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Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects

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ClinicalTrials.gov Identifier: NCT01725880
Recruitment Status : Terminated (Based on a business decision unrelated to any safety concerns.)
First Posted : November 14, 2012
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
StemCells, Inc.

Study Description
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Brief Summary:
The purpose of this study is to determine the long term safety and preliminary efficacy of intramedullary transplantation of HuCNS-SC cells in subjects with thoracic spinal cord trauma.

Condition or disease Intervention/treatment
Spinal Cord Injury Other: Observation

Detailed Description:

The investigation is a multi-year observational study following the completion of the open-label, single dose Phase I/II study involving transplantation of allogeneic HuCNS-SC cells into 12 subjects with thoracic spinal cord injury.

Subjects will be monitored at routine intervals for safety and preliminary efficacy for four years. The LTFU study will commence following the one year post-transplantation termination visit of the Phase I/II investigation.

Study Design
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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Follow-up (LTFU) Study of the Phase I/II Safety and Preliminary Efficacy Investigation of Intramedullary Spinal Cord Transplantation of HuCNS-SC® in Subjects With Thoracic (T2-T11) Spinal Cord Trauma
Study Start Date : November 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

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Groups and Cohorts
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Group/Cohort Intervention/treatment
No treatment
Observation
 Other: Observation


Outcome Measures
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Primary Outcome Measures :
  1. American Spinal Injury Association (ASIA) Impairment Scale Improvement [ Time Frame: Four years ]
    Evidence of improvement in ASIA impairment scale as confirmed by neurological examination


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who had undergone intramedullary transplantation of HuCNS-SC cells in the thoracic region.
Criteria

Inclusion Criteria:

  • Must have undergone HuCNS-SC transplantation as a subject in the Phase I/II trial
  • Must agree to comply in good faith with all conditions of the study and to attend all required study visits

Exclusion Criteria:

  • Subjects have received or are receiving off-protocol immunosuppressive medications
  • Subjects who, after completion of Phase I/II trial (Protocol # CL-N02-SC), have entered or are about to enter any other investigational study.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01725880


Locations
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Switzerland
Uniklinik Balgrist
Zurich, Switzerland, 8008
Sponsors and Collaborators
StemCells, Inc.
Investigators
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Study Director: Stephen Huhn, M.D. StemCells, Inc.
More Information
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Responsible Party: StemCells, Inc.
ClinicalTrials.gov Identifier: NCT01725880    
Other Study ID Numbers: CL-N03-SC
TpP_I_2012_002 ( Other Identifier: SwissMedic )
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: May 2016
Keywords provided by StemCells, Inc.:
Spinal Cord Injury
HuCNS-SC cells
Human Neural Stem Cells
Neural Stem Cells
Stem Cells
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries