Clinical trial to improve the treatment of diabetes type 1
| Reference number | |
| Coordinator | CORLINE BIOMEDICAL AB - Corline Systems Aktiebolag |
| Funding from Vinnova | SEK 1 000 000 |
| Project duration | November 2014 - June 2018 |
| Status | Completed |
Purpose and goal
The purpose of the project is to run a clinical safety study to improve the outcome of islet transplantation to patients with diabetes type 1; the study is to include up to 10 patients. By pre-treating islets with Cytoparin (Corline´s heparin based cell protection technology) improvement may be made to current outcome, where up to 70 % of islets succumb during the first 60 min after transplantation, leading to an average of 2.7 donors per treated patient. Patient recruitment has not yet started.
Expected results and effects
The project has resulted in: a) that the Cytoparin clinical trial application has been reworked and amended to fit the new regulatory framework for Advanced Therapy Medicinal Product (ATMP) as decided by EU b) that Corline has received a renewed authorization by Swedish MPA to run the clinical with Cytoparin as an ATMP. c) that the manufacturing of Cytoparin modified islets has been validated at the GMP facility at Vecura/Karolinska and approved by MPA. d) the addition of new clinical sites outside of the Nordic region
Planned approach and implementation
Corline has during the project successfully worked with a) Vecura/Karolinska to develop and validate a GMP process for the manufacturing and clinical release of Cytoparin modified islets b) reworking and amending the clinical trial application according to the new regulatory framework for Advanced Therapy Medicinal Products (ATMP) and received a renewed authorization from the MPA to run the clinical study as an ATMP. c) Next step is to further the partnership with the new clinical sites in Edmonton and Oxford in order to speed up recruitment of patients into the study.