Status:
UNKNOWN
Stem Cell Therapy for Type 2 Diabetes Mellitus
Lead Sponsor:
Cellonis Biotechnology Co. Ltd.
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.
Detailed Description
* 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. * T...
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 18-75 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;
- Negative pregnancy test;
- Fertile patients will use effective contraception.
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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01142050
Start Date
August 1 2010
End Date
December 1 2011
Last Update
June 11 2010
Active Locations (1)
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1
Armed Police General Hospital, P.R. China
Beijing, China, 100085