Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753476
Status:
UNKNOWN
Last Update Posted:
2021-05-24
First Post:
2021-02-11
Brief Title:
Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia
Sponsor:
Stem Cell and Cancer Research Indonesia
Organization:
Stem Cell and Cancer Research Indonesia
Study Overview
Official Title:
The Effect of Secretome of Hypoxia-Mesenchymal Stem Cells in Improving Survival of Severe Covid-19 Patients
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
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:
None
Brief Summary:
In this randomized controlled trial RCT severe cases of COVID-19 infection will be treated with secretome of hypoxia-mesenchymal stem cells The improvement in clinical laboratory and radiological manifestations will be evaluated in treated patients compared with the control group
Detailed Description:
The devastating effect of severe acute respiratory syndrome coronavirus-2 SARS COV-2 infection is caused by a robust cytokine storm that leads to lung tissue damage Several studies reported a correlation between disease severity and the release of excessive proinflammatory cytokines such as tumor necrosis factor-α TNF-α IL-6 IL-1 IFN-Υ IFN-Υ-induced protein 10 IP10 monocyte chemoattractant protein-1 MCP-1 macrophage inflammatory protein-1a MIP-1a and granulocyte-colony stimulating factor G-CSF This finding was confirmed by the high level of plasma cytokines found in most severe COVID-19 patients associated with extensive lung damage Therefore finding an effective therapeutic option to control the devastating cytokine storm of COVID-19 and regenerate the damaged lung is crucial
Previous studies reported that the hypoxic condition of MSCs could enhance the release of their active soluble molecules known as Secretome-MSCs S-MSCs such as IL-10 and TGF-β that useful in alleviating inflammation Moreover they could also increase the expression of growth factors such as VEGF and PDGF that accelerate lung injury improvement These active molecules could potentially serve as a biological therapeutic agent for treating the severe SARS-CoV-2 infection According to recent studies we successfully isolated the S-MSCs from their culture medium using tangential flow filtration TFF strategy with several molecular weight cut-off category This study investigated the clinical outcomes of severe COVID-19 patients with several comorbidities treated with S-MSCs in Indonesia
Previous studies reported that the hypoxic condition of MSCs could enhance the release of their active soluble molecules known as Secretome-MSCs S-MSCs such as IL-10 and TGF-β that useful in alleviating inflammation Moreover they could also increase the expression of growth factors such as VEGF and PDGF that accelerate lung injury improvement These active molecules could potentially serve as a biological therapeutic agent for treating the severe SARS-CoV-2 infection According to recent studies we successfully isolated the S-MSCs from their culture medium using tangential flow filtration TFF strategy with several molecular weight cut-off category This study investigated the clinical outcomes of severe COVID-19 patients with several comorbidities treated with S-MSCs in Indonesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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