Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects
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|ClinicalTrials.gov Identifier: NCT01725880|
Recruitment Status : Terminated (Based on a business decision unrelated to any safety concerns.)
First Posted : November 14, 2012
Last Update Posted : June 3, 2016
|Condition or disease||Intervention/treatment|
|Spinal Cord Injury||Other: Observation|
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 Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||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|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
- American Spinal Injury Association (ASIA) Impairment Scale Improvement [ Time Frame: Four years ]Evidence of improvement in ASIA impairment scale as confirmed by neurological examination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725880
|Zurich, Switzerland, 8008|
|Study Director:||Stephen Huhn, M.D.||StemCells, Inc.|