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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05122234

Enrollment

Registered

2021-11-16

Start date

2020-08-10

Completion date

2021-11-14

Last updated

2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Severe Covid-19, secretome, mesenchymal stem cell, cytokine

Brief summary

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.

Interventions

BIOLOGICALInjection 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.

OTHERPlacebo

Normal saline

DRUGStandard treatment of Covid-19

Standard treatment of Covid-19 based on national protocol.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of inflamation marker levels	Day 0 (before intervention), day 7, day 14	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.

Secondary

Measure	Time frame	Description
Assessment of clinical outcome	before and after intervention (maximum 14 days after intervention)	Clinical outcome assessed in this study were body temperature, oxygen saturation, respiratory rate, shortness of breath, cough, and phlegm on cough.
Assessment of laboratory routine	before and after intervention (maximum 14 days after intervention)	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.
Assessment of photo thorax	before and after intervention (maximum 14 days after intervention)	Photo thorax will assess before and after intervention
Assessment of RT-PCR conversion	before and after intervention (maximum 14 days after intervention)	RT-PCR conversion will assess before and after intervention
Mortality rate	maximum 14 days after intervention	—

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026