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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
StemCells, Inc.
ClinicalTrials.gov Identifier:
NCT01725880
First received: November 9, 2012
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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 Intervention
Spinal Cord Injury
Other: Observation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by StemCells, Inc.:

Primary Outcome Measures:
  • American Spinal Injury Association (ASIA) Impairment Scale Improvement [ Time Frame: Four years ] [ Designated as safety issue: No ]
    Evidence of improvement in ASIA impairment scale as confirmed by neurological examination


Estimated Enrollment: 12
Study Start Date: November 2012
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
No treatment
Observation
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725880

Locations
Switzerland
Uniklinik Balgrist
Zurich, Switzerland, 8008
Sponsors and Collaborators
StemCells, Inc.
Investigators
Study Director: Stephen Huhn, M.D. StemCells, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: StemCells, Inc.
ClinicalTrials.gov Identifier: NCT01725880     History of Changes
Other Study ID Numbers: CL-N03-SC, TpP_I_2012_002
Study First Received: November 9, 2012
Last Updated: October 15, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by StemCells, Inc.:
Spinal Cord Injury
HuCNS-SC cells
Human Neural Stem Cells
Neural Stem Cells
Stem Cells

Additional relevant MeSH terms:
Retinitis Pigmentosa
Spinal Cord Injuries
Wounds and Injuries
Eye Diseases, Hereditary
Eye Diseases
Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Genetic Diseases, Inborn
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 20, 2014