Clinical trial NCT01231893: Transplantation of Autologous Olfactory Ensheathing Cells in Complete Human Spinal Cord Injury
Official title: Transplantation of Autologous Olfactory Ensheathing Cells for Treatment of Complete Human Spinal Cord Injuries- a Phase I Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Complete Spinal Cord Injuries
Keywords: human, spinal cord injury, olfactory ensheathing cells, transplantation
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
Collaborators: name: Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
name: Department of Rehabilitation in Spinal Cord Injuries Akson
First posted: 2010-11-01
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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, 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Department of Neurosurgery of Wroclaw Medical University
Study officials:
affiliation: Department of Neurosurgery of Wroclaw Medical University
name: Wlodzimierz Jarmundowicz, M.D. Ph.D.
role: STUDY_DIRECTOR
affiliation: Department of Neurosurgery of Wroclaw Medical University
name: Pawel Tabakow, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: