XellSmart Biopharmaceutical Receives NMPA and FDA Approval for World’s First Clinical Trial of Allogeneic iPSC-Derived Neural Regenerative Cell Therapy for Spinal Cord Injury

SUZHOU, China, May 25, 2025 – XellSmart Biopharmaceutical Co., Ltd. today announced a landmark achievement with the official approval from both China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) for a Phase I clinical trial. This pioneering trial will evaluate XellSmart’s off-the-shelf, allogeneic iPSC-derived subtype-specific neural regenerative cell therapy to treat spinal cord injury (SCI), a severe and currently untreatable central nervous system disease affecting over 15 million patients globally.

This study marks a significant global first as the initial regenerative clinical trial to employ a subtype-specific neural progenitor cell therapeutic product for spinal cord injury. The trial will be spearheaded by the Third Affiliated Hospital of Sun Yat-sen University, a nationally recognized leader in SCI treatment.

Spinal cord injury is a globally prevalent neurological disorder characterized by high rates of disability, irreversibility, early onset, and immense burden on patients, families, and society. Primarily affecting young and middle-aged adults, often due to trauma, SCI leads to profound social challenges and requires lifelong care and rehabilitation, incurring significant economic and societal costs. In high-income countries, lifetime healthcare and caregiving expenses per patient can exceed USD 1 million, placing a heavy strain on public health systems.

With over 15 million individuals worldwide suffering from SCI, including over 3 million in China and 300,000 in the U.S., the need for effective therapies is urgent. Each year, China and the U.S. report approximately 100,000 and 18,000 new cases of acute or subacute SCI, respectively.

SCI typically results in partial or complete paralysis, with permanent loss of motor and sensory function, severely compromising quality of life. Due to the central nervous system’s limited regenerative capacity, nerve repair after SCI remains extremely challenging. Current treatments are largely limited to rehabilitation and supportive care, with no effective therapies currently available to promote neural regeneration during the injury phase.

Following over four years of rigorous development and preclinical studies, XellSmart has partnered with leading clinical experts to launch this world-first registrational clinical trial. This pioneering initiative represents a landmark achievement in the global effort to develop regenerative therapies for spinal cord injury. XellSmart is committed to advancing breakthrough treatments, aiming to redefine possibilities for SCI recovery and bring new hope to patients in China and around the world, delivering tangible relief to affected families and communities.