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

June 1, 2016 updated by: StemCells, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • Uniklinik Balgrist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No treatment
Observation
Other: Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Spinal Injury Association (ASIA) Impairment Scale Improvement
Time Frame: Four years
Evidence of improvement in ASIA impairment scale as confirmed by neurological examination
Four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

StemCells, Inc.

Investigators

  • Study Director: Stephen Huhn, M.D., StemCells, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

November 9, 2012

First Submitted That Met QC Criteria

November 9, 2012

First Posted (Estimate)

November 14, 2012

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 1, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-N03-SC
  • TpP_I_2012_002 (Other Identifier: SwissMedic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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