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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

Tracking Information
First Submitted Date  ICMJE February 11, 2021
First Posted Date  ICMJE February 15, 2021
Last Update Posted Date February 17, 2021
Actual Study Start Date  ICMJE June 8, 2020
Estimated Primary Completion Date June 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2021)
  • Change in patients clinical manifestation [ Time Frame: 1 months ]
    mild, moderate, or severe
  • 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
  • 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
  • Length of stay [ Time Frame: 1 months ]
    The length of stay from the first treatment to the patient's final outcome, recovery, or death
  • Routine blood profile [ Time Frame: 2 weeks ]
    Obtained from patients before and after treatment
  • CRP [ Time Frame: 2 weeks ]
    Obtained from patients before and after treatment
  • D-dimer [ Time Frame: 2 weeks ]
    Obtained from patients before and after treatment
  • Blood Gas Analisis (BGA) [ Time Frame: 2 weeks ]
    Obtained from patients before and after treatment
  • Photo thorax [ Time Frame: 2 weeks ]
    Obtained from patients before and after treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2021)
Survival [ Time Frame: 2 months ]
Death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia
Official Title  ICMJE The Effect of Secretome of Hypoxia-Mesenchymal Stem Cells in Improving Survival of Severe Covid-19 Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Covid-19
  • Cytokine Storm
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Secretome-MSCs (n=24)
    This group will be given Covid-19 standard therapy with intramuscular Hypoxic S-MSC secretome
    Interventions:
    • Biological: Injection of Secretome-MSCs
    • Drug: Standard treatment of Covid-19
  • Control (n=24)
    This group will receive standard Covid-19 therapy with the best supportive care
    Intervention: Drug: Standard treatment of Covid-19
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 12, 2021)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 8, 2021
Estimated Primary Completion Date June 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Agung Putra, Assoc.Prof +628164251646 dr.agungptr@gmail.com
Contact: Bhirau Wilaksono, MD +6285277777824 bhirau@gmail.com
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04753476
Other Study ID Numbers  ICMJE SCCR_Secretome
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Agung Putra, Stem Cell and Cancer Research Indonesia
Study Sponsor  ICMJE Stem Cell and Cancer Research Indonesia
Collaborators  ICMJE Provincial Government of Central Java, Indonesia
Investigators  ICMJE
Principal Investigator: Agung Putra, Assoc.Prof Stem Cell and Cancer Research Indonesia
PRS Account Stem Cell and Cancer Research Indonesia
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP