NCT01725880

Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects

Long-term Follow-up (LTFU) Study of the Phase I/II Safety and Preliminary Efficacy Investigation of Intramedullary Spinal Cord Transplantation of HuCNS-SC® in Subjects With Thoracic (T2-T11) Spinal Cord Trauma

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: StemCells, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.

Detailed description

The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury. Subjects will be monitored at routine intervals for safety and preliminary efficacy for four years. The LTFU study will commence following the one year post-transplantation termination visit of the Phase I/II investigation.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
OTHER	Observation

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-11-14
• Last updated: 2016-06-03

Locations

1 site across 1 country: Switzerland