drugset / Trial / NCT03521336
Intrathecal Transplantation of UC-MSC in Patients With Sub-Acute Spinal Cord Injury
Phase 2
Unknown
84 enrolled
Third Affiliated Hospital, Sun Yat-Sen University
Shanghai East Hospital · collabWest China Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
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 sub-acute 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 |