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自体骨髓浓缩物椎间盘内注射治疗退行性椎间盘疾病的三年随访

Autologous bone marrow concentrate intradiscal injection for the treatment of degenerative disc disease with three-year follow-up.

作者信息

Pettine Kenneth A, Suzuki Richard K, Sand Theodore T, Murphy Matthew B

机构信息

Elite Regenerative Stem Cell Specialists, 4795 Larimer Pkwy, Johnstown, CO, 80534, USA.

Celling Biosciences, 93 Red River Street, Austin, TX, 78701, USA.

出版信息

Int Orthop. 2017 Oct;41(10):2097-2103. doi: 10.1007/s00264-017-3560-9. Epub 2017 Jul 26.

Abstract

PURPOSE

The purpose of this study is to assess safety and feasibility of intradiscal bone marrow concentrate (BMC) injections to treat low back discogenic pain as an alternative to surgery with three year minimum follow-up.

METHODS

A total of 26 patients suffering from degenerative disc disease and candidates for spinal fusion or total disc replacement surgery were injected with 2 ml autologous BMC into the nucleus pulposus of treated lumbar discs. A sample aliquot of BMC was characterized by flow cytometry and CFU-F assay to determine progenitor cell content. Improvement in pain and disability scores and 12 month post-injection MRI were compared to patient demographics and BMC cellularity.

RESULTS

After 36 months, only six patients progressed to surgery. The remaining 20 patients reported average ODI and VAS improvements from 56.7 ± 3.6 and 82.1 ± 2.6 at baseline to 17.5 ± 3.2 and 21.9 ± 4.4 after 36 months, respectively. One year MRI indicated 40% of patients improved one modified Pfirrmann grade and no patient worsened radiographically. Cellular analysis showed an average of 121 million total nucleated cells per ml, average CFU-F of 2713 per ml, and average CD34+ of 1.82 million per ml in the BMC. Patients with greater concentrations of CFU-F (>2000 per ml) and CD34+ cells (>2 million per ml) in BMC tended to have significantly better clinical improvement.

CONCLUSIONS

There were no adverse events related to marrow aspiration or injection, and this study provides evidence of safety and feasibility of intradiscal BMC therapy. Patient improvement and satisfaction with this surgical alternative supports further study of the therapy.

摘要

目的

本研究旨在评估椎间盘内注射骨髓浓缩物(BMC)治疗下腰痛性椎间盘源性疼痛作为手术替代方法的安全性和可行性,并进行至少三年的随访。

方法

共有26例患有退行性椎间盘疾病且适合脊柱融合或全椎间盘置换手术的患者,将2毫升自体BMC注射到治疗的腰椎间盘髓核中。通过流式细胞术和集落形成单位-成纤维细胞(CFU-F)测定对BMC的样本等分试样进行表征,以确定祖细胞含量。将疼痛和残疾评分的改善情况以及注射后12个月的MRI与患者人口统计学和BMC细胞数量进行比较。

结果

36个月后,只有6例患者进展为手术。其余20例患者报告,平均腰椎功能障碍指数(ODI)和视觉模拟评分(VAS)从基线时的56.7±3.6和82.1±2.6分别改善至36个月后的17.5±3.2和21.9±4.4。一年后的MRI显示,40%的患者改良Pfirrmann分级改善一级,且影像学上无患者病情恶化。细胞分析显示,BMC中平均每毫升有1.21亿个有核细胞,平均每毫升CFU-F为2713个,平均每毫升CD34+细胞为182万个。BMC中CFU-F浓度较高(>2000个/毫升)和CD34+细胞浓度较高(>200万个/毫升)的患者临床改善往往明显更好。

结论

未发生与骨髓抽吸或注射相关的不良事件,本研究提供了椎间盘内BMC治疗安全性和可行性的证据。患者对这种手术替代方法的改善和满意度支持对该治疗方法进行进一步研究。

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