12
Participants
Start Date
July 2, 2025
Primary Completion Date
February 21, 2028
Study Completion Date
May 30, 2028
Allogeneic Human Induced Pluripotent Stem Cell (iPSC)-Derived Motor Neuron Progenitor Cells
"Description:~The Single Ascending Dose (SAD) and Muliple Ascending Dose (MAD) stages were built up in the study. XS228 in SAD and MAD following intrathecal injection through lumbar puncture in subacute spinal cord Injury participants.For SAD,the participants will single intrathecal injection with the dose level as 5×10\^7 cells 、1.5×10\^8 cells. For MAD, the participants will intrathecal injection of XS228 in Day 1, Day15, Day 29, Day 43 under the dose level of 5×10\^7 cells、1.5×10\^8 cells.Dose escalation followed a rule-based 3+3 design.~XS228 is an investigational, allogeneic cell therapy product composed of motor neuron progenitor cells (MNPCs) derived from human induced pluripotent stem cells (iPSCs). This advanced therapy medicinal product (ATMP) is being developed for the treatment of subacute spinal cord injury and represents a novel approach in regenerative medicine."
RECRUITING
The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
INDUSTRY
Third Affiliated Hospital, Sun Yat-Sen University
OTHER