Stem Cell Therapy for Type 2 Diabetes Mellitus
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|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 ]
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): NCT01142050
|Armed Police General Hospital, P.R. China|
|Beijing, China, 100085|
|Principal Investigator: Shi X Y, M.D.|