D3.394 - Assessment of safety and tolerability of mesenchymal stem cells and tolerogenic dendritic cells as a therapy for type 1 diabetes

Mesenchymal stem cells (MSC) and tolerogenic dendritic cells (tolDC) primed with autoantigen may help in the treatment of type 1 diabetes (T1D). Safety and tolerability of MSC and tolDCs as a therapeutic agent for type T1D was assessed in a clinical trial.

Immunotherapy was provided to 9 patients (6 male and 3 female; 26.4±6.7 years) with  established diagnosis of T1D who had positive antibodies to GAD65 and residual secretion of B-cells. The duration T1D was 4-10 months from the moment of manifestation. Intravenously injections of MSC and subcutaneous injections of tolDCs (primed with GAD65 peptides) were performed 1-3 times at a  one month interval. MSC counts ranged from 1 million per  kg of weight, tolDC counts ranged from 1.0 to 3.3 million with viability from 85.8 to 98.9%.

Hyperemia or skin rash at the injection site were not observed. There were no Type I hypersensitivity reactions. Body temperature and  blood pressure assessed a day later did not reveal deviations from normal.

Immunotherapy with MSC and tolDCs as a treatment for T1D in this limited population is safe and well tolerated short term. Allergic reactions and other undesirable side effects were not identified.