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

Covid19 Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04527224
• Other study ID #: ASVP1N2A-US
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 24, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Nature Cell Co. Ltd.
• Contact: Hugh Lee
• Phone: 301-540-260
• Email: hughlee[@]kcrnresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19 Pneumonia
• Pneumonia

Intervention

Drug:
• AstroStem-V
Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)

Locations

Country	Name	City	State
United States	Epic Medical Research	Dallas	Texas
United States	Medical Advancement Center of Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Nature Cell Co. Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	SpO2	Change from baseline in SpO2 at every visit	From baseline to Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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