Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01231893
Recruitment Status : Unknown
Verified October 2010 by Wroclaw Medical University.
Recruitment status was:  Recruiting
First Posted : November 1, 2010
Last Update Posted : November 1, 2010
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

Tracking Information
First Submitted Date  ICMJE October 29, 2010
First Posted Date  ICMJE November 1, 2010
Last Update Posted Date November 1, 2010
Study Start Date  ICMJE May 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transplantation of Autologous Olfactory Ensheathing Cells in Complete Human Spinal Cord Injury
Official Title  ICMJE Transplantation of Autologous Olfactory Ensheathing Cells for Treatment of Complete Human Spinal Cord Injuries- a Phase I Clinical Trial.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Complete Spinal Cord Injuries
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: olfactory ensheathing cell recipient
    Intervention: Procedure: olfactory mucosa ensheathing cell grafting, rehabilitation
  • Active Comparator: control
    Intervention: Other: rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October¬†29,¬†2010)
10
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01231893
Other Study ID Numbers  ICMJE SR 406
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Wlodzimierz Jarmundowicz, Department of Neurosurgery of the Wroclaw Medical University
Study Sponsor  ICMJE Wroclaw Medical University
Collaborators  ICMJE
  • Institute of Immunology and Experimental Therapy of the Polish Academy of Sciences
  • Department of Rehabilitation in Spinal Cord Injuries Akson
Investigators  ICMJE
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
PRS Account Wroclaw Medical University
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP