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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cervical Spinal Cord Injury, Spine Injury, Cervical Spine Injury

Intervention / Treatment
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* Drug: HuCNS-SC cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HuCNS-SC cells<br>Intramedullary transplantation of HuCNS-SC cells in the cervical spine | Drug: HuCNS-SC cells<br>* surgery arm<br>* Other names: HCNS-SC;|
| No Intervention: non-surgery arm<br>non-surgery arm | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in ISNCSCI upper extremity motor scores |  | Up to one year after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with serious and non-serious adverse events | 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 | Up to one year from the time of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spine, injury, trauma, spine injury, cervical spine injury, cervical spine, stemcells transplantation