Transplantation of Autologous Olfactory Ensheathing Cells NCT01231893

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT01231893
Other study ID #	SR 406
Secondary ID
Status	Recruiting
Phase	Phase 1
First received	October 29, 2010
Last updated	October 29, 2010
Start date	May 2008

Study information
Verified date	October 2010
Source	Wroclaw Medical University
Contact	Pawel Tabakow, M.D. Ph.D.
Phone	48 606 137 846
Email	p.tabakov[@]wp.pl
Is FDA regulated	No
Health authority	Poland: Bioethics Committee
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Recruiting
Enrollment	10
Est. completion date
Est. primary completion date
Accepts healthy volunteers	No
Gender	Both
Age group	16 Years to 65 Years
Eligibility	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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• olfactory mucosa ensheathing cell grafting, rehabilitation
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.

Other:
• rehabilitation
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.

Locations
Country	Name	City	State
Poland	Department of Neurosurgery of Wroclaw Medical University	Wroclaw

Sponsors *(3)*
Lead Sponsor	Collaborator
Wroclaw Medical University	Department of Rehabilitation in Spinal Cord Injuries Akson, Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences

Country where clinical trial is conducted

Poland,

External Links

Link

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

Clinical Trial Details — Status: Recruiting

Administrative data

Study information