GMP NEURAL PROGENITOR CELLS FOR TRANSPLANTATION INTO SPINAL CORD INJURIES

Purpose and goal

** Denna text är maskinöversatt ** The purpose of this project was to produce GMP neural stem cells from GMP iPS cells and to investigate their efficacy in pre-clinical transplants for spinal cord injury. Further objective, to map the path (rules, ethics, IP, the Swedish Medicines Agency) towards the clinic. In principle, we have reached all our objective in the project during the time period, the remaining sub-goals are ongoing and we aim to finish them during 2020. We create new project and work towards the goal of taking iPS derivative ATMP to the clinic.

Expected results and effects

** Denna text är maskinöversatt ** We have produced, quality tested and banked the first GMP iPS cell line in Sweden. We have developed GMP certified matrix to grow and differentiate iPS cells into neural stem cells and examined their efficacy in pre-clinical transplantation for spinal cord injury. We have mapped and documented the process from research to clinic and pharmaceutical product for iPS derivative ATMP products. We (and other researchers in the world) are pleasantly surprised that we succeeded so well with this difficult project.

Planned approach and implementation

** Denna text är maskinöversatt ** We have carried out this project in collaboration between basic research (KI), companies (Biolamina) and clinical research (within SLL). The collaboration has worked very well and has been a prerequisite for the successful goal fulfillment. Despite some delays, we have been able to work ahead in several of the sub-projects and have received answers that will enable us to execute the delayed final pieces faster and more successfully. We plan to seek funding to continue this project.