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

Terminated

• Conditions: Spinal Cord Injury

• Registration Number: NCT01725880
• Lead Sponsor: StemCells, Inc.

Brief 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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-09
• Study First Submitted QC: 2012-11-09
• Study First Posted: 2012-11-14
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial
• Must agree to comply in good faith with all conditions of the study and to attend all required study visits

Exclusion Criteria

• Subjects have received or are receiving off-protocol immunosuppressive medications
• Subjects who, after completion of Phase I/II trial (Protocol # CL-N02-SC), have entered or are about to enter any other investigational study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
American Spinal Injury Association (ASIA) Impairment Scale Improvement	Four years	Evidence of improvement in ASIA impairment scale as confirmed by neurological examination

Trial Locations

Locations (1)

Uniklinik Balgrist; 🇨🇭 Zurich, Switzerland