An acellular biologic scaffold treatment for volumetric muscle loss: results of a 13-patient cohort study

An acellular biologic scaffold treatment for volumetric muscle loss: results of a 13-patient cohort study
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DOI:
10.1038/npjregenmed.2016.8
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发表时间:
2016-07-21
影响因子:
7.2
通讯作者:
Rubin, J. Peter
Rubin, J. Peter
中科院分区:
医学1区
文献类型:
--
作者:
Dziki, Jenna;Badylak, Stephen;Rubin, J. Peter

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肌肉体积损失(VML)是一个严重的和衰弱的临床问题。目前的护理标准包括物理治疗或矫形术,其不能纠正潜在的力量缺陷,以及手术肌腱转移或肌肉转移,其涉及供体部位发病率并且不能恢复功能。本文描述了13名患者队列研究的结果,并且涉及用于VML治疗的再生医学方法。植入由哺乳动物细胞外基质(ECM)组成的脱细胞生物支架,并在治疗后结合积极的早期物理治疗。进行超声引导活检的免疫标记、磁共振成像和计算机断层扫描成像,以分析干/祖细胞的存在和新骨骼肌的形成。物理治疗师分析了力的产生,运动范围和功能任务的表现。电诊断评估用于分析受神经支配的骨骼肌的存在。本研究注册于ClinicalTrials.gov,编号NCT 01292876。ECM生物支架的体内重塑与血管周围干细胞的动员有关;在植入部位内形成新的、血管化的、神经支配的骨骼肌岛;与术前表现相比,增加了力的产生;并改善了功能任务表现。与术前相比,ECM植入后6个月,患者表现出平均37.3%的改善(P
Volumetric muscle loss (VML) is a severe and debilitating clinical problem. Current standard of care includes physical therapy or orthotics, which do not correct underlying strength deficits, and surgical tendon transfers or muscle transfers, which involve donor site morbidity and fall short of restoring function. The results of a 13-patient cohort study are described herein and involve a regenerative medicine approach for VML treatment. Acellular bioscaffolds composed of mammalian extracellular matrix (ECM) were implanted and combined with aggressive and early physical therapy following treatment. Immunolabeling of ultrasound-guided biopsies, and magnetic resonance imaging and computed tomography imaging were performed to analyse the presence of stem/progenitor cells and formation of new skeletal muscle. Force production, range-of-motion and functional task performance were analysed by physical therapists. Electrodiagnostic evaluation was used to analyse presence of innervated skeletal muscle. This study is registered with ClinicalTrials.gov, numbers NCT01292876. In vivo remodelling of ECM bioscaffolds was associated with mobilisation of perivascular stem cells; formation of new, vascularised, innervated islands of skeletal muscle within the implantation site; increased force production; and improved functional task performance when compared with pre-operative performance. Compared with pre-operative performance, by 6 months after ECM implantation, patients showed an average improvement of 37.3% (P