Umbilical cord-derived mesenchymal stromal cells therapy for SARS-CoV-2 infection (COVID-19) related Acute Respiratory Distress Syndrome

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080225369

Enrollment

Registered

2020-08-27

Start date

2020-12-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

SARS-CoV-2 infection(COVID-19) related Acute Respiratory Distress Syndrome (ARDS)

Interventions

investigational material(s) Generic name etc : umbilical cord-derived mesenchymal stromal cells INN of investigational material : Therapeutic category code : Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: SARS-CoV-2 positive with RT-PCR test or antigen test. ARDS as defined by the Berlin definition. Receiving standard of care for COVID-19 and ARDS.

Exclusion criteria

Exclusion criteria: Receiving immunosuppressant drug except steroids. Increased dose of steroids. Malignant tumor, Acute myocardial infarction, Pulmonary hypertension, Dialysis. Not SARS-CoV-2 infection.

Design outcomes

Primary

Measure	Time frame
safety Dose Limiting Toxicity (Time Frame: Days 28 after the last administration)	—

Secondary

Measure	Time frame
safety efficacy Safety: Adverse Events (Time Frame: Days 56 after the last administration) Efficacy: 7 category ordinal scale The National Early Warning Score (NEWS) 2 Performance Status (PS) Length of hospital stay Mortality Length of oxygen therapy Length of mechanical ventilation or non-invasive positive pressure ventilation use PaO2/FiO2 Evaluation with chest X-ray or CT SARS-CoV-2 quantitative test	—

Measure

Time frame

safety efficacy Safety: Adverse Events (Time Frame: Days 56 after the last administration) Efficacy: 7 category ordinal scale The National Early Warning Score (NEWS) 2 Performance Status (PS) Length of hospital stay Mortality Length of oxygen therapy Length of mechanical ventilation or non-invasive positive pressure ventilation use PaO2/FiO2 Evaluation with chest X-ray or CT SARS-CoV-2 quantitative test

—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026