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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Injection of Hypoxic Secretome-MSCs intramuscular (deltoideus) : Day 1: 1 cc every 12 hours Day 2: 1 cc every 12 hours Day 3: 1 cc every 12 hours
Patients will be given Standard treatment of Covid-19 which accordance with National protocol
RSUD Bantul
Bantul, Central Java, Indonesia
RECRUITINGRS PKU Muhammadiyah Gamping
Yogyakarta, Central Java, Indonesia
RECRUITINGRS Primaya Bekasi Timur
Bekasi, Jakarta Special Capital Region, Indonesia
Change in patients clinical manifestation
mild, moderate, or severe
Time frame: 1 months
Need for a ventilator
There are respiratory variables that made severe Covid-19 patients previously stable but worsened, requiring a ventilator Divided into two categories: 1. It is necessary 2. No need
Time frame: 1 months
Duration of using a ventilator
Duration of use of a ventilator from the day of intubation to the day of extubation
Time frame: 1 months
Length of stay
The length of stay from the first treatment to the patient's final outcome, recovery, or death
Time frame: 1 months
Routine blood profile
Obtained from patients before and after treatment
Time frame: 2 weeks
CRP
Obtained from patients before and after treatment
Time frame: 2 weeks
D-dimer
Obtained from patients before and after treatment
Time frame: 2 weeks
Blood Gas Analisis (BGA)
Obtained from patients before and after treatment
Time frame: 2 weeks
Photo thorax
Obtained from patients before and after treatment
Time frame: 2 weeks
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Bhayangkara Hospital
Makassar, South Celebes, Indonesia
RECRUITINGGatot Soebroto Army Hospital
Jakarta, Indonesia
RECRUITINGDr. Esnawan Antariksa Air Force Hospital
Jakarta, Indonesia
RECRUITINGSurvival
Death
Time frame: 2 months