Covid19 PneumoniaPhase 1/2NCT04527224
Study to Evaluate the Efficacy and Safety of AstroStem-V in Treatment of COVID-19 Pneumonia
A Phase 1/2 study testing AstroStem-V in people with Covid19 Pneumonia, run by Nature Cell Co. Ltd. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Covid19 Pneumonia
- What is being tested?
- AstroStem-V
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Oct 2022to 1 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Epic Medical Research
Dallas, Texas, 75154
Boghara Haresh, M.D.
- Recruiting
Medical Advancement Center of Arizona
Phoenix, Arizona, 85283
Enrique M. Cifuentes Jr., M.D.
About this study
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
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.
- Conditions
- Covid19 Pneumonia
- Being tested
- AstroStem-V
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstroStem-VDrug
Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)
| Study group | Role | What they receive |
|---|---|---|
| AstroStem-V | Experimental | AstroStem-V which consists of three syringes and each syringe contains 1.0 x 10^8 cells / 3mL of saline with 30% human serum Receives: Drug: AstroStem-V |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms.
Measured: From baseline to Week 12
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.
Measured: From baseline to Week 12
Secondary outcomes (6)
SpO2
Change from baseline in SpO2 at every visit
Measured: From baseline to Week 12
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.
Measured: Week 4, Week 8, and Week 12
Ventilator treatment status
Check the duration of the ventilator retention, check when the ventilator treatment has been completed after the baseline.
Measured: From Week 1 to Week 12
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.
Measured: From baseline to Week 12
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.
Measured: From baseline to Week 12
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.
Measured: From baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start24 Oct 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nature Cell Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JeongChan Ra, Ph.D., Study director, Nature Cell Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527224
- Sponsor's protocol ID
- ASVP1N2A-US
- Status last verified
- Jan 2023
- First submitted
- 21 Aug 2020
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04527224
- Acronym / sponsor ID
- ASVP1N2A-US
- Conditions
- Covid19 Pneumonia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nature Cell Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AstroStem-V | Experimental | Drug: AstroStem-VAstroStem-V which consists of three syringes and each syringe contains 1.0 x 10^8 cells / 3mL of saline with 30% human serum |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 voluntarily participate in the clinical trial with written informed consent
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AstroStem-VAllogenic adipose tissue-derived mesenchymal stem cells (AdMSCs) | Drug | AstroStem-V |
Primary outcome
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.
6 secondary outcomes
SpO2
Time frame: From baseline to Week 12
Mortality rate
Time frame: Week 4, Week 8, and Week 12
Ventilator treatment status
Time frame: 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
SOFA score (Sequential Organ Failure Assessment)
Time frame: From baseline to Week 12
2019 nCOV nucleic acid test
Time frame: From baseline to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JeongChan Ra, Ph.D. study director
Nature Cell Co. Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AstroStem-V in people with Covid19 Pneumonia, run by Nature Cell Co. Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hugh Lee (301-540-260, hughlee@kcrnresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: From baseline to Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.