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

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Type 1 Diabetes Mellitus

Treatments

Biological: cotransplantation of islet and mesenchymal stem cell

Study type

Interventional

Funder types

Other

Identifiers

NCT00646724

fuzhough0712

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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