Status:
UNKNOWN
Transplantation of Autologous Olfactory Ensheathing Cells in Complete Human Spinal Cord Injury
Lead Sponsor:
Wroclaw Medical University
Collaborating Sponsors:
Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
Department of Rehabilitation in Spinal Cord Injuries Akson
Conditions:
Complete Spinal Cord Injuries
Eligibility:
All Genders
16-65 years
Phase:
PHASE1
Brief Summary
The purpose of this experimental therapy is an assessment of the safety and feasibility of transplantation of autologous olfactory ensheathing glia and olfactory fibroblasts obtained from the olfactor...
Detailed Description
The increasing number of patients (mostly young), who have sustained a spinal cord injury mainly as a result of motor vehicle accidents, falls or violence has become worldwide a serious clinical, soci...
Eligibility Criteria
Inclusion
- spinal cord injury at subacute or chronic stage
- a single spinal cord injury between segments C5 and L5
- myelopathy confirmed by MRI, not exceeding 2 spinal cord segments
- loss of sensory and motor function below the injury, confirmed in control studies (ASIA Category A)
- age from 16 to 65 years
- patient undergoing continuous rehabilitation
- good patient motivation and cooperation
- signed informed consent
Exclusion
- a coexisting lesion of the nervous system
- progressive post-traumatic syringomyelia
- significant spinal stenosis or instability
- persistent neuropathic pain
- muscle atrophy or joint ossifications
- severe systemic disease (neoplasm, contagious disease, diabetes etc.)
- chronic sinusitis
- tumors or polyps of nasal cavities
- persistent hyposmia or anosmia
- pregnant or breastfeeding women
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01231893
Start Date
May 1 2008
Last Update
November 1 2010
Active Locations (1)
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1
Department of Neurosurgery of Wroclaw Medical University
Wroclaw, Poland, 50-556