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

October 29, 2010 updated by: Wroclaw Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pawel Tabakow, M.D. Ph.D.
  • Phone Number: 48 606 137 846
  • Email: p.tabakov@wp.pl

Study Contact Backup

  • Name: Wlodzimierz Jarmundowicz, M.D. Ph.D.
  • Phone Number: 48 601 706 816
  • Email: jarmund@wp.pl

Study Locations

  • Poland
      • Wroclaw, Poland, 50-556
        • Recruiting
        • Department of Neurosurgery of Wroclaw Medical University
        • 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 Międzybrodzki, 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Study Registration Dates

First Submitted

October 29, 2010

First Submitted That Met QC Criteria

October 29, 2010

First Posted (Estimate)

November 1, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2010

Last Update Submitted That Met QC Criteria

October 29, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SR 406

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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