NCT04528550

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

Intrathecal Transplantation of Autologous Bone Marrow-derived Mononuclear Cells for Treating Traumatic Acute Spinal Cord Injury

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
BIOLOGICAL	Autologous bone marrow-derived mononuclear cells	Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.
DRUG	Placebo	Included patients will receive the same amount of saline through lumbar injection.

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2020-08-27
• Last updated: 2021-07-07

Locations

1 site across 1 country: China