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Sponsors and Collaborators: |
University of Florida Juvenile Diabetes Research Foundation National Institutes of Health (NIH) |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00305344 |
While this study is now completely enrolled, we do hope to develop a "next generation" cord blood based study sometime in early 2009. Please continue to contact us if you have a child with newly diagnosed Type 1 Diabetes who alo has their OWN cord blood in storage.
Condition | Intervention | Phase |
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Type 1 Diabetes Mellitus |
Procedure: Autologous Umbilical Cord Blood Transfusion |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Transfusion of Autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children With Type 1 Diabetes - A Pilot Study |
Estimated Enrollment: | 23 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 1 Year and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32610 |
Principal Investigator: | Michael J Haller, MD | University of Florida |
Principal Investigator: | Desmond A Schatz, MD | University of Florida |
Responsible Party: | University of Florida ( Michael Haller, MD ) |
Study ID Numbers: | 1-2005-362, GCRC 593, UF IRB-01 125-2004 |
Study First Received: | March 17, 2006 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00305344 History of Changes |
Health Authority: | United States: Food and Drug Administration; University of Florida: IRB-01; University of Florida: Pediatric Data Safety Monitoring Board |
Type 1 Diabetes Mellitus Umbilical Cord Regeneration Insulin Islets of Langerhans |
Autoimmune Diseases Metabolic Diseases Hyperglycemia Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |