Clinical trial NCT04527224: Study to Evaluate the Efficacy and Safety of AstroStem-V in Treatment of COVID-19 Pneumonia
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Covid19 Pneumonia
Lead sponsor: Nature Cell Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-08-26
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: From baseline to Week 12
measure: Abnormalities of physical examination, vital signs, and laboratory test
timeFrame: From baseline to Week 12
Secondary outcomes:
measure: SpO2
timeFrame: From baseline to Week 12
measure: Mortality rate
timeFrame: Week 4, Week 8, and Week 12
measure: Ventilator treatment status
timeFrame: From Week 1 to Week 12
measure: Improvement of pneumonia assessed by radiologic examination(Chest X-ray or CT)
timeFrame: From baseline to Week 12
measure: SOFA score (Sequential Organ Failure Assessment)
timeFrame: From baseline to Week 12
measure: 2019 nCOV nucleic acid test
timeFrame: From baseline to Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Medical Advancement Center of Arizona
state: Arizona
city: Dallas
country: United States
facility: Epic Medical Research
state: Texas
Study officials:
affiliation: Nature Cell Co. Ltd.
name: JeongChan Ra, Ph.D.
role: STUDY_DIRECTOR
References: