US EditionSRIHER Spine Surgery Team Wins Research Award in Seoul
- In May 2025, XellSmart Biopharmaceutical announced approval for a Phase I trial of an off-the-shelf iPSC-derived neural cell therapy targeting spinal cord injury .
- This approval followed over four years of development to address SCI, a severe and currently untreatable central nervous system disease affecting over 15 million people worldwide.
- The global first Phase I clinical trial using subtype-specific neural progenitor cells for spinal cord injury treatment is being conducted under the direction of the renowned spinal cord injury center affiliated with Sun Yat-sen University.
- SCI primarily impacts young and middle-aged adults, causes irreversible disability, and imposes lifetime healthcare costs exceeding USD 1 million per patient in high-income countries.
- XellSmart's initiative, with approvals from China’s NMPA and the U.S. FDA and extensive clinical trials across CNS diseases, aims to pioneer new treatments and redefine recovery possibilities for SCI patients worldwide.
76 Articles
76 Articles
Rutland Herald
World's First -- XellSmart's Allogeneic iPSC-derived Regenerative Cell Therapy for Spinal Cord Injury Officially Approved by the U.S. FDA for a Registrational Phase I Clinical Trial
SUZHOU, China, May 25, 2025 /PRNewswire/ -- In May 2025, XellSmart Biopharmaceutical (Suzhou/Shanghai) Co., Ltd. officially announced that XellSmart-developed off-the-shelf allogeneic iPSC-derived subtype-specific neural regenerative cell therapy has received official approval from both China's National Medical Products Administration (NMPA) and…
XellSmart’s iPSC Therapy for Spinal Injury Approved for Phase I Trial by U.S. FDA
SUZHOU, China, May 26, 2025 /PRNewswire/ -- In May 2025, XellSmart Biopharmaceutical (Suzhou/Shanghai) Co., Ltd. officially announced that XellSmart-developed off-the-shelf allogeneic iPSC-derived subtype-specific neural regenerative cell therapy has received 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, to treat spinal cord injury…
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