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

NCT04753476 | Unknown Phase 2 DMC

• 1 other identifier: SCCR_Secretome
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

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.

Conditions

Covid-19; Cytokine Storm

Keywords

secretome; mesenchymal stem cells; covid-19; hypoxia

Outcome Measures

Primary Outcomes (9)

• Change in patients clinical manifestation

  mild, moderate, or severe

  1 months

• 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

  1 months

• Duration of using a ventilator

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

  1 months

• Length of stay

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

  1 months

• Routine blood profile

  Obtained from patients before and after treatment

  2 weeks

• CRP

  Obtained from patients before and after treatment

  2 weeks

• D-dimer

  Obtained from patients before and after treatment

  2 weeks

• Blood Gas Analisis (BGA)

  Obtained from patients before and after treatment

  2 weeks

• Photo thorax

  Obtained from patients before and after treatment

  2 weeks

Secondary Outcomes (1)

• Survival

  2 months

Study Arms (2)

Secretome-MSCs (n=24)

EXPERIMENTAL

This group will be given Covid-19 standard therapy with intramuscular Hypoxic S-MSC secretome

Biological: Injection of Secretome-MSCs; Drug: Standard treatment of Covid-19

Control (n=24)

OTHER

This group will receive standard Covid-19 therapy with the best supportive care

Drug: Standard treatment of Covid-19

Interventions

Injection of Secretome-MSCs BIOLOGICAL

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

Secretome-MSCs (n=24)

Standard treatment of Covid-19 DRUG

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

Control (n=24); Secretome-MSCs (n=24)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stem Cell and Cancer Research Indonesia: lead
• Provincial Government of Central Java, Indonesia: collaborator

Study Sites (6)

RSUD Bantul

Bantul, Central Java, Indonesia

RECRUITING

RS PKU Muhammadiyah Gamping

Yogyakarta, Central Java, 55122, Indonesia

RECRUITING

RS Primaya Bekasi Timur

Bekasi, Jakarta Special Capital Region, Indonesia

RECRUITING

Bhayangkara Hospital

Makassar, South Celebes, Indonesia

RECRUITING

Gatot Soebroto Army Hospital

Jakarta, 10410, Indonesia

RECRUITING

Dr. Esnawan Antariksa Air Force Hospital

Jakarta, 13610, Indonesia

RECRUITING

Related Publications (6)

• 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.

  PMID: 31986264 BACKGROUND

• 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.

  PMID: 32105632 BACKGROUND

• 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.

  PMID: 24781370 BACKGROUND

• 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.

  PMID: 30341012 BACKGROUND

• 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.

  PMID: 33274176 RESULT

• 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.

  PMID: 32747157 RESULT

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome; Hypoxia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Agung Putra, Assoc.Prof

  Stem Cell and Cancer Research Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agung Putra, Assoc.Prof

CONTACT

+628164251646; dr.agungptr@gmail.com

Bhirau Wilaksono, MD

CONTACT

+6285277777824; bhirau@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr. dr. Agung Putra, M.Si. Med

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 15, 2021
• Study Start: June 8, 2020
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

ID (6)