Status:
UNKNOWN
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Type 2 Diabetes
Lead Sponsor:
Shandong University
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg for type 2 diabetes.
Detailed Description
1\. Intervention Details: Biological: umbilical cord/placenta-derived mesenchymal stem cells; Drug: 1. Oral Hypoglycemic Drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. 2. Insulins. ...
Eligibility Criteria
Inclusion
- Free will taking part in the study and ability to provide written informed consent
- Type 2 diabetes mellitus (as guideline WHO, 1999)
- Age 18-80 years old, Male/Female
- 19≤Body mass index (BMI)≤30㎏/㎡
- Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％
- Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance
- Not pregnant or nursing
- No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 mmol/L
- No active severe viral or fungus infection
Exclusion
- Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction)
- Active infection requiring treatment
- Unexplained febrile illness
- Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection
- Psychiatric condition that would limit informed consent
- Patient has enrolled another clinical trial study within last 4 weeks.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01413035
Start Date
July 1 2011
End Date
July 1 2014
Last Update
August 9 2011
Active Locations (1)
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1
Department of Hematology of the 2nd Hospital of Shandong University
Jinan, Shandong, China, 250033