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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321333
• Other study ID #: CL-N02-SC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 21, 2011
• Last updated: June 16, 2015
• Start date: March 2011
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: StemCells, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicCanada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinitis Pigmentosa
• Spinal Cord Injuries
• Spinal Cord Injury
• Spinal Cord Injury Thoracic
• Spinal Cord Trauma
• Thoracic Injuries
• Thoracic Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
Canada	Foothills Medical Center	Calgary	Alberta
Canada	Toronto Western Hospital	Toronto	Ontario
Switzerland	University Hospital Balgrist- Uniklinik Balgrist, Forschstrasse 340	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
StemCells, Inc.

Countries where clinical trial is conducted

Canada,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Types and frequencies of adverse events and serious adverse events	Analysis of types and frequencies of adverse events one year after transplant.	One year after transplant	Yes

External Links

•   Information on study in German- University Hospital Balgrist