MedDataX Logo

Mesenchymal Stem Cell Secretome In Severe Cases of COVID-19

NCT ID: NCT05122234

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-10

Study Completion Date

2021-11-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Severe Covid-19 secretome mesenchymal stem cell cytokine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Secretome - mesenchymal stem cell group (n = 20)

This group will be given secretome - mesenchymal stem cell and COVID-19 standard therapy

Group Type EXPERIMENTAL

Injection of secretome - mesenchymal stem cell

Intervention Type BIOLOGICAL

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.

Standard treatment of Covid-19

Intervention Type DRUG

Standard treatment of Covid-19 based on national protocol.

Control ( n= 20)

This group will be given placebo and COVID-19 standard therapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Normal saline

Standard treatment of Covid-19

Intervention Type DRUG

Standard treatment of Covid-19 based on national protocol.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

Placebo

Normal saline

Intervention Type OTHER

Standard treatment of Covid-19

Standard treatment of Covid-19 based on national protocol.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Murdani abdullah

Prof. M.D., PhD, FACG, FASGE

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Murdani Abdullah, Prof. M.D., PhD, FACG, FASGE

Role: PRINCIPAL_INVESTIGATOR

Departemen of Internal Medicine, Faculty of Medicine, University of Indonesia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

RSUP Fatmawati

Jakarta, DKI Jakarta, Indonesia

Site Status

RSUP Persahabatan

Jakarta, DKI Jakarta, Indonesia

Site Status

RSUPN Dr. Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Rumah Sakit Universitas Indonesia

Depok, West Java, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

54/FI/P-KCOVID-19.2B3/IX/2020

Identifier Type: -

Identifier Source: org_study_id