An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection
Phase 1
Completed
- Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2
- Interventions
- Biological: Mesenchymal stem cell
- Registration Number
- NCT04522986
- Lead Sponsor
- Rohto Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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
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Exclusion Criteria
- Continue treatment for Pneumonia before SARS-CoV-2 infection
- SOFA score >= 15
- Infection type on DIC diagnosis criteria >= 4
- Deep Venous Thrombosis
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mesenchymal stem cell Mesenchymal stem cell 4 times dose of Mesenchymal stem cell
- Primary Outcome Measures
Name Time Method Safety: Adverse Event 12 weeks Adverse events which appear in subjects with ADR-001 treatment are evaluated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Osaka University Hospital
🇯🇵Suita, Osaka, Japan