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

January 9, 2023 updated by: Nature Cell Co. Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85283
        • Recruiting
        • Medical Advancement Center of Arizona
        • Contact:
          • Enrique M. Cifuentes Jr., M.D.
    • Texas
      • Dallas, Texas, United States, 75154
        • Recruiting
        • Epic Medical Research
        • Contact:
          • Boghara Haresh, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to Week 12
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.
From baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SpO2
Time Frame: From baseline to Week 12
Change from baseline in SpO2 at every visit
From baseline to Week 12
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.
Week 4, Week 8, and Week 12
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.
From Week 1 to Week 12
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.
From baseline to Week 12
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.
From baseline to Week 12
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.
From baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nature Cell Co. Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASVP1N2A-US

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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