XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd., in collaboration with Shanghai East Hospital (Tongji University Affiliated East Hospital) and Liu Zhongmin’s team, has successfully enrolled the first patient in the global clinical study for “Clinical Grade iPSC-Derived Subtype Neural Progenitor Cell Therapy for Amyotrophic Lateral Sclerosis (ALS).” This marks a significant milestone in the treatment of ALS, also known as Lou Gehrig’s disease or motor neuron disease.
Approval and Significance of the Clinical Study
The clinical research has been formally approved by the national regulatory authorities as a national stem cell filing clinical research project. This study represents China’s first and only officially approved clinical research using iPSC-derived cell therapy for ALS and is the world’s first clinical study of allogeneic, universal clinical-grade iPSC-derived neural cells for the treatment of ALS. The study is conducted in accordance with guidelines such as the “Technical Guidelines for Pharmaceutical Research and Evaluation of Human Stem Cell Products” and the “Technical Guidelines for Clinical Trials of Human Stem Cell-Derived Cell Therapy Products,” issued by the CDE, as well as the “Administrative Measures for Clinical Stem Cell Research (Trial)” and the “Guiding Principles for Quality Control and Preclinical Research of Stem Cell Preparations (Trial)” .
Innovation and Development of XellSmart Bio
XellSmart Bio, founded by Dr. Li Xiang, is dedicated to developing clinical-grade iPSC-derived cell therapies for neurological diseases like Parkinson’s and ALS, which lack effective clinical solutions. The company has assembled a full-time team with international competitiveness and industry experience, establishing a suite of proprietary, leading-edge technologies and platforms for sustainable innovation. XellSmart Bio has independently built and operates a comprehensive platform of over 5,000 square meters, including R&D centers, B+A grade GMP bases, and quality control centers. The company’s multiple clinical-grade iPSC-derived cell therapies have completed core CMC development, established full-process clinical-grade manufacturing processes, and quality control systems, and have achieved formal registration batch and clinical batch production for various GMP-grade iPSC-derived subtype specialized neural progenitor cell therapy products.-Fineline Info & Tech
