Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)
Recruitment status was Active, not recruiting
Type 1 diabetes (T1D) is still associated with tremendous morbidity and premature mortality.
Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. Unfortunately, there is presently no permanent cure for diabetes. Whole pancreas or islet cell transplantation is available only to a very limited number of patients and necessitates potential lifelong immunosuppressive therapy. Autologous stem cell transplants have been used successfully for ALL (acute lymphoblastic leukemia), AML (acute myeloblastic leukemia) and for the treatment of a variety of cancers including breast cancer and neuroblastomas, and more recently for the treatment of autoimmune disorders such as multiple sclerosis (MS), lupus-like disease, and rheumatic disorders. Recently it was shown that bone marrow-derived stems cells transplanted into diabetic mice led to reduced hyperglycemia within 7 days after transplantation and was sustained until they were sacrificed at 35 days post-transplantation. The investigators' goal is to transfuse autologous umbilical cord blood into 23 children (Germany 10 and 20 Controls) with T1D in an attempt to regenerate pancreatic islet insulin producing beta cells and improve blood glucose control. As secondary goals, the investigators aim to track the migration of transfused cord blood stem and study the potential changes in metabolism/immune function leading to islet regeneration.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Transfusion of Autologous Umbilical Cord Blood to Reverse Hyperglycemia in Children With Type 1 Diabetes - A Pilot Study.|
- insulin production [ Designated as safety issue: No ]change in median area under the curve (AUC) for C-peptide (measure of insulin production) from baseline to 2 years during a 2h Mixed Meal Tolerance Test was used as the primary outcome measure and was reported in ng/mL/120 minutes.
- Insulin Dose, Autoantibody levels, T-cell functional response assays, Cytokine levels [ Designated as safety issue: No ]Insulin Dose, Autoantibody levels, T-cell functional response assays, Cytokine levels
- glycated hemoglobin (HbA1c) [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: A||
Other: Umbilical Cord Blood VITA 34
Intervention type: Autologous Umbilical Cord Blood Transfusion
|No Intervention: B|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989547
|Forschergruppe Diabetes der Technischen Universität|
|München, Bavaria, Germany, 80804|