Transplantation of Autologous Olfactory Ensheathing Cells in Complete Human Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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, social and economical problem. Most accepted treatment protocols for spinal cord injury focus on techniques of early neuro-protection aimed at maximal prevention of secondary spinal cord injury (administration of methylprednisolon and spinal cord surgical decompression) as well as on methods of stimulation of plasticity in the central nervous system (neurorehabilitation). While these methods have been shown to stimulate functional recovery in patients with incomplete spinal cord injury, the results of treatment of patients with severe incomplete and complete spinal cord injuries remain unsatisfactory. This is due to the lack of spontaneous regeneration of lesioned axons in the spinal cord. Results from a substantial number of animal experiments performed mainly on the model of mammalian spinal cord injury in the last 3 decades led to the establishment of numerous regeneration-promoting strategies including application of neurotrophic factors, antibodies blocking the myelin-associated proteins and transplantation of cells with neurotrophic activity. Olfactory ensheathing cells (OECs) are an unique population of macroglia found in the lamina propria of olfactory mucosa, around the olfactory nerve fascicles and in the two outer layers of the olfactory bulb. These cells have the natural ability to stimulate the regrowth of lesioned peripheral and central axons. In a Phase I non-randomized controlled prospective study we have tested the hypothesis that a combined approach for treatment of complete spinal cord injuries consisting of intraspinal transplantation of a mixture of autologous OECs and fibroblasts isolated from the olfactory mucosa, combined with intense neuro-rehabilitation is safe and feasible.

Official Title
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Transplantation of Autologous Olfactory Ensheathing Cells for Treatment of Complete Human Spinal Cord Injuries- a Phase I Clinical Trial.

Conditions
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Complete Spinal Cord Injuries

Intervention / Treatment
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* Procedure: olfactory mucosa ensheathing cell grafting, rehabilitation
* Other: rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: olfactory ensheathing cell recipient<br> | Procedure: olfactory mucosa ensheathing cell grafting, rehabilitation<br>* 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.<br>|
| Active Comparator: control<br> | Other: rehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human, spinal cord injury, olfactory ensheathing cells, transplantation