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

• ClinicalTrials.gov Identifier: NCT04527224
• Recruitment Status: Recruiting
• First Posted: August 26, 2020
• Last Update Posted: January 10, 2023
• Sponsor: Nature Cell Co. Ltd.
• Information provided by (Responsible Party): Nature Cell Co. Ltd.

Tracking Information

• First Submitted Date: August 21, 2020
• First Posted Date: August 26, 2020
• Last Update Posted Date: January 10, 2023
• Actual Study Start Date: October 24, 2022
• Estimated Primary Completion Date: November 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 21, 2022)

• 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.

Original Primary Outcome Measures (submitted: August 24, 2020)

• Treatment related 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.
• Number of subjects with treatment related abnormal variation of vital signs, physical examination and laboratory test values [ 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.

Current Secondary Outcome Measures (submitted: September 26, 2022)

• 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.

Original Secondary Outcome Measures (submitted: August 24, 2020)

• Oxygenation index (PaO2 / FiO2 ratio) [ Time Frame: From baseline to Week 12 ]
  Change from baseline in Oxygenation index (PaO2 / FiO2 ratio) at every week
• 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 [ Time Frame: From baseline to Week 12 ]
  Perform chest X-ray or CT every week (W1 - W4) after screening, baseline, and W4 followed by 2 - week intervals (W6, W8). The investigator of each clinical trial organ shall check chest X-ray or CT for bilateral shading and evaluate them.
• SOFA score (Sequential Organ Failure Assessment) [ Time Frame: From baseline to Week 12 ]
  Check the SOFA score every week from the baseline to the W4 (W1 - W4) and 2 weeks after the W4 (W6, W8). The Sequential Organ Failure Assessment (SOFA) is a simple and clinically useful indicator that can be used to assess, predict, and monitor long-term failure in patients with multiple organ failure, and therefore increase in SOFA score can be expected to result in multiple organ failure and worse prognosis.
• 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 weekly intervals (W1 - W4) from baseline to baseline to W4 and 2 weeks after W4.
• Duration of total hospitalization and intensive care unit stay (days) [ Time Frame: From baseline to Week 12 ]
  Check hospitalization date, date of admission at intensive care unit, or discharge date and record them in eCRF.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Covid19 Pneumonia

Intervention

Drug: AstroStem-V

Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)

Study Arms

Experimental: AstroStem-V

AstroStem-V which consists of three syringes and each syringe contains 1.0 x 10^8 cells / 3mL of saline with 30% human serum

Intervention: Drug: AstroStem-V

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 24, 2020): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2023
• Estimated Primary Completion Date: November 1, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Hugh Lee; 301-540-260; hughlee@kcrnresearch.com

Contact: Jane Shin; 213-797-2655; jane.shin@stemcellbio.us

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04527224
• Other Study ID Numbers: ASVP1N2A-US
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Nature Cell Co. Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Nature Cell Co. Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: JeongChan Ra, Ph.D.; Nature Cell Co. Ltd.

• PRS Account: Nature Cell Co. Ltd.
• Verification Date: January 2023