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

NCT ID: NCT04522986

Last Updated: 2024-12-09

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-21

Study Completion Date

2021-02-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Severe Acute Respiratory Syndrome Coronavirus 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenchymal stem cell

4 times dose of Mesenchymal stem cell

Group Type EXPERIMENTAL

Mesenchymal stem cell

Intervention Type BIOLOGICAL

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

Interventions

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Mesenchymal stem cell

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rohto Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuji Fujino, MD

Role: PRINCIPAL_INVESTIGATOR

Osaka University Hospital

Locations

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Osaka University Hospital

Suita, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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ADR-001-1919

Identifier Type: -

Identifier Source: org_study_id