Date: 2022-04-12
Type of information: Interim results
phase: preclinical
Announcement: interim results
Company: Cline Scientific (Sweden)
Product: StemCART
Action mechanism: cell therapy. StemCART is an allogenic stem cell therapy based on induced pluripotent stem (iPS) cells that can self-heal cartilage. This preclinical Advanced Therapy Medical Product (ATMP) aims to transform the treatment of cartilage damage.
Disease: cartilage damage
Therapeutic area: Regenerative medicine
Country:
Trial details:
Latest news: • On April 12, 2022, Cline Scientific announced that 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. Beginning in January 2022, Cline has received cartilage tissue from patients undergoing orthopedic prosthetic surgery with the help of its 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 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. 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. Next steps for StemCART include the pursuit of preparation 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.
