Assessment of efficacy and safety of sequestrectomy plus autologous disc chondrocytes

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EuroDISC study – assessment of efficacy and safety of sequestrectomy plus autologous disc chondrocytes – second interims analysis

EuroDisc-Studie – Bewertung der Effizienz und Sicherheit der Sequestrektomie in Anwendung mit autologen Knorpelzellen – zweite Zwischenauswertung
H.J. Meisel - Neurochirurgie Klinik Bergmannstrost, Halle
R. Bertagnoli - St. Elisabeth Klinikum, Straubing
M. Mayer - Orthopädische Klinik München-Harlaching
A. Reinhardt - Oberlinhaus Potsdam-Babelsberg
F. Weber - Klinikum Saarbrücken
J. Herdmann - Spine Unit, Neurochirurgische Klinik, Heinrich-Heine Universität Düsseldorf
J. Libera - co.don AG, Teltow
O. Josimovic-Alasevic - co.don AG, Teltow

Deutsche Gesellschaft für Neurochirurgie. 58. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie e.V. (DGNC). Leipzig, 26.-29.04.2007. Düsseldorf: German Medical Science GMS Publishing House; 2007. Doc P 120

(The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dgnc2007/07dgnc375.shtml)

Published: 11-04-2007

© 2007 Meisel et al; licensee . This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.
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Meisel HJ
Bertagnoli R
Mayer M
Reinhardt A
Weber F
Herdmann J
Libera J
Josimovic-Alasevic O

Objective: The development of chronic back pain following lumbar disc herniation, especially after operative procedures, can not be avoided. However, so far no clinical procedure is available to slow down the progression of disc degeneration or to biologically replace the lost tissue. To assess the clinical relevance of the autologous disc-derived chondrocyte transplantation (ADCT) for the regeneration of degenerated intervertebral discs by comparing sequestrectomy only with sequestrectomy followed by autologous disc chondrocyte transplantation using chondrotransplant®DISC (co.don AG, Germany) a multicenter, prospective, randomized, assessment-blinded, controlled clinical trial, the EuroDISC study, was initiated.

Methods: Patients 18 to 60 years of age requiring surgical intervention at one level between L3 and S1 were included; 53 patients, 27 patients within the ADCT-treated group and 26 patients within the control group were assessed within the here presented subgroup analysis. The Oswestry Low Back Pain Disability Questionnaire (OPDQ)(according to Hudson-Cook) after one year was chosen as the primary parameter; the Quebec Back Pain Disability Scale (QBPD), Prolo scale, a VAS, MRI, x-rays and AE/SAE were used as secondary criteria. All patients were treated with a sequestrectomy. From patients included within the ADCT-treated group, the sequestrated disc tissue was used for disc chondrocyte isolation and their autologous propagation. 3 months later the disc-derived chondrocyte transplants were transplanted back into the operated discs nucleus region under fluoroscopic control and following integrity measurement of the anulus fibrosus.

Results: During the follow-up of 2 years, significant differences for the primary parameter OBPD as well as for the secondary parameter QBPD and VAS were found for the autologous disc-derived chondrocyte transplantation. For the ADCT-treated group, the total sumscore of the OPDQ decreased to 2 compared to the control group that only reached 6.5. The disability index of the OPDQ of the ADCT-treated group decreased to 4 compared to 13 for the group of patients that did not receive the autologous disc-derived chondrocyte transplants. The VAS decreased to 9 after ADCT treatment compared to a scaling of 15 for the control group patients that were only operated by sequestrectomy.

Conclusions: The interims results of the EuroDISC study give strong evidence for the safety and efficiency of the disc-derived chondrocyte transplantation applied following sequestrectomy to delay or inhibit ongoing processes of disc degeneration.