Safety and Early Efficacy of iPSC-Derived Motor Neuron Progenitor Cells (XS228) in Subacute Spinal Cord Injury: A Phase I Trial

PHASE1RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

July 2, 2025

Primary Completion Date

February 21, 2028

Study Completion Date

May 30, 2028

Conditions
Spinal Cord InjurySafetyClinical TrialsEfficacyInduced Pluripotent Stem CellsHuman Motor Neuron ProgenitorTransplantation
Interventions
BIOLOGICAL

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."

Trial Locations (1)

510630

RECRUITING

The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou

All Listed Sponsors
collaborator

XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.

INDUSTRY

lead

Third Affiliated Hospital, Sun Yat-Sen University

OTHER