Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia
NCT ID: NCT04753476
Last Updated: 2021-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
48 participants
INTERVENTIONAL
2020-06-08
2022-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Secretome-MSCs (n=24)
This group will be given Covid-19 standard therapy with intramuscular Hypoxic S-MSC secretome
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
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
Standard treatment of Covid-19
Patients will be given Standard treatment of Covid-19 which accordance with National protocol
Interventions
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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
Standard treatment of Covid-19
Patients will be given Standard treatment of Covid-19 which accordance with National protocol
Eligibility Criteria
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Inclusion Criteria
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
2. ECOG 4 performance status, decreased irreversible consciousness, brain stem death.
3. Severe NYHA III / IV heart failure
4. Pregnant women
ALL
No
Sponsors
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Provincial Government of Central Java, Indonesia
UNKNOWN
Stem Cell and Cancer Research Indonesia
NETWORK
Responsible Party
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Agung Putra
Assoc. Prof. Dr. dr. Agung Putra, M.Si. Med
Principal Investigators
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Agung Putra, Assoc.Prof
Role: PRINCIPAL_INVESTIGATOR
Stem Cell and Cancer Research Indonesia
Locations
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RSUD Bantul
Bantul, Central Java, Indonesia
RS PKU Muhammadiyah Gamping
Yogyakarta, Central Java, Indonesia
RS Primaya Bekasi Timur
Bekasi, Jakarta Special Capital Region, Indonesia
Bhayangkara Hospital
Makassar, South Celebes, Indonesia
Gatot Soebroto Army Hospital
Jakarta, , Indonesia
Dr. Esnawan Antariksa Air Force Hospital
Jakarta, , Indonesia
Countries
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Central Contacts
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Facility Contacts
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Yuni Iswati Raharjani, MD, Sp.P
Role: primary
Muhammad Irhamsyah, MD, Sp.KK
Role: primary
Fajar Amansyah, MD, Sp.PD
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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SCCR_Secretome
Identifier Type: -
Identifier Source: org_study_id
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