NCT02163876
Terminated
Phase 2
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
InterventionsHuCNS-SC cells
DrugsHuCNS-SC cells
Overview
- Phase
- Phase 2
- Intervention
- HuCNS-SC cells
- Conditions
- Cervical Spinal Cord Injury
- Sponsor
- StemCells, Inc.
- Enrollment
- 31
- Locations
- 14
- Primary Endpoint
- Change from baseline in ISNCSCI upper extremity motor scores
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
HuCNS-SC cells
Intramedullary transplantation of HuCNS-SC cells in the cervical spine
Intervention: HuCNS-SC cells
Outcomes
Primary Outcomes
Change from baseline in ISNCSCI upper extremity motor scores
Time Frame: Up to one year after enrollment
Secondary Outcomes
- Number of participants with serious and non-serious adverse events(Up to one year from the time of enrollment)
Study Sites (14)
Loading locations...
Similar Trials
Unknown
Phase 1
Intracerebral Transplantation of Neural Stem Cells for the Treatment of Ischemic StrokeIschemic Motor Stroke, ChronicNCT03296618Suzhou Neuralstem Biopharmaceuticals18
Unknown
Phase 1
Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCISpinal Cord Injury (SCI)NCT01772810Neuralstem Inc.8
Completed
Phase 1
Neural Stem Cell Transplantation in Multiple Sclerosis PatientsProgressive Multiple SclerosisNCT03269071IRCCS San Raffaele4
Completed
Not Applicable
Clinical trial of human neural stem cell transplantation in patients with severe perinatal hypoxic-ischemic brain injuryPregnancy, childbirth and the puerperiumKCT0001429Yonsei University Health System, Severance Hospital41
Withdrawn
Phase 1
Safety and Efficacy Study of HuCNS-SC in Subjects With Neuronal Ceroid LipofuscinosisNeuronal Ceroid LipofuscinosisNCT01238315StemCells, Inc.