XS-411 / Xellsmart Biomedical - LARVOL DELTA

Advances in Parkinson's Disease Cell Therapy: XellSmart Launches a Multicenter Phase II Clinical Trial Following Encouraging Phase I Results (AllSci Corp) - "The trial continues to be led by Beijing Tiantan Hospital affiliated to Capital Medical University — a National Center for Neurological Disorders, and is again jointly conducted with Peking Union Medical College Hospital, the Second Affiliated Hospital of Soochow University, and more top-tier hospitals....Positive Phase I Results...In terms of efficacy, multiple follow-up assessments following iPSC-derived cell implantation demonstrated significant improvements in key motor outcomes among enrolled patients relative to pre-transplant baseline...In terms of objective imaging evidence, 18F-DOPA PET-CT molecular imaging performed after treatment revealed a significant increase in 18F-DOPA uptake in the putamen compared with pre-transplant baseline, demonstrating markedly enhanced signal intensity from newly generated dopaminergic neurons in the putamen."

P1 data • Trial status • Parkinson's Disease

China-based XellSmart Biopharmaceutical Co., Ltd. announced that the US FDA has granted Fast Track Designation (FTD) to XS411, an allogeneic, off-the-shelf, induced pluripotent stem cell (iPSC)-derived dopaminergic neural progenitor cell therapy, for the treatment of Parkinson's disease. (AllSci Corp) - "The designation positions XS411 for rolling Biologics License Application (BLA) submission and eligibility for Priority Review upon meeting specified clinical endpoints, accelerating a US regulatory pathway for a cell therapy class that has no approved representative in any major market...The FTD follows Phase I data from a registrational trial at Beijing Tiantan Hospital....Those Phase I results supported the launch of a multicenter Phase II registrational trial in China, which completed enrollment in July 2026."

Enrollment closed • Fast track • Parkinson's Disease

The Safety, Tolerability, and Efficacy of Dopaminergic Neural Progenitor Cells (XS411CN Cell Injection) for the Treatment of Multiple System Atrophy Parkinsonian Variant (MSA-P). (clinicaltrials.gov) - P1 | N=3 | Not yet recruiting | Sponsor: XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.

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

XellSmart Receives Fourth Consecutive US FDA & China NMPA IND Clearance for MSA-P iPSC-derived Cell Therapy (The Manila Times) - "China and the US Phase I/II registrational clinical trials targeting MSA-P, projected to be kicked off in 2026; China and the US Phase I registrational clinical trials targeting Spinal Cord Injury, employing XellSmart's potentially First-in-Class product, led by the Third Affiliated Hospital of Sun Yat-sen University."

IND • New P1/2 trial • Multiple System Atrophy • Parkinson's Disease

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

Enrollment open • 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 | 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