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

Primary Purpose

Covid19 Pneumonia

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AstroStem-V
Sponsored by
Nature Cell Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 Pneumonia

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Advancement Center of ArizonaRecruiting
  • Epic Medical ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AstroStem-V

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of adverse events
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
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

SpO2
Change from baseline in SpO2 at every visit
Mortality rate
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
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)
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)
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
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.

Full Information

First Posted
August 21, 2020
Last Updated
January 9, 2023
Sponsor
Nature Cell Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04527224
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nature Cell Co. Ltd.

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19 Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AstroStem-V
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
AstroStem-V
Intervention Description
Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms.
Time Frame
From baseline to Week 12
Title
Abnormalities of physical examination, vital signs, and laboratory test
Description
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.
Time Frame
From baseline to Week 12
Secondary Outcome Measure Information:
Title
SpO2
Description
Change from baseline in SpO2 at every visit
Time Frame
From baseline to Week 12
Title
Mortality rate
Description
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.
Time Frame
Week 4, Week 8, and Week 12
Title
Ventilator treatment status
Description
Check the duration of the ventilator retention, check when the ventilator treatment has been completed after the baseline.
Time Frame
From Week 1 to Week 12
Title
Improvement of pneumonia assessed by radiologic examination(Chest X-ray or CT)
Description
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.
Time Frame
From baseline to Week 12
Title
SOFA score (Sequential Organ Failure Assessment)
Description
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.
Time Frame
From baseline to Week 12
Title
2019 nCOV nucleic acid test
Description
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.
Time Frame
From baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hugh Lee
Phone
301-540-260
Email
hughlee@kcrnresearch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Shin
Phone
213-797-2655
Email
jane.shin@stemcellbio.us
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JeongChan Ra, Ph.D.
Organizational Affiliation
Nature Cell Co. Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Medical Advancement Center of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique M. Cifuentes Jr., M.D.
Facility Name
Epic Medical Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boghara Haresh, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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