Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

Efficacy and Safety of Normoxic Allogenic Umbilical Cord Mesenchymal Stem Cells Administered as Adjuntive Treatment to Standard Treatment in Severe Patients With COVID-19

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05132972

Acronym

UCMSC

Enrollment

Registered

2021-11-24

Start date

2021-01-17

Completion date

2021-11-30

Last updated

2021-11-24

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

Conditions

Covid 19

Keywords

COVID19, Mesenchymal Stem Cells (MCSs), Adjuvant therapy, Indonesia

Brief summary

This study is conducted to assess the efficacy and safety of stem cells as adjunctive treatment for severe COVID-19 patients. Here, we want to study whether the administration of mesenchymal stem cells are safe and able to relieve some of the COVID-19 symptoms

Detailed description

This is a randomized controlled trial. double-blind, multi-center clinical study conducted at three different hospitals, on 21 patients who received intervention and 21 patients who received control treatment. The purpose of this study is to evaluate the efficacy and safety of intravenous administration of normoxic allogeneic umbilical cord-derived mesenchymal stem cell (UCMSC) in the treatment group, compared to the control group who are only given standard COVID-19 treatments and normal saline infusion

Interventions

BIOLOGICALNormoxic Allogenic UCMSC

Allogenic umbilical cord-derived mesenchymal stem cell (UCMSC) from normoxic, culture condition, administered through intravenousinfusion at dose 1x10\^6 cells MSC/kg body weight. The treatment will be administered three times, at three days intervals (day 0, day 3, and day 6)

OTHERNormal saline solution

Sterile saline solution and adminastered through intravenous infusion three times, at three day intervals (day 0, day 3, and day 6)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Man or woman age 18-75 years * SARS-CoV2 positive as confirmed by SARS-CoV2 RT-PCR Test * Diagnosed with pnumonia as confirmed by chect radiography and history of fever, coug with one of the following symptoms: RR \> 30x per minute, SaO2 93%, FaO2/FiO2 300 mmHg * Voluntarily joined the clinical trial and has signed the informed consent form

Exclusion criteria

* Pregnant and lactating woman * Patient who are diagnosed or have history of tumor and cancer * Patient whose mother or sister are diagnosed with breast or ovarian cancer * Level of SGPT/ALT is ≥ 5 times upper limit from normal value * Level of eGFR is \< 30 ml/min * Reluctant to sign informed consent and unwilling to take the required tests * Require invasive ventilation * Shock * Organ failure * Currently involve in other clinical trial, or join another clinical trial in the last 3 months

Design outcomes

Primary

Measure	Time frame	Description
Duration of hospital stay	20 - 24 days	Number of days since patient was administered until discharge in hospitals

Secondary

Measure	Time frame	Description
Post-administration clinical and radiological improvement	Baseline/day-1 (-2 days), day-15 (+/- 2 days), day-22 (+/1 2 days) post randomization day	Chest X-ray evaluation; mMRC(Modified Medical Research Council) Dyspnea scale;
Adverse Event and Serious Adverse Event Evaluation	20 - 24 days	Evaluation of all adverse event or serious adverse event that is observed or reported by

Countries

Indonesia

Contacts

Primary ContactBintang Soetjahjo, MD PhD

bjortho@yahoo.com+628122987359

Outcome results

None listed

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