Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study

Mesenchymal Stem Cells to Intervene in the Development of Type 1 Diabetes: a Blinded Randomized Study

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.

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