Stem Cell Therapy for Type 2 Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT01142050|
Recruitment Status : Unknown
Verified June 2010 by Cellonis Biotechnology Co. Ltd..
Recruitment status was: Not yet recruiting
First Posted : June 11, 2010
Last Update Posted : June 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Biological: mesenchymal stem cells||Phase 1|
- To evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments.
- To assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Open Labeled and Self Controlled, Safety/Efficacy Assessed Pilot Study on Transplantation Therapy Using Bone Marrow Mesenchymal Stem Cells for Insulin Resistance of Type 2 Diabetes Mellitus|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||August 2011|
|Estimated Study Completion Date :||December 2011|
- Biological: mesenchymal stem cells
1.1st transplantation: after finishing all required examines according to protocol in Day 0, ABM-MSCs are transplanted through pancreas artery percutaneously; 2. 2nd transplantation: after finishing all required examines in Day 7±1, BM-MSCs are transplanted intravenously; 3. 3rd transplantation: after finishing all required examines in Day 14±2, BM-MSCs are transplanted intravenously.
- ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels; [ Time Frame: one year ]
- Insulin resistance index indicated by ITT change compared with baseline.
- Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline.
- Hemoglobin A1c.
- Fast blood glucose (FBG) and Postmeal blood glucose (PBG).
- C-peptide levels.
- Serum Insulin levels.
- Serious adverse event frequency and severity [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142050
|Armed Police General Hospital, P.R. China||Not yet recruiting|
|Beijing, China, 100085|
|Principal Investigator: Shi X Y, M.D.|