Cline successfully completes first stage of StemCART ex-vivo testing on human cartilage
Cline Scientific AB (“Cline” or “The Company”) has now completed the first stage related to the ex-vivo testing of its cartilage repair product, StemCART, on human cartilage tissue. Cline has carried out 12 implantation experiments with patient specimens according to the plan and protocol. Initial results show encouraging performance.
The supporting matrix, which has been developed for use together with the cartilage cells, demonstrated the expected functionality in successfully fixing cells to the area of interest, which is one key aim of the ex-vivo testing.
The ex-vivo tests continue and will be expanded with tissue of different cartilage origin. The plan is to carry out 24 more experiments in several stages. Results from these will be communicated after the completion of each stage.
These proof of concept tests are an important step in validating the StemCART product concept and moving StemCART to the next development stage.
Next steps for StemCART
StemCART is a preclinical Advanced Therapy Medical Product (ATMP) that aims to revolutionize the treatment of cartilage damage for patients worldwide. To achieve this, Cline will continue preparing for in-human clinical trials, including scaling up production into a GMP facility, developing QA/QC methods, and the necessary safety testing and documentation for a clinical trial application. Cline envisions out-licensing StemCART to a commercial partner following successful phase I trials.
About the ex-vivo testing
Beginning in January 2022, Cline has received cartilage tissue from patients undergoing orthopedic prosthetic surgery with the help of our clinical collaborators. The team then induces artificial cartilage damage to mimic joint injuries and then implants the cells and matrix together at the injury site of the tissue sample. The aim is to show that Cline’s unique method successfully differentiates iPSCs into functional chondrocyte cells, that the matrix successfully supports the cells in place, and that healing of injured cartilage tissue is induced.
- Hanne Evenbratt, VP