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首页> 外文期刊>European Cells & Materials >Intervertebral disc repair with activated nucleus pulposus cell transplantation: a three-year, prospective clinical study of its safety
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Intervertebral disc repair with activated nucleus pulposus cell transplantation: a three-year, prospective clinical study of its safety

机译：活化髓核细胞移植修复椎间盘：三年安全性前瞻性临床研究

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Degeneration of the lumbar intervertebral discs is irreversible, with no treatment currently available. Building upon experimental studies that demonstrated the importance of the nucleus pulposus (NP) in preserving disc structure, we demonstrated that reinsertion of NP cells slowed further disc degeneration and that direct cell-to-cell contact co-culture with mesenchymal stromal cells (MSCs) significantly upregulated the viability of NP cells in basic and pre-clinical studies in vitro and in vivo using animal models and human cells. Here, we report a 3-year result of a prospective clinical study, aimed to assess the safety and efficacy of activated NP cell transplantation in the degenerate lumbar intervertebral disc. Candidates were 9 patients aged 20-29 years who had Pfirrmann’s grade III disc degeneration at the level adjacent to the level scheduled for posterior lumbar intervertebral fusion. Viable NP cells from the fused disc were co-cultured in direct contact with autologous bone marrow-derived MSCs. One million activated NP cells were transplanted into the degenerated disc adjacent to the fused level at 7 d after the first fusion surgery. No adverse effects were observed during the 3-year follow-up period. Magnetic resonance imaging did not show any detrimental effects to the transplanted discs and revealed a mild improvement in 1 case. No cases reported any low back pain. Our clinical study confirmed the safety of activated NP cell transplantation, and the findings suggest the minimal efficacy of this treatment to slow the further degeneration of human intervertebral discs.
机译：腰椎间盘退变是不可逆的，目前尚无治疗方法。基于表明髓核（NP）在保留椎间盘结构中的重要性的实验研究的基础上，我们证明了NP细胞的重新插入减缓了椎间盘的进一步变性，并且直接与间质基质细胞（MSC）进行细胞间接触共培养在使用动物模型和人类细胞进行的体外和体内基础和临床前研究中，NP细胞的活力显着上调。在这里，我们报告了一项为期3年的前瞻性临床研究结果，旨在评估退化性腰椎间盘中激活NP细胞移植的安全性和有效性。候选者为9名20-29岁的患者，他们的PfirrmannⅢ级椎间盘退变程度与腰椎后路椎间融合术预定的水平相近。将来自融合盘的活的NP细胞与自体骨髓来源的MSC直接接触进行共培养。第一次融合手术后第7天，将一百万个激活的NP细胞移植到与融合水平相邻的变性椎间盘中。在三年的随访期内未观察到不良反应。磁共振成像未显示出对移植椎间盘的任何有害影响，显示1例有轻度改善。没有病例报告腰痛。我们的临床研究证实了激活的NP细胞移植的安全性，并且发现表明这种治疗减缓人类椎间盘进一步变性的最小功效。

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