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

This study has been terminated.

(Based on a business decision unrelated to any safety concerns.)

Sponsor:

Information provided by (Responsible Party):

StemCells, Inc.

ClinicalTrials.gov Identifier:

NCT01725880

First received: November 9, 2012

Last updated: June 1, 2016

Last verified: May 2016

History of Changes

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:

MedlinePlus related topics: Spinal Cord Injuries Wounds and Injuries

U.S. FDA Resources

Further study details as provided by StemCells, Inc.:

Primary Outcome Measures:

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


Enrollment:	12
Study Start Date:	November 2012
Study Completion Date:	May 2016
Primary Completion Date:	May 2016 (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 (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

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


Responsible Party:	StemCells, Inc.
ClinicalTrials.gov Identifier:	NCT01725880 History of Changes
Other Study ID Numbers:	CL-N03-SC TpP_I_2012_002 ( Other Identifier: SwissMedic )
Study First Received:	November 9, 2012
Last Updated:	June 1, 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:


Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases	Nervous System Diseases Trauma, Nervous System Wounds and Injuries

ClinicalTrials.gov processed this record on July 21, 2017

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