NCT01471613

Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury

Safety and Effect of Lithium, Umbilical Cord Blood Cells and the Combination in the Treatment of Acute and Sub-acute Spinal Cord Injury : a Randomized, Double-Blinded Placebo-Controlled Clinical Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: China Spinal Cord Injury Network · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The trial is to investigate the safety and efficacy of oral lithium, intraspinal umbilical cord blood mononuclear cell transplant, and the combination in the treatment of acute and subacute spinal cord injury

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
PROCEDURE	Conventional Treatment	Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
DRUG	Lithium Carbonate Tablet	250mg/tablet, administrated orally for 6 weeks.
BIOLOGICAL	Cord Blood Cell	Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site
OTHER	Placebo	Placebo tablet, orally administration of placebo for 6 weeks

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-12-01
• Completion: 2014-01-01
• First posted: 2011-11-15
• Last updated: 2014-01-28

Locations

1 site across 1 country: China