XellSmart's Breakthrough Therapies for Parkinson's and ALS Approved by FDA for Clinical Trials
A New Era in Neurodegenerative Disease Treatment
XellSmart Biopharmaceutical (Suzhou) Co., Ltd. has made a significant breakthrough in the realm of neurodegenerative diseases by receiving FDA approval for its cell therapies targeting both Parkinson's Disease (PD) and Amyotrophic Lateral Sclerosis (ALS). This approval marks the beginning of Phase I clinical trials for their innovative treatment approach that utilizes iPSC-derived dopaminergic neural progenitor cells.
FDA Approval Details
In January 2025, the U.S. Food and Drug Administration (FDA) officially greenlit XellSmart's Investigational New Drug (IND) application, allowing the company to initiate clinical trials in the United States. The therapy, known as
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