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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01321333

Enrollment

Registered

2011-03-23

Start date

2011-03-31

Completion date

2015-04-30

Last updated

2015-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Trauma, Thoracic Spinal Cord Injury

Keywords

thoracic spinal cord injury, spinal cord injury thoracic, sub-acute spinal cord injury, human neural stem cells, stem cells, stem cells transplant, stem cells transplant spinal cord injury

Brief 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.

Interventions

BIOLOGICALHuCNS-SC cells

single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* T2-T11 thoracic spinal cord injury based on American Spinal Injury Association (ASIA) level determination by the principal investigator (PI) * T2-T11 thoracic spinal cord injury as assessed by magnetic resonance imaging (MRI) and/or computerized tomography (CT) * ASIA Impairment Scale (AIS) Grade A, B, or C * Minimum of six weeks post injury for the initiation of screening * Must have evidence of preserved conus function * Must be at stable stage of medical recovery after injury

Exclusion criteria

* History of traumatic brain injury without recovery * Penetrating spinal cord injury * Evidence of spinal instability or persistent spinal stenosis and/or compression related to initial trauma * Previous organ, tissue or bone marrow transplantation * Previous participation in any gene transfer or cell transplant trial * Current or prior malignancy

Design outcomes

Primary

Measure	Time frame	Description
Types and frequencies of adverse events and serious adverse events	One year after transplant	Analysis of types and frequencies of adverse events one year after transplant.

Countries

Canada, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026