XS-411 / Xellsmart Biomedical - LARVOL DELTA

The Safety and Tolerability of XS411CN Injection in Treatment of Primary Parkinson's Disease (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease • Transplantation

Clinical Study to Evaluate XS411 in Treatment of Early-onset Parkinson's Disease (clinicaltrials.gov) - P1/2 | N=90 | Not yet recruiting | Sponsor: XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.

New P1/2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

The Safety and Tolerability of XS411CN Injection in Treatment of Primary Parkinson's Disease (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease • Transplantation

XellSmart’s Allogeneic iPSC-derived Cell Therapies for Parkinson’s Disease and ALS Officially Approved by the U.S. FDA for Phase I Clinical Trials (PRNewswire) - "...the FDA also granted XellSmart a special exemption to support the clinical trial of XellSmart's cell therapy for PD in the US....The approval of XellSmart's clinical trial, along with the special exemption granted, signifies the FDA's recognition of XellSmart's well-established clinical-grade iPSC-derived cell drug development, production, and quality control systems, as well as its completed preclinical safety and efficacy studies....Additionally, XellSmart's allogeneic, off-the-shelf iPSC-derived dopaminergic neural progenitor cell injection ('XS-411 Injection') has also been approved by China's National Medical Products Administration (NMPA) to enter Phase I clinical trials....XellSmart's off-the-shelf, allogeneic, clinical-grade iPSC-derived cell therapy (XS228) for ALS has been approved by the FDA to enter Phase I clinical trials, making it the first-in-class regenerative neural cell therapy for ALS."

New P1 trial • Amyotrophic Lateral Sclerosis • Parkinson's Disease

Shize Bio’s universal cell therapy receives special exemption from FDA | Member News [Google trnaslation] (bydrug.pharmcube.com) - "In January 2025, the U.S. Food and Drug Administration (FDA) officially approved the Investigational New Drug (IND) application of Shize Biopharmaceuticals (Suzhou) Co., Ltd. for universal iPS-derived dopaminergic neural precursor cell injection for the registration clinical trial of Parkinson's disease (the world's second largest neurodegenerative disease)...In January 2025, the new drug registration clinical trial application (IND) for the universal iPS-derived dopaminergic neural precursor cell injection ('XS-411 injection') developed by Shize Bio for the treatment of Parkinson's disease has been formally accepted by my country's National Medical Products Administration (NMPA)."

IND • New trial • Parkinson's Disease