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

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ClinicalTrials.gov Identifier: NCT04753476
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : February 17, 2021
Sponsor:
Collaborator:
Provincial Government of Central Java, Indonesia
Information provided by (Responsible Party):
Agung Putra, Stem Cell and Cancer Research Indonesia

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.

Condition or disease Intervention/treatment Phase
Covid-19 Cytokine Storm Biological: Injection of Secretome-MSCs Drug: Standard treatment of Covid-19 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Secretome of Hypoxia-Mesenchymal Stem Cells in Improving Survival of Severe Covid-19 Patients
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : June 8, 2021
Estimated Study Completion Date : August 8, 2021

Arm Intervention/treatment
Experimental: Secretome-MSCs (n=24)
This group will be given Covid-19 standard therapy with intramuscular Hypoxic S-MSC secretome
Biological: Injection of Secretome-MSCs

Injection of Hypoxic Secretome-MSCs intramuscular (deltoideus) :

Day 1: 1 cc every 12 hours

Day 2: 1 cc every 12 hours

Day 3: 0,5 cc every 12 hours


Drug: Standard treatment of Covid-19
Patients will be given Standard treatment of Covid-19 which accordance with National protocol

Control (n=24)
This group will receive standard Covid-19 therapy with the best supportive care
Drug: Standard treatment of Covid-19
Patients will be given Standard treatment of Covid-19 which accordance with National protocol




Primary Outcome Measures :
  1. Change in patients clinical manifestation [ Time Frame: 1 months ]
    mild, moderate, or severe

  2. Need for a ventilator [ Time Frame: 1 months ]

    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

  3. Duration of using a ventilator [ Time Frame: 1 months ]
    Duration of use of a ventilator from the day of intubation to the day of extubation

  4. Length of stay [ Time Frame: 1 months ]
    The length of stay from the first treatment to the patient's final outcome, recovery, or death

  5. Routine blood profile [ Time Frame: 2 weeks ]
    Obtained from patients before and after treatment

  6. CRP [ Time Frame: 2 weeks ]
    Obtained from patients before and after treatment

  7. D-dimer [ Time Frame: 2 weeks ]
    Obtained from patients before and after treatment

  8. Blood Gas Analisis (BGA) [ Time Frame: 2 weeks ]
    Obtained from patients before and after treatment

  9. Photo thorax [ Time Frame: 2 weeks ]
    Obtained from patients before and after treatment


Secondary Outcome Measures :
  1. Survival [ Time Frame: 2 months ]
    Death



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients whose clinical and laboratory test results have a positive diagnosis of Covid-19.
  2. Patients who are willing to participate as subjects in the study by signing the informed content.
  3. Criteria for Berlin to enter ARDS (moderate and severe) with or without a ventilator:

    • PaO2 / FiO2: moderate 100-200
    • PaO2 / FiO2: weight <100
  4. One or more comorbid history
  5. SOFA score

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04753476


Contacts
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Contact: Agung Putra, Assoc.Prof +628164251646 dr.agungptr@gmail.com
Contact: Bhirau Wilaksono, MD +6285277777824 bhirau@gmail.com

Locations
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Indonesia
Sultan Imanuddin Hospital Recruiting
Kalimantan, Central Borneo, Indonesia
Contact: Zainuddin Aziz, MD, Sp.P    +62812-3159-2216      
Charlie Hospital Recruiting
Kendal, Central Java, Indonesia
Contact: M Riza Setiawan, MD, MOSH    +62857-4199-4178      
RS PKU Muhammadiyah Yogyakarta Recruiting
Yogyakarta, Central Java, Indonesia, 55122
Contact: Agus Widyatmoko, MD, Sp.PD    +62813-2832-4539    aguswidi@umy.ac.id   
Sub-Investigator: Agus Widyatmoko, MD, Sp.PD         
Bhayangkara Hospital Recruiting
Makassar, South Celebes, Indonesia
Contact: Fajar Amansyah, MD, Sp.PD    +62853-4363-7775      
Sub-Investigator: Farid Amansyah, MD, Sp.PD         
Gatot Soebroto Army Hospital Recruiting
Jakarta, Indonesia, 10410
Contact: Basuki Rachmad, MD, Sp.An KIC    +62852-2022-2519    basukibanjarmasin1@gmail.com   
Sub-Investigator: Gunawan Dwi Prayitno, MD, Sp,OG KFER         
Dr. Esnawan Antariksa Air Force Hospital Recruiting
Jakarta, Indonesia, 13610
Contact: Crispinus Adhi Suryo, MD, Sp.An    +62812-9578-192    c.adhisuryo@gmail.com   
Contact: Flora Eka Sari, MD, Sp.P    +62821-1447-7473    floraeka86@gmail.com   
Sub-Investigator: Sugeng Ibrahim, MD, M.Biomed (AAM)         
Sponsors and Collaborators
Stem Cell and Cancer Research Indonesia
Provincial Government of Central Java, Indonesia
Investigators
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Principal Investigator: Agung Putra, Assoc.Prof Stem Cell and Cancer Research Indonesia
Publications of Results:
Other Publications:
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Responsible Party: Agung Putra, Assoc. Prof. Dr. dr. Agung Putra, M.Si. Med, Stem Cell and Cancer Research Indonesia
ClinicalTrials.gov Identifier: NCT04753476    
Other Study ID Numbers: SCCR_Secretome
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agung Putra, Stem Cell and Cancer Research Indonesia:
secretome
mesenchymal stem cells
covid-19
hypoxia
Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory