Treat and prevent type 1 diabetes by mesenchymal stromal cells

Objective: By an immunomodulating cellular therapy with mesenchymal stromal (stem) cells (MSCs), we aim to prevent death of the insulin-producing beta-cells and maintain beta-cell function in type 1 diabetes in the absence of chronic immune suppression.Study design: Wharton’s jelly-derived MSCs, produced as an advanced therapy medicinal product (ATMP), Protrans®, will be infused intravenously to children and adolescents (7-21-years of age) newly diagnosed for type 1 diabetes.

The study protocol includes a first open safety part, followed by a blinded, placebo-controlled trial in two steps, first in individuals 12.0-21-years of age and then in children 7-11.99-years of age.

If preserved insulin production in treated individuals is obtained at one year follow up, screening of children and adolescents at high risk of developing disease will commence with the ultimate aim of providing a follow up trial for prevention of disease.

Impact: Type 1 diabetes is today a life-long disease that has been shown to restrict the life length of affected children by a median 14-18-years.

A mean to stop beta cell death would provide the possibility to substantially ameliorate glycemic control in affected individuals and even prevent the disease.