FDA announces that ImStem drug IMS001 that uses AgeX’s pluripotent stem cell technology will be available for treatment of multiple sclerosis.
“Since pluripotent stem cells are capable of differentiating into all human cell types potentially genetically modified in any manner, they open the door to a wide array of new therapies,” said Dr. Michael D. West, PhD, founder and CEO of AgeX. “This collaboration with ImStem is consistent with our aim to make our clinical-grade pluripotent stem cell banks widely available for diverse therapeutic applications.”
IMS001 is a formulation of cells derived from AgeX pluripotent stem cells induced to differentiate into mesenchymal cells (hES-MSC) and through a proprietary method using a trophoblast intermediate stage (hence also known as T-MSC) for the treatment of neurological, autoimmune, and rare orphan diseases.
IMS001 is an investigational, allogeneic cell product to be administered intravenously to patients suffering from MS. ImStem believes this is the first hES-MSC based allogeneic cell therapy accepted for clinical trial by the FDA. ImStem plans to initiate a phase 1 clinical study in patients with relapsing-remitting, secondary, and primary progressive forms of MS in 2020 in the US.
“The clinical-grade pluripotent stem cell lines from AgeX were the first published GMP-compatible lines ever created,” said Xiaofang Wang, MD, PhD, Founder and Chief Technology Officer of ImStem. “As such, they have been widely distributed in the scientific community and demonstrated to meet the needs of industry for relatively rapid product development.”