|Coordinator||Karolinska Institutet - Institutionen för laboratoriemedicin|
|Funding from Vinnova||SEK 25 000 000|
|Project duration||January 2011 - December 2016|
Purpose and goal
The overall purpose of the initiative Cell Therapies is to promote the development of cell therapy products for the treatment of patients with severe or life-threatening diseases. The VINNOVA-funded environment has created a coherent environment that includes innovative research, quality assurance, GMP-driven process development and groundbreaking clinical development. During the project, regulatory and patent-based expertise has been linked to the environment. The consortium has quality assured and developed a number of cell therapy products.
Expected results and effects
During the projet period, the process of producing mesenchymal stroma cells (MSC) has been quality assured and transferred to GMP standards, which is a prerequisite for establishing MSC as clinical treatment for the prioritized indications. A Phase I / II clinical trial in patients with multiple myeloma where CellProtect (autologous NK cell product) was studied as additional therapy to the standard of care has been performed. The results of the project provide a stable foundation to continue the successful development of innovative treatment strategies for severely ill patients.
Planned approach and implementation
During the project period, a number of protocols and methods for the production of patient-safe and clinically effective cellpreparations have been developed. Validated manufacturing methods are established at Karolinska Center Cell Therapy (KCC) Vecura. The refinement of cell therapy with MSC and NK cell preparations is dependant on clinical trials ibeing perfomed in parallel with a careful evaluation of the treatment and a methodological product development. The consortium has actively participated in and strengthened both domestic and international networks in the field.