therapy and frequent blood glucose monitoring.
Condition | Intervention | Phase |
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Diabetes Mellitus |
Procedure: Islet Transplantation + Immunosuppression |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-Free Immunosuppressive Regimen |
Estimated Enrollment: | 20 |
Study Start Date: | January 2002 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Islet cell transplantation alone
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Procedure: Islet Transplantation + Immunosuppression
Islet Transplantation + Immunosuppression (Sirolimus/Tacrolimus, daclizumab)
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Type 1 diabetes is associated with the damage of a specific cell subtype of pancreatic islets (clusters of cells in the pancreas that produce insulin and other metabolic hormones), which makes patients depend on an outside source of insulin. Despite insulin treatment, type 1 diabetes mellitus causes a significant risk of long-term problems, including damage to the heart, blood vessels, nerves, eyes and kidneys. The results of recent research studies suggest that these complications are caused by poor glucose control.
Transplantation of islets offers the prospect of good glycemic (blood glucose) control without the major surgical risks associated with whole pancreas transplant and may result in not needing any insulin injections. In 2000, a group of investigators in Edmonton, Canada showed that islet transplantation using a combination of anti-rejection drugs to help prevent the rejection of transplanted islets was effective in eliminating insulin intake in 7 subjects who were followed up to 20 months. After 5 years, more than 60 patients have been transplanted at Edmonton and only 1 in 10 remained off of insulin.
This study is being performed to confirm the results of the Edmonton study to see if islet transplantation alone (ITA) is a safe and effective way of treating subjects with type 1 diabetes. This study uses a few additional medications and vitamin supplements that were not included in the original Edmonton study. We hope this will improve the long-term outcome of islet transplantation.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Aria Miller | 800-826-4673 ext 62690 | armiller@coh.org |
United States, California | |
City of Hope Medical Center | Recruiting |
Duarte, California, United States, 91010 | |
Principal Investigator: Fouad Kandeel, MD |
Principal Investigator: | Fouad Kandeel, MD | City of Hope Medical Center |
Responsible Party: | City of Medical Center ( Fouad Kandeel, MD ) |
Study ID Numbers: | 01083, RR-01-002 |
Study First Received: | June 25, 2008 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00706420 |
Health Authority: | United States: Food and Drug Administration |
Diabetes Mellitus Islet Transplantation Alone Glucocorticoid-free Immunosuppressive Regimen |
Sirolimus Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Daclizumab Diabetes Mellitus |
Endocrine System Diseases Tacrolimus Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |