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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Wroclaw Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
Department of Rehabilitation in Spinal Cord Injuries Akson
Information provided by:
Wroclaw Medical University
ClinicalTrials.gov Identifier:
NCT01231893
First received: October 29, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Complete Spinal Cord Injuries
Procedure: olfactory mucosa ensheathing cell grafting, rehabilitation
Other: rehabilitation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation of Autologous Olfactory Ensheathing Cells for Treatment of Complete Human Spinal Cord Injuries- a Phase I Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Wroclaw Medical University:

Estimated Enrollment: 10
Study Start Date: May 2008
Arms Assigned Interventions
Experimental: olfactory ensheathing cell recipient 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.
Active Comparator: control 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.

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

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231893

Contacts
Contact: Pawel Tabakow, M.D. Ph.D. 48 606 137 846 p.tabakov@wp.pl
Contact: Wlodzimierz Jarmundowicz, M.D. Ph.D. 48 601 706 816 jarmund@wp.pl

Locations
Poland
Department of Neurosurgery of Wroclaw Medical University Recruiting
Wroclaw, Poland, 50-556
Principal Investigator: Pawel Tabakow, M.D. Ph.D.         
Sub-Investigator: Wlodzimierz Jarmundowicz, M.D. Ph.D.         
Sub-Investigator: Bogdan Czapiga, M.D. Ph.D.         
Sub-Investigator: Ryszard Miedzybrodzki, M.D. Ph.D.         
Sub-Investigator: Wojciech Fortuna, M.D. Ph. D.         
Sub-Investigator: Marcin Czyz, M. D. Ph. D.         
Sub-Investigator: Dariusz Szarek, M.D.         
Sub-Investigator: Stefan Okurowski, MPT         
Sub-Investigator: Juliusz Huber, M.D. Ph. D.         
Sub-Investigator: Pawel Szewczyk, M.D.         
Sponsors and Collaborators
Wroclaw Medical University
Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
Department of Rehabilitation in Spinal Cord Injuries Akson
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Prof. Wlodzimierz Jarmundowicz, Department of Neurosurgery of the Wroclaw Medical University
ClinicalTrials.gov Identifier: NCT01231893     History of Changes
Other Study ID Numbers: SR 406
Study First Received: October 29, 2010
Last Updated: October 29, 2010
Health Authority: Poland: Bioethics Committee

Keywords provided by Wroclaw Medical University:
human, spinal cord injury, olfactory ensheathing cells, transplantation

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 11, 2014