Mesenchymal stromal cells for the treatment of type 1 diabetes.

Purpose and goal

The project aimed to establish an efficient and automated production of mesenchymal stem cells (MSC), which enables cost effective and large-scale production for patients with newly diagnosed type 1 diabetes. The overall assessment is that the new method meets the pre-established requirements and will be incorporated in future production and commercialization of MSC. Work is now undertaken to establish the new method in the treatment of patients.

Results and expected effects

The traditional manual method of preparing MSC was compared with a novel production method in a closed, automated culture system . Overall, the results show that the new method is time efficient, results in somewhat lower growth potential and provide MSC with preserved characteristics regarding both surface markers and differentiation potential . The project has thus yielded positive results and a new production process has been established that meets the pre-established requirements .

Approach and implementation

Changing the production of a cell-based therapy is a complex and extensive project, requiring more time than originally planned for successful completion of the project. In parallel, long-term agreements have been negotiated with other commercial partners , which create favorable conditions to achieve clinical and commercial success. The project´s design and implementation thus benefit the long-term goal of introducing av new and effective cell-based therapy.