NCT01725880

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

May 1, 2016

Enrollment Period

3.5 years

First QC Date

November 9, 2012

Last Update Submit

June 1, 2016

Conditions

Spinal Cord Injury

Keywords

Spinal Cord InjuryHuCNS-SC cellsHuman Neural Stem CellsNeural Stem CellsStem Cells

Outcome Measures

Primary Outcomes (1)

  • American Spinal Injury Association (ASIA) Impairment Scale Improvement

    Evidence of improvement in ASIA impairment scale as confirmed by neurological examination

    Four years

Study Arms (1)

No treatment

Observation

Other: Observation

Interventions

ObservationOTHER
No treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who had undergone intramedullary transplantation of HuCNS-SC cells in the thoracic region.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniklinik Balgrist

Zurich, 8008, Switzerland

Location

Related Links

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Observation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Stephen Huhn, M.D.

    StemCells, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2012

First Posted

November 14, 2012

Study Start

November 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-05

Locations

CH(1)