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Autologous olfactory ensheathing cell transplantation in human paraplegia : a 3-year clinical trial. Commentary

Identifieur interne : 008E61 ( Main/Exploration ); précédent : 008E60; suivant : 008E62

Autologous olfactory ensheathing cell transplantation in human paraplegia : a 3-year clinical trial. Commentary

Auteurs : Volker Dietz [Suisse] ; A. Mackay-Sim [Australie] ; F. Feron [Australie, France] ; J. Cochrane [Australie] ; L. Bassingthwaighte [Australie] ; C. Bayliss [Australie] ; W. Davies [Australie] ; P. Fronek [Australie] ; C. Gray [Australie] ; G. Kerr [Australie] ; P. Licina [Australie] ; A. Nowitzke [Australie] ; C. Perry [Australie] ; P. A. S. Silburn [Australie] ; S. Urquhart [Australie] ; T. Geraghty [Australie]

Source :

RBID : Pascal:08-0417141

Descripteurs français

English descriptors

Abstract

Olfactory ensheathing cells show promise in preclinical animal models as a cell transplantation therapy for repair of the injured spinal cord. This is a report of a clinical trial of autologous transplantation of olfactory ensheathing cells into the spinal cord in six patients with complete, thoracic paraplegia. We previously reported on the methods of surgery and transplantation and the safety aspects of the trial I year after transplantation. Here we address the overall design of the trial and the safety of the procedure, assessed during a period of 3 years following the transplantation surgery. All patients were assessed at entry into the trial and regularly during the period of the trial. Clinical assessments included medical, psychosocial, radiological and neurological, as well as specialized tests of neurological and functional deficits (standard American Spinal Injury Association and Functional Independence Measure assessments). Quantitative test included neurophysiological tests of sensory and motor function below the level of injury. The trial was a Phase 1/lla design whose main aim was to test the feasibility and safety of transplantation of autologous olfactory ensheathing cells into the injured spinal cord in human paraplegia. The design included a control group who did not receive surgery, otherwise closely matched to the transplant recipient group. This group acted as a control for the assessors, who were blind to the treatment status of the patients. The control group also provided the opportunity for preliminary assessment of the efficacy of the transplantation.There were no adverse findings 3 years after autologous transplantation of olfactory ensheathing cells into spinal cords injured at least 2 years prior to transplantation.The magnetic resonance images (MRls) at 3 years showed no change from preoperative MRls or intervening MRls at I and 2 years, with no evidence of any tumour of introduced cells and no development of post-traumatic syringomyelia or other adverse radiological findings.There were no significant functional changes in any patients and no neuropathic pain. In one transplant recipient, there was an improvement over 3 segments in light touch and pin prick sensitivity bilaterally, anteriorly and posteriorly. We conclude that transplantation of autologous olfactory ensheathing cells into the injured spinal cord is feasible and is safe up to 3 years of post-implantation, however, this conclusion should be considered preliminary because of the small number of trial patients.


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Le document en format XML

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<title xml:lang="en" level="a">Autologous olfactory ensheathing cell transplantation in human paraplegia : a 3-year clinical trial. Commentary</title>
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<name sortKey="Dietz, Volker" sort="Dietz, Volker" uniqKey="Dietz V" first="Volker" last="Dietz">Volker Dietz</name>
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<s2>Woolloongabba, Qld 4102</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Woolloongabba, Qld 4102</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Silburn, P A S" sort="Silburn, P A S" uniqKey="Silburn P" first="P. A. S." last="Silburn">P. A. S. Silburn</name>
<affiliation wicri:level="1">
<inist:fA14 i1="02">
<s1>National Centre for Adult Stem cell Research, Eskitis Institute for Cell and MolecularTherapies, Griffith University</s1>
<s2>Brisbane, Qld 4111</s2>
<s3>AUS</s3>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Brisbane, Qld 4111</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Urquhart, S" sort="Urquhart, S" uniqKey="Urquhart S" first="S." last="Urquhart">S. Urquhart</name>
<affiliation wicri:level="1">
<inist:fA14 i1="06">
<s1>Spinal Injuries Unit, Queensland Spinal Cord Injuries Service, Princess Alexandra Hospital</s1>
<s2>Woolloongabba, Qld 4102</s2>
<s3>AUS</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Woolloongabba, Qld 4102</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Geraghty, T" sort="Geraghty, T" uniqKey="Geraghty T" first="T." last="Geraghty">T. Geraghty</name>
<affiliation wicri:level="1">
<inist:fA14 i1="06">
<s1>Spinal Injuries Unit, Queensland Spinal Cord Injuries Service, Princess Alexandra Hospital</s1>
<s2>Woolloongabba, Qld 4102</s2>
<s3>AUS</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Woolloongabba, Qld 4102</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Brain</title>
<title level="j" type="abbreviated">Brain</title>
<idno type="ISSN">0006-8950</idno>
<imprint>
<date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Brain</title>
<title level="j" type="abbreviated">Brain</title>
<idno type="ISSN">0006-8950</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Autologous system</term>
<term>Clinical trial</term>
<term>Human</term>
<term>Nervous system diseases</term>
<term>Paraplegia</term>
<term>Spinal cord trauma</term>
<term>Transplantation</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Paraplégie</term>
<term>Traumatisme de la moelle épinière</term>
<term>Pathologie du système nerveux</term>
<term>Système autologue</term>
<term>Transplantation</term>
<term>Homme</term>
<term>Essai clinique</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">Olfactory ensheathing cells show promise in preclinical animal models as a cell transplantation therapy for repair of the injured spinal cord. This is a report of a clinical trial of autologous transplantation of olfactory ensheathing cells into the spinal cord in six patients with complete, thoracic paraplegia. We previously reported on the methods of surgery and transplantation and the safety aspects of the trial I year after transplantation. Here we address the overall design of the trial and the safety of the procedure, assessed during a period of 3 years following the transplantation surgery. All patients were assessed at entry into the trial and regularly during the period of the trial. Clinical assessments included medical, psychosocial, radiological and neurological, as well as specialized tests of neurological and functional deficits (standard American Spinal Injury Association and Functional Independence Measure assessments). Quantitative test included neurophysiological tests of sensory and motor function below the level of injury. The trial was a Phase 1/lla design whose main aim was to test the feasibility and safety of transplantation of autologous olfactory ensheathing cells into the injured spinal cord in human paraplegia. The design included a control group who did not receive surgery, otherwise closely matched to the transplant recipient group. This group acted as a control for the assessors, who were blind to the treatment status of the patients. The control group also provided the opportunity for preliminary assessment of the efficacy of the transplantation.There were no adverse findings 3 years after autologous transplantation of olfactory ensheathing cells into spinal cords injured at least 2 years prior to transplantation.The magnetic resonance images (MRls) at 3 years showed no change from preoperative MRls or intervening MRls at I and 2 years, with no evidence of any tumour of introduced cells and no development of post-traumatic syringomyelia or other adverse radiological findings.There were no significant functional changes in any patients and no neuropathic pain. In one transplant recipient, there was an improvement over 3 segments in light touch and pin prick sensitivity bilaterally, anteriorly and posteriorly. We conclude that transplantation of autologous olfactory ensheathing cells into the injured spinal cord is feasible and is safe up to 3 years of post-implantation, however, this conclusion should be considered preliminary because of the small number of trial patients.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Australie</li>
<li>France</li>
<li>Suisse</li>
</country>
<region>
<li>Canton de Zurich</li>
<li>Provence-Alpes-Côte d'Azur</li>
</region>
<settlement>
<li>Marseille</li>
<li>Zurich</li>
</settlement>
</list>
<tree>
<country name="Suisse">
<region name="Canton de Zurich">
<name sortKey="Dietz, Volker" sort="Dietz, Volker" uniqKey="Dietz V" first="Volker" last="Dietz">Volker Dietz</name>
</region>
</country>
<country name="Australie">
<noRegion>
<name sortKey="Mackay Sim, A" sort="Mackay Sim, A" uniqKey="Mackay Sim A" first="A." last="Mackay-Sim">A. Mackay-Sim</name>
</noRegion>
<name sortKey="Bassingthwaighte, L" sort="Bassingthwaighte, L" uniqKey="Bassingthwaighte L" first="L." last="Bassingthwaighte">L. Bassingthwaighte</name>
<name sortKey="Bayliss, C" sort="Bayliss, C" uniqKey="Bayliss C" first="C." last="Bayliss">C. Bayliss</name>
<name sortKey="Cochrane, J" sort="Cochrane, J" uniqKey="Cochrane J" first="J." last="Cochrane">J. Cochrane</name>
<name sortKey="Davies, W" sort="Davies, W" uniqKey="Davies W" first="W." last="Davies">W. Davies</name>
<name sortKey="Feron, F" sort="Feron, F" uniqKey="Feron F" first="F." last="Feron">F. Feron</name>
<name sortKey="Fronek, P" sort="Fronek, P" uniqKey="Fronek P" first="P." last="Fronek">P. Fronek</name>
<name sortKey="Geraghty, T" sort="Geraghty, T" uniqKey="Geraghty T" first="T." last="Geraghty">T. Geraghty</name>
<name sortKey="Gray, C" sort="Gray, C" uniqKey="Gray C" first="C." last="Gray">C. Gray</name>
<name sortKey="Kerr, G" sort="Kerr, G" uniqKey="Kerr G" first="G." last="Kerr">G. Kerr</name>
<name sortKey="Licina, P" sort="Licina, P" uniqKey="Licina P" first="P." last="Licina">P. Licina</name>
<name sortKey="Nowitzke, A" sort="Nowitzke, A" uniqKey="Nowitzke A" first="A." last="Nowitzke">A. Nowitzke</name>
<name sortKey="Perry, C" sort="Perry, C" uniqKey="Perry C" first="C." last="Perry">C. Perry</name>
<name sortKey="Silburn, P A S" sort="Silburn, P A S" uniqKey="Silburn P" first="P. A. S." last="Silburn">P. A. S. Silburn</name>
<name sortKey="Urquhart, S" sort="Urquhart, S" uniqKey="Urquhart S" first="S." last="Urquhart">S. Urquhart</name>
</country>
<country name="France">
<region name="Provence-Alpes-Côte d'Azur">
<name sortKey="Feron, F" sort="Feron, F" uniqKey="Feron F" first="F." last="Feron">F. Feron</name>
</region>
</country>
</tree>
</affiliations>
</record>

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