Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia

Last updated: May 19, 2021
Sponsor: Stem Cell and Cancer Research Indonesia
Overall Status: Active - Recruiting

Phase

2

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT04753476
SCCR_Secretome
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients whose clinical and laboratory test results have a positive diagnosis ofCovid-19.
  2. Patients who are willing to participate as subjects in the study by signing theinformed content.
  3. Criteria for Berlin to enter ARDS (moderate and severe) with or without a ventilator:
  • PaO2 / FiO2: moderate 100-200
  • PaO2 / FiO2: severe <100
  1. One or more comorbid history
  2. SOFA score

Exclusion

Exclusion Criteria:

  1. The Covid19 patient has fibrosis (based on the results of the chest X-ray or CT chest)
  2. ECOG 4 performance status, decreased irreversible consciousness, brain stem death.
  3. Severe NYHA III / IV heart failure
  4. Pregnant women

Study Design

Total Participants: 48
Study Start date:
June 08, 2020
Estimated Completion Date:
March 01, 2022

Study 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.

Connect with a study center

  • Sultan Imanuddin Hospital

    Kalimantan, Central Borneo
    Indonesia

    Site Not Available

  • RSUD Bantul

    Bantul, Central Java
    Indonesia

    Active - Recruiting

  • Charlie Hospital

    Kendal, Central Java
    Indonesia

    Site Not Available

  • RS PKU Muhammadiyah Gamping

    Yogyakarta, Central Java 55122
    Indonesia

    Active - Recruiting

  • RS Primaya Bekasi Timur

    Bekasi, Jakarta
    Indonesia

    Active - Recruiting

  • Bhayangkara Hospital

    Makassar, South Celebes
    Indonesia

    Active - Recruiting

  • Dr. Esnawan Antariksa Air Force Hospital

    Jakarta, 13610
    Indonesia

    Active - Recruiting

  • Gatot Soebroto Army Hospital

    Jakarta, 10410
    Indonesia

    Active - Recruiting

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