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.
Biological: Mesenchymal stem cell
1*10^8 cells are administered once a week, total four times intravenously.
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
Osaka University Hospital
Suita, Osaka, Japan
Yuji Fujino, MD, Principal Investigator
Osaka University Hospital