Hopstem Biotechnology Co., Ltd, a neural stem cell specialist founded by neuroscientists and stem-cell biologists from Johns Hopkins University, has announced receiving tacit clinical trial approval from China’s Center for Drug Evaluation (CDE) for its hNPC01. This induced pluripotent stem cells (iPSC) derived cell therapy is intended for the treatment of sequela of hemiplegia after ischemic stroke.
hNPC01: A Clinical Grade Human Forebrain Nerve Precursor Cell
HNPC01 is developed based on the second generation patented neural differentiation technology (RONA2.0) unique to Hopstem Bio and differentiated from the iPSC cell line working library. The therapy has demonstrated the ability to survive long-term after being transplanted into the brain parenchyma of rodent and non-human primate brain infarction models. It can differentiate into a variety of cortical functional neurons and glial cells, closely resembling the composition and functional maturity of the human cerebral cortex.
Safety and Efficacy of hNPC01
No product-related toxic reactions or tumorigenicity were found in a multitude of in vitro and in vivo studies for hNPC01, including comprehensive one-year studies on tumorigenesis and tumorigenicity. A double-blind pharmacological trial based on a non-human primate model of severe cerebral infarction showed that animals receiving hNPC01 cell transplantation after 15 days of cerebral infarction achieved significantly faster and better functional recovery than control animals.
Phase I Study Design and Objectives
The Phase I study will enroll patients with acute ischemic stroke onset for 6-60 months and accompanied by unilateral limb motor dysfunction. The study aims to assess the safety and tolerability of hNPC01 in improving the sequelae of hemiplegia after ischemic stroke. The drug is also being explored for its potential in treating forebrain-related degenerative diseases and more.-Fineline Info & Tech
