Type 1 Diabetes Mellitus
Conditions
Brief summary
This project aims to evaluate the efficacy of autologous mesenchymal stem cell treatment to preserve insulin production and beta-cell mass in recently diagnosed patients with type 1 diabetes mellitus. The hypothesis to be tested is that an increased number of circulating mesenchymal stem cells will provide immune modulatory properties, and thereby stop the immune process in islets causing progressive beta-cell death.
Interventions
PROCEDUREsham transplantation of mesenchymal stem cells
Placebo control for transplantation of mesenchymal stem cells
Sponsors
Uppsala University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* fasting C-peptide \>0.12 nmol/l * within three weeks of diagnosis of type 1 diabetes
Exclusion criteria
* body mass index (BMI) \>30 * unstable cardiovascular status incl. New York Heart Association (NYHA) class III/IV * patients with known or previous malignancy * active infections incl. serological evidence of infection with HIV, Treponema pallidum, hepatitis B (patients with serology consistent with previous vaccination and a history of vaccination are acceptable) or hepatitis C. * immune suppressive treatment * women being pregnant or nursing, or women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ∆-change of C-peptide Area Under the Curve (AUC) (0-120 min) for a mixed meal tolerance test at two year follow-up when compared to pre-treatment values at enrolment. | ∆-change will be assessed as a difference between two years after transplantation/sham transplantation of mesenchymal stem cells when compared to before transplantation/sham transplantation, i.e. at time 0. |
Countries
Sweden
Outcome results
None listed