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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
Sponsor:
Information provided by (Responsible Party):
Nature Cell Co. Ltd.

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.

Condition or disease Intervention/treatment Phase
Covid19 Pneumonia Drug: AstroStem-V Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: AstroStem-V
Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. SpO2 [ Time Frame: From baseline to Week 12 ]
    Change from baseline in SpO2 at every visit

  2. 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.

  3. 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.

  4. 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.

  5. 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.


  6. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 14 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

Information from the National Library of Medicine

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


Contacts
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Contact: Hugh Lee 301-540-260 hughlee@kcrnresearch.com
Contact: Jane Shin 213-797-2655 jane.shin@stemcellbio.us

Locations
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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.         
Sponsors and Collaborators
Nature Cell Co. Ltd.
Investigators
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Study Director: JeongChan Ra, Ph.D. Nature Cell Co. Ltd.
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Responsible Party: Nature Cell Co. Ltd.
ClinicalTrials.gov Identifier: NCT04527224    
Other Study ID Numbers: ASVP1N2A-US
First Posted: August 26, 2020    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia
Respiratory Tract Infections
Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases