Cline Scientific completed the first stage related to 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.
Cline will continue preparing for in-human clinical trials by 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.
Source: Cline Scientific