XS228 / Xellsmart Biomedical - LARVOL DELTA

Current status of neural progenitor/stem cells for spinal cord injury: fundamental research and clinical trials. (PubMed, Front Neurol) - "Subsequently, we systematically analyze 19 clinical trials of NPC/NSC-based products conducted in 10 countries, covering HuCNS-SC, LCTOPC1, NSI-566, hESC-OPC, and the emerging iPSC-derived product XS228. No NPC product has yet achieved regulatory approval, reflecting persistent challenges in cell source optimization, safety control, graft survival, in vivo tracking, and trial design. Nevertheless, by integrating rigorous cell source selection, rational gene modification, advanced delivery systems, and well-designed clinical trials targeting carefully defined patient populations, NPCs are expected to achieve meaningful-and potentially transformative-clinical benefits for individuals with SCI in the future."

Journal • Review • CNS Disorders • Oncology • Orthopedics • Transplantation

The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Amyotrophic Lateral Sclerosis • CNS Disorders

Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Third Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Orthopedics • Transplantation

The Safety, Tolerability and Preliminary Efficacy of Derived Motor Neuron Progenitor Cells (XS228CN) in Subjects With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.

New P1 trial • Amyotrophic Lateral Sclerosis • CNS Disorders

XellSmart Completed World's First Patient Dosing in its Registrational Clinical trial for iPSC-derived Subtype-specific Neural Cell Therapy for Spinal Cord Injury (PRNewswire) - "XellSmart Biopharmaceutical...achieved a significant milestone in its 'world's first' China NMPA & US FDA-approved registrational clinical trial. This Phase I China registrational clinical trial for XS228 Cell Injection – the world's first 'off-the-shelf', allogeneic, iPSC-derived, spinal neural progenitor cell therapy targeting major neurological disorders, specifically spinal cord injury (SCI) – has commenced. The clinical trial initiation meeting was held at The Third Affiliated Hospital of Sun Yat-sen University (SYSU-3) in Guangzhou. Following this, the world's first patient dosing with the therapy was successfully administered."

Trial status • CNS Disorders

Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase II Randomized Controlled Trial (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

New P2 trial • CNS Disorders • Orthopedics • Transplantation

Safety and Early Efficacy of iPSC-Derived Motor Neuron Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

New P1 trial • CNS Disorders • Orthopedics • 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