Transplantation of Autologous Olfactory Ensheathing Cells in Complete Human Spinal Cord Injury
1 other identifier
interventional
10
1 country
1
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 olfactory mucosa in patients with complete spinal cord injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 29, 2010
CompletedFirst Posted
Study publicly available on registry
November 1, 2010
CompletedNovember 1, 2010
October 1, 2010
October 29, 2010
October 29, 2010
Conditions
Keywords
Study Arms (2)
olfactory ensheathing cell recipient
EXPERIMENTALcontrol
ACTIVE COMPARATORInterventions
In this group patients are planned to underwent a biopsy of their own olfactory mucosa for isolation and culture of olfactory ensheathing cells and olfactory fibroblasts. The suspension of these cells will be next transplanted into the focus of spinal cord injury. Before and after surgery the patients will undergo an intense neurorehabilitation program.
In this group the patients will not undergo any surgical procedure. They will participate in the same rehabilitation protocol that is planned for the patients from the experimental group.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Neurosurgery of Wroclaw Medical University
Wroclaw, 50-556, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wlodzimierz Jarmundowicz, M.D. Ph.D.
Department of Neurosurgery of Wroclaw Medical University
- PRINCIPAL INVESTIGATOR
Pawel Tabakow, M.D. Ph.D.
Department of Neurosurgery of Wroclaw Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 29, 2010
First Posted
November 1, 2010
Study Start
May 1, 2008
Last Updated
November 1, 2010
Record last verified: 2010-10