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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AstroStem-V | Experimental | AstroStem-V which consists of three syringes and each syringe contains 1.0 x 10^8 cells / 3mL of saline with 30% human serum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AstroStem-V | Drug | Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs) |
|
| 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 |
| 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. |
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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 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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hugh Lee | Contact | 301-540-260 | hughlee@kcrnresearch.com | |
| Jane Shin | Contact | 213-797-2655 | jane.shin@stemcellbio.us |
| Name | Affiliation | Role |
|---|---|---|
| JeongChan Ra, Ph.D. | Nature Cell Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Advancement Center of Arizona | Recruiting | Phoenix | Arizona | 85283 | United States |
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| 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 |
| Epic Medical Research | Recruiting | Dallas | Texas | 75154 | United States |
|