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CompletedNCT01321333Updated Jun 18, 2015

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

A Phase 1/2 interventional study of HuCNS-SC cells in Thoracic Spinal Cord Injury, Spinal Cord Injury and Spinal Cord Injury Thoracic, sponsored by StemCells, Inc.. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-06-18.

Sponsored by StemCells, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thoracic Spinal Cord Injury
  • Spinal Cord Injury
  • Spinal Cord Injury Thoracic
  • Spinal Cord Trauma

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
03

In context

Spinal Cord Injuries

1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.

This study's enrollment of 12 is below the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

StemCells, Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    HuCNS-SC cells

    Single dose intramedullary administration of HuCNS-SC cells

    Biological: HuCNS-SC cells

Interventions

  • BiologicalHuCNS-SC cells

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

    Also known as: Human central nervous system stem cells, allogeneic stem cells

06

What researchers measure

Primary outcomes

  1. Types and frequencies of adverse events and serious adverse events

    Analysis of types and frequencies of adverse events one year after transplant.

    Time frame: One year after transplant

07

Study locations

3 sites
  • Foothills Medical Center
    Calgary, Alberta T2N-2T9, Canada
  • Toronto Western Hospital
    Toronto, Ontario, Canada
  • University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340
    Zurich, Canton of Zurich 8008, Switzerland
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2011
First posted
Mar 23, 2011
Start
Mar 2011
Primary completionActual
Apr 2015
CompletionActual
Apr 2015
Last update
Jun 18, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01321333
Lead sponsor
StemCells, Inc.
Responsible party
Sponsor
First posted
Mar 23, 2011
Start date
Mar 2011
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Jun 18, 2015

Study contacts

Stephen Huhn, MD
study chair · StemCells, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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