Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04798716
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-03-11
First Post:
2021-03-12
Brief Title:
The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19
Sponsor:
AVEM HealthCare
Organization:
AVEM HealthCare
Study Overview
Official Title:
Mesenchymal Stem Cell Exosomes for the Treatment of COVID-19 Positive Patients With Acute Respiratory Distress Syndrome andor Novel Coronavirus Pneumonia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARDOXSO
Brief Summary:
Novel coronavirus pneumonia NCP and acute respiratory distress syndrome ARDS are both associated with the prevailing upper respiratory tract infections caused by the RNA-containing SARS-CoV2 virus of the genius Betacoronavirus of the Coronaviridae family As both the viral infiltration and infection progress the host immune system response can be one of a rapidly developing fatal cytokine storm In the ARDS or NCP ensuing progression the patient often succumbs to the effects of the hyper pro-inflammatory response hence contributing to the associated increased mortality as a result of the cytokine storm and associated pathogenesis
Detailed Description:
In December of 2019 in Wuhan China a novel coronavirus outbreak began Globally this disease referred to as COVID-19 is the result of a novel SARS-CoV2 virus which predominantly targets Type II lung alveolar cells AT2 The hyper response of the host immune system can rapidly evolve into a life-threatening cytokine-release syndrome or cytokine storm The cytokine storm can predispose the patient to ARDS andor NCP or both Left unchecked the ARDS pathogenesis rapidly culminates in disruption of cell cytotoxicity mechanisms excessive activation of cytotoxic lymphocytes and a predominance of type I M1 macrophage resulting in the massive release of a host of proinflammatory cytokines FNO-α IL-1 IL-2 IL-6 IL-8 IL-10 granulocytic colony-stimulating factor monocytic chemoattractive protein 1 The result systemically is a rise in surrogate inflammatory markers C Reactive Protein serum ferritin with a corresponding infiltration of internal organs and tissues by activated macrophage T-lymphocytes and a predominance of cellular apoptosis The resulting hyperinflammatory pathogenic reaction may result in severe aveolar lesions leading to death scarring or severe lung damage persisting well after discharge
Experimental studies have demonstrated that mesenchymal stem cells MSCs and MSC-culutre media MSC-CM may significantly reduce the pro-inflammatory bias and associated pathologic impairment resulting The MSC-CM known to contain exosomes has been shown to have an anti-inflammatory effect Further exosomes associated with the amniotic membrane long used in the treatment of burn and wounds have been show to have a regenerative effect
The purpose of this protocol is to explore the safety and efficacy of an intravenous injection of MSC derived exosomes in the treatment of severe patients moderate to severe Berlin score with ARDS or NCP
Experimental studies have demonstrated that mesenchymal stem cells MSCs and MSC-culutre media MSC-CM may significantly reduce the pro-inflammatory bias and associated pathologic impairment resulting The MSC-CM known to contain exosomes has been shown to have an anti-inflammatory effect Further exosomes associated with the amniotic membrane long used in the treatment of burn and wounds have been show to have a regenerative effect
The purpose of this protocol is to explore the safety and efficacy of an intravenous injection of MSC derived exosomes in the treatment of severe patients moderate to severe Berlin score with ARDS or NCP
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None