Status:
UNKNOWN
Bone Marrow-Derived Mesenchymal Stem Cell Treatment for Severe Patients With Coronavirus Disease 2019 (COVID-19)
Lead Sponsor:
Guangzhou Institute of Respiratory Disease
Collaborating Sponsors:
Guangzhou Eighth People's Hospital
Tongji Hospital
Conditions:
Coronavirus Disease 2019 (COVID-19)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Coronavirus Disease 2019 (COVID-19) is spreading worldwide and has become a public health emergency of major international concern. Currently, no specific drugs or vaccines are available. For severe c...
Detailed Description
COVID-19 has become a urgent and serious public health event that threatens human life and health globally. No specific pharmacological treatments are available to date for COVID-19.Patients contracti...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent prior to performing study procedures
- Age ≥18 years, and ≤75 years;
- A confirmed case of Covid-19. The criteria are as follows:
- Clinically diagnosed or suspected cases with one of the following etiological evidence: 1) SARS-CoV-2 nucleic acid is positive in respiratory or blood samples detected by RT-PCR; 2) virus sequence detected in respiratory or blood samples shares high homology with the known sequence of SARS-CoV-2.
- Clinical classification is severe case: Meet any of the following:
- 1\) Increased respiratory rate (≥30 beats / min), difficulty breathing, cyanosis of the lips; 2) Peripheral capillary oxygen saturation (SpO2) ≤93% at rest ; 3)Partial pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) ≤300 mmHg (1mmHg = 0.133kPa).
Exclusion
- Other types of viral pneumonia, or bacterial pneumonia.
- The clinical classification is mild, moderate or critical;
- Patients with malignant blood or solid tumor.
- Pregnant or lactating women;
- There are other situations or diseases that the investigator think are not suitable to participate in this clinical study or may be increased risk of the subject.
- Patients with serious social and mental disability, inability/restriction of legal capacity;
- Refusal to sign informed consent;
- Patients with severe liver disease (eg Child Pugh score ≥ C, AST\> 5 times upper limit of normal );
- Patients with severe renal insufficiency (estimated glomerular filtration rate ≤30mL / min / 1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04346368
Start Date
April 1 2020
End Date
December 1 2020
Last Update
April 15 2020
Active Locations (1)
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1
Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120