Study to Evaluate the Efficacy and Safety of AstroStem-V in Treatment of COVID-19 Pneumonia

Study Overview
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Brief Summary
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This study is an open-label, single-arm study to evaluate the safety and efficacy of Astrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patients with COVID-19 pneumonia. After each subject completes 12-Weeks visit (Visit 12) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.

Official Title
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A Phase I/Ⅱa Trial to Explore the Safety and Efficacy of Allogenic Adipose Tissue-derived Mesenchymal Stem Cell (AstroStem-V) Therapy in Patients With COVID-19 Pneumonia

Conditions
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Covid19 Pneumonia

Intervention / Treatment
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* Drug: AstroStem-V


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 19 to 80 years at the time of signing the written consent form Subjects diagnosed with pneumonia by radiologic examination (Chest X-ray or CT) at screening and baseline subject who has moderate COVID-19 disease: Subjects have laboratory-confirmed SARS-CoV-2 infection within 28 days from screening by authorized a reverse-transcription polymerase chain reaction (RT-PCR) or equivalent testing at baseline A subject who has symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion A subject who has clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≤ 20 breaths per minute, SpO2 ≥ 93% on room air at sea level, heart rate ≤ 90 beats per minute No clinical signs indicative of severe COVID-19 disease severity Subjects voluntarily participate in the clinical trial with written informed consent Exclusion Criteria: Subjects who have pulmonary disease except COVID-19 pneumonia SpO2 ≤ 93% Subjects who have uncontrolled shock Subjects diagnosed with COVID-19 with CPR or requires treatment of Extra Corporeal Membrane Oxygenation (ECMO) Subjects with an irreversible brain lesion or medical history of malignant tumors Subjects treated for heart disease within 3 months prior to screening Subjects who are receiving immunosuppressant therapy for transplantation or who are taking immunosuppressive drugs such as steroids, TNF-alpha inhibitors Subject treated with stem cells. Subjects with end-stage renal failure who need renal replacement therapy or cirrhosis patients with complications Subjects who have an average life expectancy to be less than 2 months due to the underlying disease Subjects who have history of thromboembolism or pulmonary arterial hypertension Subjects who currently have positive HIV test results Pregnant or breast-feeding women Subjects with pregnancy planned during clinical trials. Women or men of childbearing age who do not agree to maintain contraception by choosing, or who do not agree to use the appropriate method of contraception suitable contraceptive methods: condom, sponge, foam, gel, diaphragm for contraception, intrauterine device, etc. Periodic abstinence (eg, calendar method, ovulation method, symptom body temperature method, post ovulation method) and restraint is not considered an accepted method of contraception, and hormonal contraceptives are not allowed. However, women having no potential are pregnancy due to menopause (amenorrhea more than 12 months after the last menstruation) or surgical infertility is possible to participate in the study only the pregnancy test is negative Subjects who administered other investigational products within 12 weeks prior to IP administration Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above Subjects who cannot tolerate aspirin

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AstroStem-V<br>AstroStem-V which consists of three syringes and each syringe contains 1.0 x 10^8 cells / 3mL of saline with 30% human serum | Drug: AstroStem-V<br>* Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms. | From baseline to Week 12 | 
| Abnormalities of physical examination, vital signs, and laboratory test | Number of subjects with treatment related adverse events as assessed by analysis of adverse events including abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination. | From baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpO2 | Change from baseline in SpO2 at every visit | From baseline to Week 12 | 
| Mortality rate | Check survival status of the subject at Visit 6, 10(Week 4, 8 and Week 12 if follow-up is possible) and record the status on eCRF. | Week 4, Week 8, and Week 12 | 
| Ventilator treatment status | Check the duration of the ventilator retention, check when the ventilator treatment has been completed after the baseline. | From Week 1 to Week 12 | 
| Improvement of pneumonia assessed by radiologic examination(Chest X-ray or CT) | Perform chest X-ray every week (W1-W12) after screening, baseline, and W1 followed by 2-week intervals (W1, W2, W4, W6, W8, W12). In addition, CT is measured at week baseline, W4, W8 and W12. | From baseline to Week 12 | 
| SOFA score (Sequential Organ Failure Assessment) | Check the SOFA score every week (W1-W12) after baseline, and W1 followed by 2-week intervals (W1, W2, W4, W6, W8, W12). Choose the worst of the six physiological measurements and score between 0 and 4 points each and check the total. If the measured value is more than 3 points, it is defined as organ failure. | From baseline to Week 12 | 
| 2019 nCOV nucleic acid test | The Real-time PCR (RT-PCR) test for COVID-19 is measured at 2-week intervals (W1-W12) from Screening, Baseline to W1, W2, W4, W6, W8 and W12. | From baseline to Week 12 |