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
Description
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.
Phase
Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.Inclusion and Exclusion 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
- 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
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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