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Novel Approach to Stem Cell Therapy in Parkinson's Disease

机译：帕金森病中干细胞治疗的新方法

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In this commentary we discuss International Stem Cell Corporation's (ISCO's) approach to developing a pluripotent stem cell based treatment for Parkinson's disease (PD). In 2016, ISCO received approval to conduct the world's first clinical study of a pluripotent stem cell based therapy for PD. The Australian regulatory agency Therapeutic Goods Administration (TGA) and the Melbourne Health's Human Research Ethics Committee (HREC) independently reviewed ISCO's extensive preclinical data and granted approval for the evaluation of a novel human parthenogenetic derived neural stem cell (NSC) line, ISC-hpNSC, in a PD phase 1 clinical trial (ClinicalTrials.gov NCT02452723). This is a single-center, open label, dose escalating 12-month study with a 5-year follow-up evaluating a number of objective and patient-reported safety and efficacy measures. A total of 6 years of safety and efficacy data will be collected from each patient. Twelve participants are recruited in this study with four participants per single dose cohort of 30, 50, and 70 million ISC-hpNSC. The grafts are placed bilaterally in the caudate nucleus, putamen, and substantia nigra by magnetic resonance imaging-guided stereotactic surgery. Participants are 30-70 years old with idiopathic PD 13 years duration and unified PD rating scale motor score (Part III) in the OFF state 49. This trial is fully funded by ISCO with no economic involvement from the patients. It is worth noting that ISCO underwent an exhaustive review process and successfully answered the very comprehensive, detailed, and specific questions posed by the TGA and HREC. The regulatory/ethic review process is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines or novel therapies.
机译：在此评论中，我们讨论国际干细胞公司（ISCO）的方法，以开发帕金森病（PD）的多能干细胞的治疗方法。 2016年，ISCO获得了批准，以进行全球对PD的多能干细胞疗法的第一个临床研究。澳大利亚监管机构治疗机构管理局（TGA）和墨尔本卫生人力研究伦理委员会（HREC）独立地审查了ISCO的广泛的临床前数据，并批准了对新型人育母病衍生神经干细胞（NSC）线ISC-HPNSC的评估批准，在PD第1阶段临床试验中（ClinicalTrials.gov NCT02452723）。这是一个单中心，开放标签，剂量升级为期12个月的研究，随着5年的跟进评估了一些客观和患者报告的安全性和有效措施。每位患者将收集总共6年的安全性和疗效数据。在本研究中招募了十二名参与者，每次单剂量队列30,50和7000万ISC-HPNSC的四个参与者。通过磁共振成像引导的立体定向手术，移植物在尾状核，腐核，腐烂和体积内放置在尾状核，腐烂和体内。参与者是30-70岁，具有特发性PD 13年的持续时间和统一的PD评级秤电机分数（第二部分）在off状态49.本试验由ISCO完全资助，没有患者的经济参与。值得注意的是，ISCO经历了详尽的审查过程，并成功地回答了TGA和HREC构成的非常全面，详细和具体问题。监管/伦理审查过程基于将科学和临床专业知识应用于决策，以确保消费者的益处超过了使用药物或新疗法的任何风险。

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