NCT01772810

Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI

A Phase 1, Open-label, Single-site, Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Neuralstem Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury.

Detailed description

Phase I, open-label, single-site, safety study of HSSC transplantation for the treatment of chronic spinal cord injury (SCI). Group A enrolled 4 subjects with a cord injury at T2-T12; Group B will enroll 4 subjects with a C5-C7 cord injury. Study period will be 6 months post-operative. Post-study, subjects will be followed for an additional 54 months.

Conditions

• Spinal Cord Injury (SCI)

Interventions

Type	Name	Description
DRUG	Human spinal cord stem cells.	Human spinal cord stem cell implantation in paralysis patients due to a spinal cord injury.

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-07-01
• Completion: 2022-12-01
• First posted: 2013-01-21
• Last updated: 2017-09-11

Locations

1 site across 1 country: United States