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Great news! Jiuzhitang Maker's stem-cell therapy for ischemic stroke has entered Phase IIa clinical trials.
2023-06-07
Recently, Jiuzhitang Maker’s ischemic tolerance allogeneic human bone marrow mesenchymal stem cells (it-hMSC) Treating ischemic stroke The Phase I clinical trial (Application No.: JXSL1900126) has completed enrollment of all participants, and Demonstrates good safety performance , following an evaluation by the Center for Drug Evaluation of the National Medical Products Administration, approval has been granted. This project has entered Phase IIa clinical trials. 。
This is an evaluation of a single injection of ischemia-tolerant human allogeneic bone marrow mesenchymal stem cells (it-hMSC) in patients with ischemic stroke. Multicenter, double-blind, randomized, placebo-controlled study on safety, tolerability, and preliminary efficacy The Phase I/IIa study (ASSIST). This trial is conducted in two phases: Phase I is an open-label, dose-escalation study. Phase II is a double-blind, placebo-controlled study. This is the sixth clinical trial application for a new stem-cell-based drug approved by the Center for Drug Evaluation of the National Medical Products Administration, and it also marks China’s first clinical trial using imported stem cells to treat a major neurological indication.
Jiuzhitang Maker's ischemia-tolerant allogeneic human bone marrow mesenchymal stem cells (it-hMSC) are derived from the bone marrow of healthy, young adult donors. Cultured throughout the entire process under low-oxygen conditions that mimic the real physiological environment of the human body— According to the application for registration of imported drugs, this falls under the category of therapeutic biological products. Moving forward, Jiuzhitang Maker will remain steadfast in its mission, Strictly adhere to the drug approval process , continuing to advance the Phase II clinical trial of this project, with the aim of making this drug available to more ischemic stroke patients at the earliest possible date.
Introducing Jiuzhitang Maker
Jiuzhitang Maker was established in March 2018, founded through an investment by the Yonghe Qihang Fund initiated by the century-old pharmaceutical company Jiuzhitang Co., Ltd. (stock code: SZ000989), with registered capital of 200 million yuan. Focusing on the research, development, production, and sales of stem cell drugs and regenerative medicine products. 。
Jiuzhitang Maker has established a large-scale stem cell R&D and production facility—compliant with Chinese, U.S., and EU GMP standards—at the "China Pharma Valley"—Beijing Daxing Biomedical Base. The facility boasts an office and production area of approximately 4,800 m², featuring advanced production platforms. 4 Independent B+A Cleanrooms ， Edible Produced in compliance with China , U.S. pharmaceutical approval requirements for clinical-grade stem cells Currently, we have partnered with several top-tier Grade III hospitals to jointly advance the research and development of multiple stem-cell product pipelines, including those targeting ischemic stroke.
Leveraging advanced manufacturing processes and a robust quality management system, Jiuzhitang Maker has achieved standardized, large-scale production of clinical-grade stem cells. The cell bank, formulations, master cell banks, and high-passage products derived from four different donor sources of human bone marrow mesenchymal stem cells have all successfully passed the comprehensive quality review conducted by the China Institute of Food and Drug Control—and each batch met the required standards. Additionally, Jiuzhitang Maker successfully passed the on-site inspection for certification under the China Association of Medical Biotechnology's "Self-Regulatory Standards for Quality Management in Stem Cell Preparation," and was awarded "Certificate of Quality Management Compliance for Stem Cell Preparation" , becoming a stem cell preparation company certified by the China Association for Medical Biotechnology.
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