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.
Drug: AstroStem-V
Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)
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
Medical Advancement Center of Arizona
Phoenix, Arizona, United States
Epic Medical Research
Dallas, Texas, United States
Hugh Lee
301-540-260
hughlee@kcrnresearch.com
Jane Shin
213-797-2655
jane.shin@stemcellbio.us
JeongChan Ra, Ph.D., Study Director
Nature Cell Co. Ltd.