Author: Stewart, Danique ; Kelly, Kaitlyn ; Shapiro, George C ; Khan, Aisha ; Abdullah, Zanub ; Young, Karen C ; Bellio, Michael A ; Williams, Kevin ; Milberg, Julian ; Huang, Jian ; Santos, Ivan ; Chen, Pingping ; Arango, Alissa ; Sterling, Shanique ; Mitrani, Maria Ines ; Xu, Xiumin

BACKGROUND AIMSExtracellular vesicles (EVs) are being tested for their use as novel therapeutics. However, the optimal source of EVs is currently under investigation. Amniotic fluid (AF) is a natural source of EVs that can be easily obtained for use in regenerative medicine, yet AF-EV characterization has not been fully explored.METHODSHere the authors demonstrate AF as a rich source of EVs and identify the microRNA and proteomic cargo. Bioinformatics analysis of this cargo revealed multiple pathway targets, including immunomodulatory, anti-inflammatory and free radical scavenging networks. The authors further demonstrated the therapeutic potential of this EV product as a novel preventative agent for bronchopulmonary dysplasia (BPD).RESULTSIntra-tracheal administration of AF-EVs preserved alveolar development, attenuated vascular remodeling and pulmonary hypertension, decreased lung pro-inflammatory cytokine expression and reduced macrophage infiltration in an experimental BPD model.CONCLUSIONSThe authors' results suggest that AF is a viable biological fluid for EV harvest and that AF-EVs have strong therapeutic potential for pulmonary diseases, such as BPD, warranting further development to transition this novel EV product into the clinic.

01 Jan 2021·Respiratory Medicine Case Reports

Treatment of a COVID-19 long hauler with an amniotic fluid-derived extracellular vesicle biologic

Author: Xu, Xiumin ; Khan, Aisha ; Arango, Alissa ; Shapiro, George C ; Bellio, Michael A ; Mitrani, Maria Ines ; Meglin, Allen ; Haskell, Gwendolyn

Post-COVID-19 infection symptoms such as mental fog, tachycardia, and extreme fatigue are just a few of the symptoms wreaking havoc on patients' lives. Patients with long-term symptoms following COVID-19 are being called long haulers. To date, long haulers are receiving little to no guidance from physicians on their lingering COVID-19 symptoms with limited treatment options available. Zofin is an acellular biologic that contains the extracellular vesicle (EV) fraction of human amniotic fluid and is under investigation for use as a COVID-19 therapeutic. We obtained FDA and IRB approval to investigate the therapeutic use of Zofin in a single long hauler patient case experiencing prolonged shortness of breath and respiratory impairment. Administration of the EV product was shown to be safe. Furthermore, demonstrated respiratory improvements through chest X ray images and oxygen saturation measurement. The single patient IND studies were completed without any reported adverse events or safety concerns. Furthermore, these completed studies demonstrate the feasibility and a therapeutic potential of amniotic fluid-derived EVs for COVID-19 long hauler intervention.

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