Am J Sports Med:自体脂肪干细胞治疗膝关节炎安全、有效

2018-01-06 佚名 “Cell”微信号

近期,韩国首尔大学几位学者的一篇文章填补了自体脂肪组织来源的间充质干细胞通过关节腔注射治疗膝关节炎安全有效性评估在中期研究上的空白。

近期,韩国首尔大学几位学者的一篇文章填补了自体脂肪组织来源的间充质干细胞通过关节腔注射治疗膝关节炎安全有效性评估在中期研究上的空白。

骨关节炎是老年人致残的首要原因。

在55 - 60岁阶段,骨关节炎的发病率急剧上升。60岁以上达60%,75岁以上超过80%。

更残酷的是,骨关节炎是一种退行性疾病,目前没有根治的可能。

近几年,细胞治疗成为骨关节炎研究的热点。针对骨关节炎及类似疾病,国外已经上市了两款细胞药物。

一款是比利时2009年批准上市的ChondroCelect,来源于自体软骨的细胞治疗制品。

而2012年韩国批准的退行性关节炎干细胞制剂Cartistem的主要成分是脐带血间充质干细胞。

与此同时,国内外也有了大量通过关节腔注射间充质干细胞来治疗骨关节炎的临床研究,但普遍研究周期较短,主要是3 - 6个月。

2017年10月,《美国运动医学杂志》刊发了Chris Hyunchul Jo 等韩国学者的一篇文章。

Chris Hyunchul Jo 等人对他们此前一项临床试验的受试者进行了为期2年的随访调查。

结果表明,在2年时间内,关节腔注射自体脂肪组织来源的间充质干细胞治疗膝关节炎安全、有效。

这项研究是一项 I/II期临床试验(NCT01300598)的随访研究。临床试验开始于2009年3月,结束于2011年9月。

18位受试者(年龄跨度52 - 72岁,平均年龄61.8岁)被平均分配到 I期和 II期临床试验。按注射的细胞量又可分为低剂量组、中剂量组、高剂量组(1.0 x 10^7, 5.0 x 10^7, 1.0 x 10^8)。

主要结果

关节腔注射自体脂肪组织来源的间充质干细胞治疗膝关节炎,未见严重不良反应(包括但不限于肿瘤、异常软骨及骨组织生长)。

无论是低剂量组、中剂量组或高剂量组,间充质干细胞注射都能在2年内改善膝关节功能,减轻膝关节疼痛。

中低剂量组的临床改善在1年后趋于退化,只有高剂量组在2年内的临床改善有统计学意义。高剂量组的WOMAC评分显着降低。相比初始值,6个月下降39.4%,1年时下降70%,2年时仍降低64.9%。而中低剂量组的改善没有统计学意义。

受试者的MRI评估结果也表现出与临床症状同样的趋势。

以上研究结果表明,临床结果与注射的脂肪间充质干细胞数量密切相关。尽管机制尚不清楚,研究者认为这些细胞对关节软骨的直接再生作用可能大于其旁分泌效应。

这项研究的另一个重要发现是关节腔注射脂肪间充质干细胞后,关节软骨持续再生的临床及结构证据。而此前缺乏反应相关治疗效果持续性的研究结果。

为了更稳定的评估,避免错误,随访研究使用了与初始研究一致的评估工具。

当然,现在作者也认为初始试验设计存在一些不足:

样本量小;未设计对照组;未探讨治疗机制;中剂量组在1年时未随访;缺失1年时MRI数据;还可以增加更多的评估手段;未考虑关节镜探查清理术的积极影响;未研究

注射治疗后的最佳非承重期

脂肪间充质干细胞治疗膝关节炎的安全性和有效性已有大量的文献支持。这篇文献的意义则在于提供了更长观察周期的安全有效性证据。

同时,我们也期待有更多、设计更完善、更长观察期的临床研究来进一步论证关节腔注射脂肪间充质干细胞治疗膝关节炎的安全性和有效性。

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    2018-01-09 xiongjie743

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    2018-01-08 lmm397
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    2018-01-06 虈亣靌

    学习了谢谢作者分享!

    0

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