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Cell Therapy in Stroke—Cautious Steps Towards a Clinical Treatment

机译:细胞疗法中脑卒中的临床治疗谨慎措施

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In the future, stroke patients may receive stem cell therapy as this has the potential to restore lost functions. However, the development of clinically deliverable therapy has been slower and more challenging than expected. Despite recommendations by STAIR and STEPS consortiums, there remain flaws in experimental studies such as lack of animals with comorbidities, inconsistent approaches to experimental design, and concurrent rehabilitation that might lead to a bias towards positive results. Clinical studies have typically been small, lacking control groups as well as often without clear biological hypotheses to guide patient selection. Furthermore, they have used a wide range of cell types, doses, and delivery methods, and outcome measures. Although some ongoing and recent trial programs offer hints that these obstacles are now being tackled, the Horizon2020 funded RESSTORE trial will be given as an example of inconsistent regulatory requirements and challenges in harmonized cell production, logistic, and clinical criteria in an international multicenter study. The PISCES trials highlight the complex issues around intracerebral cell transplantation. Therefore, a better understanding of translational challenges is expected to pave the way to more successful help for stroke patients.
机译:在未来,中风患者可能会接受干细胞疗法,因为这有可能恢复丢失的功能。然而,临床可交付治疗的发展比预期更慢,更具有挑战性。尽管楼梯和步骤联盟建议,但实验研究中缺乏缺陷,如具有合并症的动物,实验设计的不一致方法,并同时恢复可能导致积极成果的偏见。临床研究通常很小,缺乏对照组以及通常没有明确的生物假设,以引导患者选择。此外,它们使用了各种细胞类型,剂量和递送方法和结果措施。虽然有些持续和最近的审判计划提供了这些障碍现在正在解决的暗示,但地平线2020资助的Resstore审判将作为统一的监管要求,物流和国际多中心研究中的临床标准中的不一致监管要求和挑战的例子。双鱼座试验突出了脑细胞移植周围的复杂问题。因此,预计对翻译挑战的更好理解将为中风患者提供更成功的帮助。

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