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Preclinical Studies on Convalescent Human Immune Plasma-Derived Exosome: Omics and Antiviral Properties to SARS-CoV-2.

ABSTRACT: The scale of the COVID-19 pandemic forced urgent measures for the development of new therapeutics. One of these strategies is the use of convalescent plasma (CP) as a conventional source for passive immunity. Recently, there has been interest in CP-derived exosomes. In this report, we present a structural, biochemical, and biological characterization of our proprietary product, convalescent human immune plasma-derived exosome (ChipEXO), following the guidelines set forth by the Turkish Ministry of Health and the Turkish Red Crescent, the Good Manufacturing Practice, the International Society for Extracellular Vesicles, and the Gene Ontology Consortium. The data support the safety and efficacy of this product against SARS-CoV-2 infections in preclinical models.

SUBMITTER: Taslı NP

PROVIDER: S-EPMC8987587 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Preclinical Studies on Convalescent Human Immune Plasma-Derived Exosome: Omics and Antiviral Properties to SARS-CoV-2.

Taşlı Neslihan Pakize NP Gönen Zeynep Burçin ZB Kırbaş Oğuz Kaan OK Gökdemir Nur Seda NS Bozkurt Batuhan Turhan BT Bayrakcı Buse B Sağraç Derya D Taşkan Ezgi E Demir Sevda S Ekimci Gürcan Nur N Bayındır Bilgiç Melike M Bayrak Ömer Faruk ÖF Yetişkin Hazel H Kaplan Büşra B Pavel Shaikh Terkıs Islam STI Dinç Gökçen G Serhatlı Müge M Çakırca Gamze G Eken Ahmet A Aslan Vedat V Yay Mehmet M Karakukcu Musa M Unal Ekrem E Gül Fethi F Basaran Kemal Erdem KE Ozkul Yusuf Y Şahin Fikrettin F Jones Olcay Y OY Tekin Şaban Ş Özdarendeli Aykut A Cetin Mustafa M

Frontiers in immunology 20220324

The scale of the COVID-19 pandemic forced urgent measures for the development of new therapeutics. One of these strategies is the use of convalescent plasma (CP) as a conventional source for passive immunity. Recently, there has been interest in CP-derived exosomes. In this report, we present a structural, biochemical, and biological characterization of our proprietary product, convalescent human immune plasma-derived exosome (ChipEXO), following the guidelines set forth by the Turkish Ministry ...[more]

PMID: 35401544

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Project description:The scale of the COVID-19 pandemic required the emergency development of treatment strategies. One of these strategies is the use of convalescent plasma (CP), isolated from patients recovered from a disease as a therapeutic for new patients. The use of convalescent human immune plasma derived exosomes (ChipEXO) in place of whole plasma can address issues associated with CP therapies while inducing a similar therapeutic response in recipients. Isolated exosomes would be pure of soluble protein contaminants such as coagulation factors, which can cause serious side effects such as blood clots and endothelial damage. In the light of this information, in this study, we examined the use of ChipEXO against the SARS-CoV-2 virus in terms of safety and efficacy, based on the omic analysis of ChipEXO in terms of protein and miRNA. The isolated ChipEXO was characterized according to the criteria determined by the MISEV commission. To elucidate the molecular mechanism of the exosome's activity, proteomic and miRNA analyzes were made and its content was clarified. After performing the ontological and orthological analyzes, the safety of ChipEXO for tissue and organism has been studied on both in vitro cell culture and in vivo animals. ChipEXO, which did not cause any toxic effects, was this time examined for its efficacy to examine the possible effects it may develop against SARS-CoV-2. With the guidance of the results obtained as a result of the studies, it has been revealed that ChipEXO has an effect that provides both anti-viral and tissue protection against the virus. In addition to these data, we encounter a picture in which the cytokine storm is suppressed and the complement system is modulated, and tissue homeostasis is provided in the detail of the molecular mechanism in which its anti-viral activity is discussed. With detailed pre-clinical and clinical studies to be done, ChipEXO is a promising drug candidate with high efficacy against SARS-CoV-2 therapy.

Project description:BackgroundThere is some evidence showing rebound of COVID-19 infections in patients treated with nirmatrelvir-ritonavir between 2 and 8 days following cessation of the antiviral treatment. COVID-19 rebound is not unique to patients treated with nirmatrelvir-ritonavir, but is also observed in molnupiravir recipients, in patients who did not receive any antiviral treatment and in patients who received convalescent plasma (CP).Materials and methodsThis was a systematic review with meta-analysis of clinical trials evaluating rates of virologic and clinical rebound in COVID-19 patients receiving antiviral agents, CP or no treatment. Both randomized clinical trials and controlled cohort studies were considered. The methodological quality of trials was assessed using ROB-2 and ROBIN-1 checklists, and the GRADE approach.ResultsData were available from 16 trials. The occurrence of virologic rebound was more commonly observed among nirmatrelvir recipients than among untreated patients (relative risk [RR]=2.12; 95% confidence interval [CI]: 1.38-3.28; p=0.0007). No differences were observed in the occurrence of virologic rebound between nirmatrelvir-ritonavir and molnupiravir recipients (RR=1.01; 95% CI: 0.71-1.43). Similar rates of virologic rebounds were observed in molnupiravir recipients and untreated patients (RR=1.14; 95% CI: 0.81-1.6). One study in the pre-omicron period compared rates of virologic rebound between patients receiving standard of care with or without CP: no differences were observed between groups (RR=1.04; 95% CI: 0.55-1.99). Rates of clinical rebound were reported in seven trials, five evaluating nirmatrelvir-ritonavir and untreated patients, and two evaluating nirmatrelvir-ritonavir and molnupiravir recipients. No statistically significant differences between groups were observed. For all these comparisons, the certainty of the available evidence was graded as low or moderate.DiscussionVirologic rebound of COVID-19 infections appears to be mild and self-limited, and was observed more commonly in nirmatrelvir-ritonavir recipients than in untreated patients, but was also observed in patients treated with molnupiravir or CP.

Dataset Information

Preclinical Studies on Convalescent Human Immune Plasma-Derived Exosome: Omics and Antiviral Properties to SARS-CoV-2.

Publications

Preclinical Studies on Convalescent Human Immune Plasma-Derived Exosome: Omics and Antiviral Properties to SARS-CoV-2.

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