Thoracic Spinal Cord InjuryPhase 1/2NCT01321333
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury
A Phase 1/2 study testing HuCNS-SC cells in people with Thoracic Spinal Cord Injury and Spinal Cord Injury, run by StemCells, Inc. at 3 sites in 2 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thoracic Spinal Cord Injury, Spinal Cord Injury, Spinal Cord Injury Thoracic
- What is being tested?
- HuCNS-SC cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2011to Apr 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Foothills Medical Center
Calgary, Alberta, T2N-2T9
Toronto Western Hospital
Toronto, Ontario
Switzerland1 site
University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340
Zurich, Canton of Zurich, 8008
About this study
Official title: 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
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.
- Conditions
- Thoracic Spinal Cord Injury, Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Trauma
- Being tested
- HuCNS-SC cells
- 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
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuCNS-SC cellsBiological
Also called Human central nervous system stem cells, allogeneic stem cells
single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord
| Study group | Role | What they receive |
|---|---|---|
| HuCNS-SC cells | Experimental | Single dose intramedullary administration of HuCNS-SC cells Receives: Biological: HuCNS-SC cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types and frequencies of adverse events and serious adverse events
Analysis of types and frequencies of adverse events one year after transplant.
Measured: One year after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- StemCells, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Huhn, MD, Study chair, StemCells, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321333
- Sponsor's protocol ID
- CL-N02-SC
- Status last verified
- Jun 2015
- First submitted
- 21 Mar 2011
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01321333
- Acronym / sponsor ID
- CL-N02-SC
- Conditions
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- StemCells, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HuCNS-SC cells | Experimental | Biological: HuCNS-SC cellsSingle dose intramedullary administration of HuCNS-SC cells |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HuCNS-SC cellsAlso: Human central nervous system stem cells, allogeneic stem cellssingle dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord | Biological | HuCNS-SC cells |
Primary outcome
Types and frequencies of adverse events and serious adverse events
Time frame: One year after transplant
Analysis of types and frequencies of adverse events one year after transplant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Huhn, MD study chair
StemCells, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HuCNS-SC cells in people with Thoracic Spinal Cord Injury and Spinal Cord Injury, run by StemCells, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Types and frequencies of adverse events and serious adverse events (time frame: One year after transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2015.