{"id":28949,"date":"2025-07-28T20:03:02","date_gmt":"2025-07-28T20:03:02","guid":{"rendered":"https:\/\/www.hotelsalepage.com\/feed\/cision-pr-newswire\/xellsmart-completed-worlds-first-patient-dosing-in-its-registrational-clinical-trial-for-ipsc-derived-subtype-specific-neural-cell-therapy-for-spinal-cord-injury\/"},"modified":"2025-07-28T20:03:02","modified_gmt":"2025-07-28T20:03:02","slug":"xellsmart-completed-worlds-first-patient-dosing-in-its-registrational-clinical-trial-for-ipsc-derived-subtype-specific-neural-cell-therapy-for-spinal-cord-injury","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=28949","title":{"rendered":"XellSmart Completed World’s First Patient Dosing in its Registrational Clinical trial for iPSC-derived Subtype-specific Neural Cell Therapy for Spinal Cord Injury"},"content":{"rendered":"

SUZHOU,\u00a0China<\/span>, July 28, 2025<\/span><\/span> \/PRNewswire\/ — XellSmart<\/span> Biopharmaceutical (Suzhou\/Shanghai<\/span>) Co., Ltd. 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\u00a0XS228 Cell Injection\u00a0\u2013 the\u00a0world’s first\u00a0“off-the-shelf”, allogeneic, iPSC-derived, spinal neural progenitor cell therapy targeting major neurological disorders, specifically spinal cord injury (SCI) \u2013 has commenced. The clinical trial initiation meeting was held at The Third Affiliated Hospital of Sun Yat<\/span>-sen University (SYSU-3) in Guangzhou<\/span>. Following this, the\u00a0world’s first patient dosing\u00a0with the therapy was successfully administered.<\/b><\/p>\n

Following the world’s first transplantation of clinical-grade, iPSC-derived neural progenitor cells in the registrational clinical trial, the initial subject exhibited no surgical or perioperative complications or other adverse safety events. All monitored parameters remained within normal ranges. The subject successfully completed the observation period uneventfully and has now entered the formal follow-up period.<\/p>\n

XellSmart has achieved a significant milestone in global central nervous system (CNS) injury repair \u2014 having completed the world’s first patient dosing in its China<\/span> registrational clinical trial. This landmark event serves as a benchmark for evaluating the safety of transplanted, iPSC-derived, spinal-cord neural progenitor cells and analyzing their potential therapeutic effects on patients with spinal cord injury (SCI).<\/p>\n

XellSmart is a leading biotechnology company dedicated to developing innovative iPSC-derived cell therapies.\u00a0To date, the company has secured seven Investigational New Drug (IND) approvals from both China’s<\/span> National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) for registrational clinical trials. All approved programs focus on clinical-grade, off-the-shelf, allogeneic, iPSC-derived cell therapies targeting central nervous system (CNS) diseases with significant unmet medical needs, including:<\/p>\n