Study to Evaluate the Efficacy and Safety of AstroStem-V in Treatment of COVID-19 Pneumonia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04527224|
Recruitment Status : Recruiting
First Posted : August 26, 2020
Last Update Posted : October 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Pneumonia||Drug: AstroStem-V||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 24, 2022|
|Estimated Primary Completion Date :||November 1, 2023|
|Estimated Study Completion Date :||December 1, 2023|
AstroStem-V which consists of three syringes and each syringe contains 1.0 x 10^8 cells / 3mL of saline with 30% human serum
Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)
- Incidence of adverse events [ Time Frame: From baseline to Week 12 ]Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms.
- Abnormalities of physical examination, vital signs, and laboratory test [ Time Frame: From baseline to Week 12 ]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.
- SpO2 [ Time Frame: From baseline to Week 12 ]Change from baseline in SpO2 at every visit
- Mortality rate [ Time Frame: Week 4, Week 8, and Week 12 ]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.
- Ventilator treatment status [ Time Frame: From Week 1 to Week 12 ]Check the duration of the ventilator retention, check when the ventilator treatment has been completed after the baseline.
- Improvement of pneumonia assessed by radiologic examination(Chest X-ray or CT) [ Time Frame: From baseline to Week 12 ]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.
- SOFA score (Sequential Organ Failure Assessment) [ Time Frame: From baseline to Week 12 ]
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.
- 2019 nCOV nucleic acid test [ Time Frame: From baseline to Week 12 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04527224
|Contact: Hugh Leefirstname.lastname@example.org|
|Contact: Jane Shinemail@example.com|
|United States, Arizona|
|Medical Advancement Center of Arizona||Recruiting|
|Phoenix, Arizona, United States, 85283|
|Contact: Enrique M. Cifuentes Jr., M.D.|
|United States, Texas|
|Epic Medical Research||Recruiting|
|Dallas, Texas, United States, 75154|
|Contact: Boghara Haresh, M.D.|
|Study Director:||JeongChan Ra, Ph.D.||Nature Cell Co. Ltd.|