Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

Effectiveness and Safety Profile of Mesenchymal Stem Cell Secretomes as a Treatment for Severe Cases of COVID-19

This study is a multi-centre randomized controlled trial involving severe covid-19 patients. The intervention group will receive mesenchymal stem cell secretomes and standard covid-19 therapy, while the control group receive placebo and standard covid-19 therapy. Clinical presentation, inflamatory marker, laboratory and radiological parameters, RT-PCR conversion, safety profile, and mortality rate will be monitored for a maximum of 14 days after intervention.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Placebo; Biological: Injection of secretome - mesenchymal stem cell; Drug: Standard treatment of Covid-19

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia
      • RSUP Fatmawati
    • Jakarta, DKI Jakarta, Indonesia
      • RSUP Persahabatan
    • Jakarta Pusat, DKI Jakarta, Indonesia
      • RSUPN Dr. Cipto Mangunkusumo
  • Jawa Barat
    • Depok, Jawa Barat, Indonesia
      • Rumah Sakit Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All individuals aged 18 to 65 years
2. It has been confirmed positive for COVID-19 by throat swab / sputum / brochoalveolar lavage (BAL) with real-time reverse transcription polymerase chain reaction (RT-PCR)
3. Categorized as a severe case of COVID-19 patient
4. Agree to participate and sign the informed consent

Exclusion Criteria:

1. History of allergy to penicillin, streptomycin, and amphotericin-B
2. Have any cancer conditions
3. Active in other intervention studies
4. Have had other intervention studies in the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Secretome - mesenchymal stem cell group (n = 20); This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy	Biological: Injection of secretome - mesenchymal stem cell; Secretome will be given once at a dose of 15 ml per administration dissolved in 100 ml of normal saline. The administration is done intravenously for 60 minutes.; Drug: Standard treatment of Covid-19; Standard treatment of Covid-19 based on national protocol.
Placebo Comparator: Control ( n= 20); This group will be given placebo and COVID-19 standard therapy	Other: Placebo; Normal saline; Drug: Standard treatment of Covid-19; Standard treatment of Covid-19 based on national protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of inflamation marker levels	The inflamatory marker assessed in this study is IL-6, IL-10, LIF, VEGF, and Ferritin. The inflamatory marker level will assess on day 0 (before intervention), day 7 after intervention, and day 14 after intervention.	Day 0 (before intervention), day 7, day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of clinical outcome	Clinical outcome assessed in this study were body temperature, oxygen saturation, respiratory rate, shortness of breath, cough, and phlegm on cough.	before and after intervention (maximum 14 days after intervention)
Assessment of laboratory routine	Laboratory routine assessed in this study is NLR, lymphocyte count, thrombocytes count, CRP, blood gas analysis, bilirubin, albumin, SGOT, SGPT, ureum/creatinin, glomerular filtration rate (GFR), electrolyte, myoglobin, troponin, D-dimer.	before and after intervention (maximum 14 days after intervention)
Assessment of photo thorax	Photo thorax will assess before and after intervention	before and after intervention (maximum 14 days after intervention)
Assessment of RT-PCR conversion	RT-PCR conversion will assess before and after intervention	before and after intervention (maximum 14 days after intervention)
Mortality rate		maximum 14 days after intervention

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE, Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2020
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): November 14, 2021

Study Registration Dates

• First Submitted: November 13, 2021
• First Submitted That Met QC Criteria: November 13, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: cytokine; mesenchymal stem cell; secretome; Severe Covid-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 54/FI/P-KCOVID-19.2B3/IX/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No