drugset / Trial / NCT04528550

Autologous Bone Marrow-derived Mononuclear Cells for Acute Spinal Cord Injury

NCT04528550 ↗

Phase 2 Unknown 45 enrolled Shanghai Changzheng Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and effectiveness of intrathecal transplantation of autologous bone marrow-derived mononuclear cells for the treatment of traumatic acute spinal cord injury. Spinal cord injury can be divided into three phases, which are acute (within 2 weeks), sub-acute (2 weeks to 6 months), and chronic (over 6 months). Early treatment is the key to improve the prognosis, however, the majority of clinic trails nowadays are focusing on sub-acute or chronic phase because it takes 4-6 weeks to expand the autologous stem cells. In this study, the investigators will treat patients with acute spinal cord injury with autologous bone marrow-derived mononuclear cells and compare with the control group.

Timeline

Start
2020-10-01
Primary completion
2023-10-01
Completion
2023-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject autologous bone marrow-derived mononuclear cells Cell therapy 1e+08 cells Intrathecal

Indications