Status:
UNKNOWN
Stem Cell Therapy for Type 1 Diabetes Mellitus
Lead Sponsor:
Cellonis Biotechnology Co. Ltd.
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with...
Detailed Description
To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.
Eligibility Criteria
Inclusion
- Free will taking part in the study and ability to provide written informed consent.
- Confirmed diagnosis of type I diabetes for at least 2 years
- Insulin-dependent.
- Age 18-50 years, Male/Female.
- FBG≥7.0 mmol/L, and HbAc1≥7％.
- Not pregnant or nursing.
- Negative pregnancy test.
- Fertile patients will use effective contraception.
Exclusion
- Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
- Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
- Active infection requiring treatment.
- 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
NCT01143168
Start Date
August 1 2010
End Date
December 1 2011
Last Update
June 14 2010
Active Locations (1)
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1
Armed Police General Hospital, P. R. China
Beijing, China, 100085