Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients

Cotransplantation of Islet and Mesenchymal Stem Cell in Type 1 Diabetic Patients

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 infusion can benefit the promising clinical islet transplantation through the following mechanisms: protection of islet from inflammatory damage, immunological modulation, engraftment promotion, thus decrease or eliminate the need of exogenous insulin and improve β-cell function.

Inclusion Criteria:

• 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 Criteria:

• 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