drugset / Trial / NCT03505034
Intrathecal Transplantation of UC-MSC in Patients With Late Stage of Chronic Spinal Cord Injury
Phase 2
Unknown
43 enrolled
Third Affiliated Hospital, Sun Yat-Sen University
Shanghai East Hospital · collabWest China Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
This study aim to evaluate the safety and efficacy of intrathecal transplantation of allogeneic umbilical cord derived mesenchymal stem cells (UC-MSC) for treatment of different phrases of spinal cord injury. Here, the history of spinal cord injury is divided into three periods, Sub-acute SCI, Early stage of chronic SCI, and Late stage of chronic SCI, which is 2W-2M, 2M-12M, and more than 12M after injury, respectively. The purpose is to investigate whether the patients with spinal cord injury benefit from UC-MSC transplantation, and then find out the best time for SCI treatment. In this part of the study, the investigators will treat patients with late stage of chronic spinal cord injury with UC-MSC transplantation or placebo.
Timeline
- Start
- 2019-09-01
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | 1e+06 cells/kg | Intrathecal |