COVID-19: An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection
Study Details
Study Description
Brief Summary
Safety and efficacy of ADR-001 are evaluated in Patients with Severe Pneumonia caused by SARS-CoV-2 infection.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 1 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Mesenchymal stem cell 4 times dose of Mesenchymal stem cell |
Biological: Mesenchymal stem cell
1*10^8 cells are administered once a week, total four times intravenously.
|
Outcome Measures
Primary Outcome Measures
- Safety: Adverse Event [12 weeks]
Adverse events which appear in subjects with ADR-001 treatment are evaluated.
Eligibility Criteria
Criteria
Inclusion Criteria:
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SARS-CoV-2 infection is confirmed on antigen test or PCR test
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Pulmonary infiltrative shadow is confirmed on chest X-ray test
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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:
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Continue treatment for Pneumonia before SARS-CoV-2 infection
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SOFA score >= 15
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Infection type on DIC diagnosis criteria >= 4
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Deep Venous Thrombosis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Osaka University Hospital | Suita | Osaka | Japan | 565-0871 |
Sponsors and Collaborators
- Rohto Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Yuji Fujino, MD, Osaka University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADR-001-1919