Status:
UNKNOWN
Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients
Lead Sponsor:
Fuzhou General Hospital
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
The study evaluates the safety and efficacy of Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients. The researchers hypothesize that additional Mesenchymal Stem Cell infus...
Eligibility Criteria
Inclusion
- Male and female patients age 18 to 60 years of age
- Ability to provide written informed consent
- Manifest signs and symptoms that are severe enough to be incapacitating
- Patients with poor diabetes control (HbA1c \> 7% but \< 12%)
- Progressive diabetic complications
Exclusion
- age \< 18 years or \> 60 years
- diabetic history \< 5 years
- BMI \> 27
- body weight \> 80 kg
- exogenous insulin requirement \> 1 unit/kg/day
- severe anemia (male \< 8 g/dl, female \< 7 g/dl)
- low white blood cell count (\< 3000/dl)
- liver dysfunction
- Active infection including hepatitis B, hepatitis C, HIV, or TB
- panel reactive antibody \> 20%
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00646724
Start Date
January 1 2008
End Date
January 1 2014
Last Update
June 16 2011
Active Locations (1)
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1
Fuzhou General Hospital
Fuzhou, Fujian, China, 350025