Since January 2022, Cline has been conducting testing of StemCART on human cartilage tissue that has been removed during prosthetic surgery. The idea has been to test the StemCART product on cartilage tissue that has been artificially injured to mimic cartilage damage and test the cells as well as their ability to repair the tissue. Building on earlier updates, Cline has now conducted the first full series of experiments.
The project had three primary sub-goals: to show that the method develops stem cells into functional cartilage cells, to test the cells' regenerative ability in injured cartilage tissue, and to evaluate the matrix's ability to support the cells in place.
For the first aim, analyses show that the cells express chondrocyte markers while pluripotency markers decrease. This verifies that the cells have differentiated as expected toward native chondrocytes. On the same aim, cell viability was shown to be high during activation on Cline's unique surface, confirming our methods safe and effective impact on the cell development. These results are important as they contribute to the safety and quality of the cells produced.
The second aim was to study the cells' regenerative ability of the induced cartilage injuries. It was observed that the implanted cells interact with the cartilage tissue which is what the team hoped to see. The result is encouraging as it is a central part of how StemCART will heal injured cartilage in patients.
The final aim was to test the performance of the matrix which supports the cells in place during implantation. As communicated earlier on the 11th of April, results demonstrated the matrix exhibited the expected functionality.
"Through this project, we have gained valuable knowledge and have confirmed the value of moving forward in the StemCART development plan. The lessons we have learned give us the opportunity to further optimize the product with small adjustments to facilitate the future necessary clinical studies." Dr Hanne Evenbratt, PhD, VP R&D.
The path ahead 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.
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