Journal of Clinical Toxicology
Open Access
ISSN: 2161-0495
ISSN: 2161-0495
Envigo CRS Israel Limited, Ness-Ziona 7414001, Israel
Research Article
Toxicity Studies on Intrathecal Injection of Low Dose of DMSO Used for Cryopreservation of Human Astrocytes in Mice
Author(s): Tehila Sonnenfeld*, Einat Rauchbach*, Rotem Downey*, Daniel Blumenkrants, Arik Hasson, Graciela Kuperstein, Noam Kronfeld, Raanan Margalit, Kfir Molakandov, Vered Morad, Abraham Nyska, Shalom Guy Slutsky, Michel Revel and Michal Izrael*
Background: AstroRx® is an allogeneic cell therapy, composed of healthy and functional human astrocytes derived from pluripotent embryonic stem cells. An intrathecal injection of a fresh formulation of AstroRx® cells for the treatment of Amyotrophic Lateral Sclerosis (ALS) was evaluated in an early-phase I/IIa clinical trial. The results of this study indicated that the treatment is safe and showed a signal of a clinical benefit in attenuating ALS progression. Due to the logistical challenges associated with the manufacturing and distribution of a fresh cell product and to allow completion of safety and quality control testing before cell administration, a cryopreserved formulation of AstroRx® was developed. The cryopreseved AstroRx® product includes 3.5% DMSO as a cryoprotectant. Upon thawing at the clinical.. View More»
DOI:
10.35248/2161-0495.24.13.553