NCT01321333

Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury

A Phase I/II Study of the Safety and Preliminary Efficacy of Intramedullary Spinal Cord Transplantation of Human Central Nervous System (CNS) Stem Cells (HuCNS-SC®) in Subjects With Thoracic (T2-T11) Spinal Cord Trauma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: StemCells, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the effect of single transplantation of HuCNS-SC cells into the thoracic spinal cord of patients with sub-acute spinal cord injury.

Detailed description

Study subjects will receive immunosuppression for nine months following transplantation. All enrolled subjects will be followed for one year following transplantation and then will be enrolled in a separate long-term follow-up study for an additional four years.

Conditions

• Thoracic Spinal Cord Injury
• Spinal Cord Injury
• Spinal Cord Injury Thoracic
• Spinal Cord Trauma

Interventions

Type	Name	Description
BIOLOGICAL	HuCNS-SC cells	single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord

Timeline

• Start date: 2011-03-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2011-03-23
• Last updated: 2015-06-18

Locations

3 sites across 2 countries: Canada, Switzerland