Stem Cell Therapy for Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01143168|
Recruitment Status : Unknown
Verified June 2010 by Cellonis Biotechnology Co. Ltd..
Recruitment status was: Not yet recruiting
First Posted : June 14, 2010
Last Update Posted : June 14, 2010
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Biological: autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||December 2011|
- Biological: autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells
First Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 7±1, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines on Day 14±2, BM-MNCs + UCMSCs are transplanted intravenously.
- Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels. [ Time Frame: 1 year ]Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.
- Serious adverse event frequency and severity [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143168
|Armed Police General Hospital, P. R. China||Not yet recruiting|
|Beijing, China, 100085|
|Principal Investigator:||Shi X Y, M.D.||Armed Police General Hospital, P. R. China|