03/06/2025
Chinese biotech company XellSmart has received approval from both the U.S. FDA and China’s NMPA to start a Phase I clinical trial for a new spinal cord injury treatment.
The therapy uses donor stem cells (not from the patient) to help regenerate damaged spinal tissue, aiming to restore function—not just manage symptoms like older treatments.
The trial is being done with Sun Yat-sen University's Third Affiliated Hospital, a top center for spinal cord research.
This first phase will test the treatment’s safety, effectiveness, and proper dosage. If it goes well, larger trials will follow, and the therapy could be available in 5 to 7 years.