Athersys, MedCision Partner on High-Volume ThawSTAR Cell Thawing Systems for Use in Clinical Trials
MedCision and Athersys have formed a strategic partnership to include the use of the ThawSTAR® Cell Thawing System in Athersys’ clinical trials.
In the first stage of the partnership, Athersys adopted MedCision’s ThawSTAR AT6 Transport and Thawing System for 6 mL AT-Closed Vial® (Aseptic Technologies S.A.) to de-risk the cell thawing process and optimize cell efficacy in their Phase 2 trial using MultiStem® cell therapy to treat subjects with Non-ST Elevation Acute Myocardial Infarction (NSTEMI).
“The use of the ThawSTAR Cell Thawing System allows us to remove variability and subjectivity associated with traditional methods,” stated Gil Van Bokkelen, Chairman and CEO of Athersys. “Together, our companies plan to implement a novel cell thawing solution for use in future trials, including automated thawing of larger-volume vials for indications where IV delivery is appropriate.”
Large-volume cell thawing is particularly challenging because considerations must be given to osmotic imbalances, thermal gradients and varying intra-vessel phase states. An industry first, MedCision’s proprietary cell thawing technology is able to overcome these biophysical challenges and ultimately ensure that optimal, post-thaw cell health and efficacy is achieved.
“Thawing is a vital and frequently overlooked step in the cold chain,” said Rolf O. Ehrhardt, MD, Ph.D., MedCision CEO. “The ThawSTAR high-volume system is an automated and reproducible thawing platform that will allow Athersys to improve the overall handling of its cell therapies and further ensure the high quality and integrity of its investigational cell-based product.”
The proprietary ThawSTAR thawing system for 6 mL AT-Closed Vials has been recently launched and utilizes a novel adaptive algorithm specific to each unique cell therapy product. The algorithm operates on an understanding that cell size, volume and choice of cryopreservative affect the thawing rate needed to preserve optimal function in a given cell type. Additionally, the algorithm customizes the thaw for each fill volume, ensuring consistent and reproducible endpoints. Vials can be inserted directly from liquid nitrogen storage (below -150°C) or dry ice/ultra-low freezer storage (-80°C).