Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells
This study has been completed.
Uppsala University Hospital
Information provided by (Responsible Party):
Per-Ola Carlsson, Uppsala University Hospital
First received: February 16, 2010
Last updated: February 4, 2014
Last verified: February 2014
The main hypothesis of the investigators study is that the development of autoimmune diabetes may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Open Study to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells in Treatment of Recently Diagnosed Patients With Type 1 Diabetes Mellitus|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Uppsala University Hospital:
Primary Outcome Measures:
- The concentration of stimulated c-peptide at 90 minutes after the start of a mixed meal tolerance test at 365+/-10 days following the infusion or not with mesenchymal stem cells [ Time Frame: 1 year after intervention ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Mesenchymal stem cells
Comparison of active treatment with autologous mesenchymal stem cells (in addition to standard treatment) to standard treatment of patients newly diagnosed with type 1 diabetes mellitus.
Biological: Mesenchymal stem cells
Autologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.
|No Intervention: Control|
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