背景:在临床前研究中,使用双同种异体移植物在促进组织血运重建方面显示出有希望的结果,减少梗死面积,防止不良重塑和纤维化,最终增强心脏功能。在这些发现的基础上,PeriCord的安全性,由去细胞化的心包基质和脐带沃顿胶质间充质基质细胞组成的工程化组织移植物,在PERISCOPEI期临床试验(NCT03798353)中进行了评估,标志着它在人类受试者中的首次应用。
方法:这是双盲,纳入符合手术血运重建条件的非急性心肌梗死患者的单中心试验.7名患者植入PeriCord,5名患者作为对照。
结果:接受PeriCord的患者在术后阶段和一年的随访中没有出现不良反应。次要结果没有显著变化,如生活质量或心功能,在接受PeriCord的患者中发现。然而,PeriCord确实调节了参与梗死后心肌修复的循环单核细胞向非经典炎症解决巨噬细胞的动力学,以及治疗后血浆中单核细胞化学引诱物和预后标志物Meteorin样的水平。
结论:总之,PeriCord移植物表现出安全的特征和显着的免疫调节特性。然而,需要进一步的研究才能充分发挥其作为治疗炎症相关病理平台的潜力.
背景:这项工作部分得到了MICINN(SAF2017-84324-C2-1-R)的资助;SaludCarlosIII研究所(ICI19/00039和RedRICORS-TERAVRD21/0017/0022,和CIBER心血管CB16/11/00403)的一部分并由ISCIII-SubdirecciónGeneraldeEvaluación和FondoEuropeodeDesarrolloRegional(FEDER)和AGAUR(2021-SGR-01437)共同资助。
BACKGROUND: In preclinical studies, the use of double allogeneic grafts has shown promising results in promoting tissue revascularization, reducing infarct size, preventing adverse remodelling and fibrosis, and ultimately enhancing cardiac function. Building upon these findings, the safety of PeriCord, an engineered tissue graft consisting of a decellularised pericardial matrix and umbilical cord Wharton\'s jelly mesenchymal stromal cells, was evaluated in the PERISCOPE Phase I clinical
trial (NCT03798353), marking its first application in human subjects.
METHODS: This was a double-blind, single-centre
trial that enrolled patients with non-acute myocardial infarction eligible for surgical revascularization. Seven patients were implanted with PeriCord while five served as controls.
RESULTS: Patients who received PeriCord showed no adverse effects during post-operative phase and one-year follow-up. No significant changes in secondary outcomes, such as quality of life or cardiac function, were found in patients who received PeriCord. However, PeriCord did modulate the kinetics of circulating monocytes involved in post-infarction myocardial repair towards non-classical inflammation-resolving macrophages, as well as levels of monocyte chemoattractants and the prognostic marker Meteorin-like in plasma following treatment.
CONCLUSIONS: In summary, the PeriCord graft has exhibited a safe profile and notable immunomodulatory properties. Nevertheless, further research is required to fully unlock its potential as a platform for managing inflammatory-related pathologies.
BACKGROUND: This work was supported in part by grants from MICINN (SAF2017-84324-C2-1-R); Instituto de Salud Carlos III (ICI19/00039 and Red RICORS-TERAV RD21/0017/0022, and CIBER Cardiovascular CB16/11/00403) as a part of the Plan Nacional de I + D + I, and co-funded by ISCIII-Subdirección General de Evaluación y el Fondo Europeo de Desarrollo Regional (FEDER) and AGAUR (2021-SGR-01437).