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Covid-19Phase 2NCT04753476

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

A Phase 2 study testing Injection of Secretome-MSCs and Standard treatment of Covid-19 in people with Covid-19 and Cytokine Storm, run by Stem Cell and Cancer Research Indonesia at 6 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Covid-19, Cytokine Storm
What is being tested?
Injection of Secretome-MSCs and Standard treatment of Covid-19
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
6 sitesIndonesia
Study dates
8 Jun 2020to 1 Mar 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

Agung Putra, Assoc.Prof contact

+628164251646

dr.agungptr@gmail.com

Bhirau Wilaksono, MD contact

+6285277777824

bhirau@gmail.com

6 sites in 1 country

Indonesia6 sites, 6 recruiting

  • RSUD Bantul

    Bantul, Central Java

    Yuni Iswati Raharjani, MD, Sp.P, 0811274816

    Recruiting

  • RS Primaya Bekasi Timur

    Bekasi, Jakarta Special Capital Region

    Muhammad Irhamsyah, MD, Sp.KK, 08114122999

    Aditya Nugraha, MD, M.Biomed

    Recruiting

  • Gatot Soebroto Army Hospital

    Jakarta, 10410

    Basuki Rachmad, MD, Sp.An KIC, +62852-2022-2519, basukibanjarmasin1@gmail.com

    Gunawan Dwi Prayitno, MD, Sp,OG KFER

    Recruiting

  • Dr. Esnawan Antariksa Air Force Hospital

    Jakarta, 13610

    Crispinus Adhi Suryo, MD, Sp.An, +62812-9578-192, c.adhisuryo@gmail.com

    Flora Eka Sari, MD, Sp.P, +62821-1447-7473, floraeka86@gmail.com

    Recruiting

  • Bhayangkara Hospital

    Makassar, South Celebes

    Fajar Amansyah, MD, Sp.PD, +62853-4363-7775

    Farid Amansyah, MD, Sp.PD

    Recruiting

  • RS PKU Muhammadiyah Gamping

    Yogyakarta, Central Java, 55122

    Agus Widyatmoko, MD, Sp.PD, +62813-2832-4539, aguswidi@umy.ac.id

    Agus Widyatmoko, MD, Sp.PD

    Recruiting

Other trials in Indonesia

About this study

Official title: 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.

Read the 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.

Being tested
Injection of Secretome-MSCs, Standard treatment of Covid-19
Keywords
secretome, mesenchymal stem cells, covid-19, hypoxia
Medical subject headings
COVID-19, Cytokine Release Syndrome, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injection of Secretome-MSCsBiological

    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

  • Standard treatment of Covid-19Drug

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

Study groups in NCT04753476
Study groupRoleWhat they receive
Secretome-MSCs (n=24)ExperimentalThis group will be given Covid-19 standard therapy with intramuscular Hypoxic S-MSC secretome
Receives: Biological: Injection of Secretome-MSCs; Drug: Standard treatment of Covid-19
Control (n=24)OtherThis group will receive standard Covid-19 therapy with the best supportive care
Receives: Drug: Standard treatment of Covid-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in patients clinical manifestation

    mild, moderate, or severe

    Measured: 1 months

  2. 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

    Measured: 1 months

  3. Duration of using a ventilator

    Duration of use of a ventilator from the day of intubation to the day of extubation

    Measured: 1 months

  4. Length of stay

    The length of stay from the first treatment to the patient's final outcome, recovery, or death

    Measured: 1 months

  5. Routine blood profile

    Obtained from patients before and after treatment

    Measured: 2 weeks

  6. CRP

    Obtained from patients before and after treatment

    Measured: 2 weeks

  7. D-dimer

    Obtained from patients before and after treatment

    Measured: 2 weeks

  8. Blood Gas Analisis (BGA)

    Obtained from patients before and after treatment

    Measured: 2 weeks

  9. Photo thorax

    Obtained from patients before and after treatment

    Measured: 2 weeks

Secondary outcomes (1)

  1. Survival

    Death

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2021
  2. Study start8 Jun 2020
  3. Primary completion1 Feb 2022 (estimated)
  4. Study completion1 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04753476
Sponsor's protocol ID
SCCR_Secretome
Status last verified
May 2021
First submitted
11 Feb 2021
Last updated
24 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

    PubMed 31986264

  • Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.

    PubMed 32105632

  • Chen L, Xu Y, Zhao J, Zhang Z, Yang R, Xie J, Liu X, Qi S. Conditioned medium from hypoxic bone marrow-derived mesenchymal stem cells enhances wound healing in mice. PLoS One. 2014 Apr 29;9(4):e96161. doi: 10.1371/journal.pone.0096161. eCollection 2014.

    PubMed 24781370

  • Haraszti RA, Miller R, Stoppato M, Sere YY, Coles A, Didiot MC, Wollacott R, Sapp E, Dubuke ML, Li X, Shaffer SA, DiFiglia M, Wang Y, Aronin N, Khvorova A. Exosomes Produced from 3D Cultures of MSCs by Tangential Flow Filtration Show Higher Yield and Improved Activity. Mol Ther. 2018 Dec 5;26(12):2838-2847. doi: 10.1016/j.ymthe.2018.09.015. Epub 2018 Sep 22.

    PubMed 30341012

  • Harrell CR, Jovicic BP, Djonov V, Volarevic V. Therapeutic Potential of Mesenchymal Stem Cells and Their Secretome in the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome. Anal Cell Pathol (Amst). 2020 Nov 20;2020:1939768. doi: 10.1155/2020/1939768. eCollection 2020.

    PubMed 33274176

  • Johnson BS, Laloraya M. A cytokine super cyclone in COVID-19 patients with risk factors: the therapeutic potential of BCG immunization. Cytokine Growth Factor Rev. 2020 Aug;54:32-42. doi: 10.1016/j.cytogfr.2020.06.014. Epub 2020 Jul 1.

    PubMed 32747157

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Injection of Secretome-MSCs and Standard treatment of Covid-19 in people with Covid-19 and Cytokine Storm, run by Stem Cell and Cancer Research Indonesia at 6 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Agung Putra, Assoc.Prof (+628164251646, dr.agungptr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patients clinical manifestation (time frame: 1 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04753476, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.

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