An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04522986

Acronym

COVID-19

Enrollment

Registered

2020-08-21

Start date

2020-08-21

Completion date

2021-02-02

Last updated

2024-12-09

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

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Brief summary

Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.

Detailed description

Patients with Severe Pneumonia caused by SARS-CoV-2 infection are enrolled to the study. Adipose-derived mesenchymal stem cells (AD-MSCs) are administered once a week, total four times intravenously. Safety and efficacy of AD-MSCs are evaluated for 12 weeks after first administer.

Interventions

BIOLOGICALMesenchymal stem cell

1\*10\^8 cells are administered once a week, total four times intravenously.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* SARS-CoV-2 infection is confirmed on antigen test or PCR test * Pulmonary infiltrative shadow is confirmed on chest X-ray test * Mechanical ventilation is being utilized, or Acute Respiratory Failure whose PaO2 is not being achieved to 80 mmHg in spite of High-flow oxygen therapy

Exclusion criteria

* Continue treatment for Pneumonia before SARS-CoV-2 infection * SOFA score \>= 15 * Infection type on DIC diagnosis criteria \>= 4 * Deep Venous Thrombosis

Design outcomes

Primary

Measure	Time frame	Description
Safety: Adverse Event	12 weeks	Adverse events which appear in subjects with ADR-001 treatment are evaluated.

Countries

Japan

Outcome results

None listed

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