Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury

StemCells, Inc

Status and phase

Completed

Phase 2

Phase 1

Conditions

Spinal Cord Injury Thoracic

Spinal Cord Trauma

Thoracic Spinal Cord Injury

Spinal Cord Injury

Treatments

Biological: HuCNS-SC cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT01321333

CL-N02-SC

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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