Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury

A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of Human Central Nervous System Stem Cells (HuCNS-SC) Transplantation in Cervical Spinal Cord Injury

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02163876

Enrollment

Registered

2014-06-16

Start date

2014-10-31

Completion date

2016-05-31

Last updated

2016-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Spinal Cord Injury, Cervical Spine Injury, Spine Injury

Keywords

spine, injury, trauma, spine injury, cervical spine injury, cervical spine, stemcells transplantation

Brief summary

This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.

Interventions

DRUGHuCNS-SC cells

surgery arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Male or female subjects age 18 to 60 years. * Traumatic cervical spinal cord injury (cSCI) with C5-C7 motor levels according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) as determined by the Investigator. * American Spinal Injury Association Impairment Scale (AIS) Grades B or C * Minimum of 12 weeks post-injury prior to Screening

Exclusion criteria

* History of penetrating SCI. * MRI evidence of complete spinal cord interruption . * Evidence of spinal instability, stenosis and/or persistent cord compression related to the initial trauma. * Prior participation in another investigational study within 90 days prior to Screening. * Previous organ, tissue, bone marrow transplantation, or gene transfer * History of malignancy (except non-melanoma skin cancers) that require(d) radiation and/or chemotherapy

Design outcomes

Primary

Measure	Time frame
Change from baseline in ISNCSCI upper extremity motor scores	Up to one year after enrollment

Secondary

Measure	Time frame	Description
Number of participants with serious and non-serious adverse events	Up to one year from the time of enrollment	Safety measures will include collection of adverse events, laboratory tests, neurological examination, ISNCSCI motor and sensory scores, pain and allodynia assessment, AIS grade, physical examination and modified Ashworth scale

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026