Mitrani Maria Ines, Bellio Michael A, Sagel Anthony, Saylor Marie, Kapp William, VanOsdol Kathryn, Haskell Gwendolyn, Stewart Danique, Abdullah Zanub, Santos Ivan, Milberg Julian, Arango Alissa, Mitrani Albert, Shapiro George C
Organicell Regenerative Medicine, Inc., Miami, FL, United States.
Landmark Hospital Athens, Athens, GA, United States.
Front Med (Lausanne). 2021 Mar 17;8:583842. doi: 10.3389/fmed.2021.583842. eCollection 2021.
A human coronavirus (HCoV-19) has caused the novel coronavirus disease (COVID-19) outbreak worldwide. There is an urgent need to develop new interventions to suppress the excessive immune response, protect alveolar function, and repair lung and systemic organ damage. Zofin (previously known as Organicell Flow) is a novel therapeutic that is derived from the soluble and nanoparticle fraction (extracellular vesicles and exosomes) of human amniotic fluid. Here within, we present the clinical outcomes after Zofin treatment in three critically ill patients suffering from severe, multi-organ complications induced by COVID-19 infection. All patients were diagnosed with COVID-19, developed respiratory failure, and were hospitalized for more than 40 days. Zofin was administered to patients concurrently with ongoing medical care who were monitored for 28-days post-therapy. SOFA score assessment, chest X-rays, and inflammatory biomarker testing was performed. There were no adverse events associated with the therapy. The patients showed improvements in ICU clinical status and experienced respiratory improvements. Acute delirium experienced by patients completely resolved and inflammatory biomarkers improved. Primary outcomes demonstrate the therapy was safe, accessible, and feasible. This is the first demonstration of human amniotic fluid-derived nanoparticles as a safe and potentially efficacious therapeutic treatment for respiratory failure induced by COVID-19 infection.
一种人类冠状病毒（HCoV-19）已在全球引发新型冠状病毒病（COVID-19）疫情。迫切需要开发新的干预措施来抑制过度的免疫反应、保护肺泡功能以及修复肺部和全身器官损伤。佐芬（以前称为有机细胞流）是一种新型疗法，源自人羊水的可溶性和纳米颗粒部分（细胞外囊泡和外泌体）。在此，我们展示了佐芬治疗三名因COVID-19感染导致严重多器官并发症的重症患者后的临床结果。所有患者均被诊断为COVID-19，出现呼吸衰竭，住院时间超过40天。在持续医疗护理的同时，对患者使用佐芬进行治疗，并在治疗后对其进行28天的监测。进行了序贯器官衰竭评估（SOFA）评分、胸部X光检查和炎症生物标志物检测。治疗未出现不良事件。患者的重症监护病房临床状况有所改善，呼吸状况也得到改善。患者经历的急性谵妄完全消退，炎症生物标志物有所改善。主要结果表明该疗法安全、可及且可行。这是首次证明源自人羊水的纳米颗粒可作为治疗COVID-19感染所致呼吸衰竭的一种安全且可能有效的疗法。
