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

May 19, 2021 updated by: Agung Putra, Stem Cell and Cancer Research Indonesia

The Effect of Secretome of Hypoxia-Mesenchymal Stem Cells in Improving Survival of Severe Covid-19 Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bhirau Wilaksono, MD
  • Phone Number: +6285277777824
  • Email: bhirau@gmail.com

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10410
        • Recruiting
        • Gatot Soebroto Army Hospital
        • Contact:
        • Sub-Investigator:
          • Gunawan Dwi Prayitno, MD, Sp,OG KFER
      • Jakarta, Indonesia, 13610
        • Recruiting
        • Dr. Esnawan Antariksa Air Force Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sugeng Ibrahim, MD, M.Biomed (AAM)
    • Central Java
      • Bantul, Central Java, Indonesia
        • Recruiting
        • RSUD Bantul
        • Contact:
          • Yuni Iswati Raharjani, MD, Sp.P
          • Phone Number: 0811274816
      • Yogyakarta, Central Java, Indonesia, 55122
        • Recruiting
        • RS PKU Muhammadiyah Gamping
        • Contact:
        • Sub-Investigator:
          • Agus Widyatmoko, MD, Sp.PD
    • Jakarta
      • Bekasi, Jakarta, Indonesia
        • Recruiting
        • RS Primaya Bekasi Timur
        • Contact:
          • Muhammad Irhamsyah, MD, Sp.KK
          • Phone Number: 08114122999
        • Sub-Investigator:
          • Aditya Nugraha, MD, M.Biomed
    • South Celebes
      • Makassar, South Celebes, Indonesia
        • Recruiting
        • Bhayangkara Hospital
        • Contact:
          • Fajar Amansyah, MD, Sp.PD
          • Phone Number: +62853-4363-7775
        • Sub-Investigator:
          • Farid Amansyah, MD, Sp.PD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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: severe <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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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: 1 cc every 12 hours

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patients clinical manifestation
Time Frame: 1 months
mild, moderate, or severe
1 months
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
1 months
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
1 months
Length of stay
Time Frame: 1 months
The length of stay from the first treatment to the patient's final outcome, recovery, or death
1 months
Routine blood profile
Time Frame: 2 weeks
Obtained from patients before and after treatment
2 weeks
CRP
Time Frame: 2 weeks
Obtained from patients before and after treatment
2 weeks
D-dimer
Time Frame: 2 weeks
Obtained from patients before and after treatment
2 weeks
Blood Gas Analisis (BGA)
Time Frame: 2 weeks
Obtained from patients before and after treatment
2 weeks
Photo thorax
Time Frame: 2 weeks
Obtained from patients before and after treatment
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 2 months
Death
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stem Cell and Cancer Research Indonesia

Collaborators

Provincial Government of Central Java, Indonesia

Investigators

  • Principal Investigator: Agung Putra, Assoc.Prof, Stem Cell and Cancer Research Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 8, 2020

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

March 1, 2022

Study Registration Dates

First Submitted

February 11, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (ACTUAL)

February 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 19, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCCR_Secretome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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