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Clinical experience in cell-based therapeutics: intervention and outcome

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Abstract

Disc herniation treated by discectomy results in a significant loss of nucleus material and disc height. Biological restoration through the use of autologous disc chondrocyte transplantation (ADCT) offers a potential to achieve functional integration of disc metabolism and mechanics. Nucleus regeneration using autologous cultured disc-derived chondrocytes has been demonstrated in a canine model and in clinical pilot studies. In 2002 a prospective, controlled, randomized, multicentre study comparing safety and efficacy of ADCT plus discectomy, with discectomy alone was initiated. The clinical goals were to provide long-term pain relief, maintain disc height, and prevent adjacent segment disease. Interim analysis was performed after 2 years; Oswestry (Low Back Pain/disability), Quebec Back Pain Disability Scale, as well as Prolo and VAS Score were used for the evaluation. Disc height was assessed by MRI. A clinically significant reduction of low back pain in the ADCT-treated group was shown by all three pain score systems. The median total Oswestry Score was 2 in the ADCT group compared with 6 in the control group. Decreases in the Disability index in ADCT-treated patients correlated with the reduction of low back pain. Decreases in disc height over time were only found in the control group, and of potential significance, intervertebral discs in adjacent segments appeared to retain hydration when compared to those adjacent to levels that had undergone discectomy without cell intervention.

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Acknowledgments

Financial and clinical support for this study was underwritten by co.don AG, Teltow, Germany. Additional collaboration was supported by Bergmannstrost, the Atlanta Medical Center, and the Emory Spine Center.

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Authors and Affiliations

  1. Bergmannstrost, Neurochirurgie klinik, Merseburger Strasse 165, 06112, Halle, Saale, Germany

    Hans Joerg Meisel & Yvonne Minkus

  2. Atlanta Medical Center, 303 Parkway Drive NE, BOX 227, Atlanta, GA, 30312, USA

    Timothy Ganey

  3. Emory Spine Center, 59 Executive Park South, Atlanta, GA, 30329, USA

    William C. Hutton

  4. co.don AG, Warthestraße 21, 14513, Teltow, Germany

    Jeanette Libera & Olivera Alasevic

Authors
  1. Hans Joerg Meisel
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  2. Timothy Ganey
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  3. William C. Hutton
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  4. Jeanette Libera
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  5. Yvonne Minkus
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  6. Olivera Alasevic
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Corresponding author

Correspondence to Timothy Ganey.

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Meisel, H.J., Ganey, T., Hutton, W.C. et al. Clinical experience in cell-based therapeutics: intervention and outcome. Eur Spine J 15 (Suppl 3), 397–405 (2006). https://doi.org/10.1007/s00586-006-0169-x

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  • DOI: https://doi.org/10.1007/s00586-006-0169-x

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