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

Rohto Pharmaceutical Co., Ltd.6 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

Mesenchymal stem cellBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Osaka University Hospital

Suita, Osaka, Japan

Outcomes

Primary Outcomes

Safety: Adverse Event

Adverse events which appear in subjects with ADR-001 treatment are evaluated.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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