The Site Initiation Visit (SIV) of the Phase 1 clinical trial on the indication of hemiplegia sequelae after chronic ischemic stroke with the hNPC01 universal cell therapy product of Hopstem Biotech was successfully held.

2023/05/25

On May 23rd, 2023, the launch meeting of the clinical research project of Hopstem's hNPC01 product for the treatment of stroke sequelae was successfully held. At the meeting, members of Hopstem's clinical medical team had in-depth communication with the cooperating clinical research PI expert team on the clinical research plan, process, project management, statistical analysis, drug vigilance and clinical monitoring, and inspection plan of the product. The team of doctors involved in this research project has accumulated a wealth of experience in precise transplantation of neural stem cells in the brain since 2013, making important contributions to the development of this field. The aim of this cooperation is to jointly accelerate the exploratory research of iPSC-derived cell therapy for the international innovation of stroke sequelae treatment, and provide useful support for the registration of clinical phase I of the product. The first phase of this clinical research is a single-arm, open-label dose escalation trial, which will mainly explore the safe dose of hNPC01 in patients with stable hemiplegia after cerebral infarction through precise intracranial injection, and explore the feasibility of clinical treatment conditions and functional cell replacement to promote the reconstruction of neural circuit function.


Currently, there is only one similar product to Hopstem's hNPC01 internationally, which is the iPSC-derived forebrain neural progenitor cells led by Dr. Gary Steinberg of Stanford University. The clinical study, supported by NIH and other funding sources, for the treatment of stroke sequelae began clinical enrollment in April 2022. Hopstem's hNPC01 product is the first domestically produced multipotent stem cell-derived forebrain neural progenitor cell product to receive approval for clinical application by China's CDE and is preparing to enter clinical trials. It is also the first cell product of its kind to undergo FDA IND application. Hopstem upholds the concepts of "patient first" and "accumulating strength to make a splurge". Based on a large amount of preclinical and pharmaceutical work, the company strives to explore and validate the safety and efficacy of its products through leading and high-quality cell engineering technology products, as well as high-quality, compliant clinical research and clinical trials. Hopstem aims to provide affordable, consistent, safe, and effective treatment products for patients as soon as possible.

Share

Company News

XML 地图