Interactive guide for clinical trials in cell therapy
| Reference number | |
| Coordinator | Karolinska Universitetssjukhuset - Karolinska Trial Alliance - Huddinge närakut |
| Funding from Vinnova | SEK 295 500 |
| Project duration | August 2014 - November 2016 |
| Status | Completed |
Purpose and goal
1.Implement, use, evaluate and adapt a guide for cell therapy studies It is used in planning and applications of Clinical studies in cell therapy at KTA. 2.Facilitate implementation of clinical studies in cell therapy, within the region. The guide is available on www.kliniskastudier.se 3. The guide should be used in other therapeutic areas and in other institutions / hospitals. The work is currently planned. 4. Development of a process model for (ATMP) - a team is appointed to ensure quality and organizing of Advanced therapy Medical Product (ATMP) within Karolinska.
Expected results and effects
1.By facilitate clinical studies in cell therapy will Karolinska be an attractive partner. 2. Increase the number of clinical cell therapy studies in Sweden. 3. increase Sweden´s attractiveness as a hub for the development of cell therapies. The guide helps to better the quality of the applications. 4. Attract the best researchers, biotech and pharmaceutical companies to Sweden. 5. To make available validated cell therapy treatment to the patient.
Planned approach and implementation
1. Handover of the guide from Innovationsplatsen to KTA has been performed. 2. Implementation of the guide and continuous adjustment to the associated work processes and operations at KTA has been performed. 3. The benefit for Clinical celltherapy research is demonstrated by an increasing number of researchers that are turning to KTA for assistance. 4. The guide is presented at GCP-course, seminar and mail 5. The ability to access the guide is given 6. Work is underway that the guide should be made a national available