ARDS, HumanPhase 1ACE_CARDNCT05491681
AllogeneiC Expanded Human MSC Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial
A Phase 1 study testing intravenous delivery of allogeneic bone marrow-derived MSCs in people with ARDS, Human, run by BioCardia, Inc..
Trial summary
Allogeneic culture-expanded bone marrow-derived human mesenchymal stem cells (MSC) are the subject of the current study as they are supported by preclinical and clinical data for potential to provide a safe and effective treatment for patients with acute respiratory distress. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS, Human
- What is being tested?
- intravenous delivery of allogeneic bone marrow-derived MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2026to 4 Jan 2026
- Phase
- Phase 1
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient > 18 years and ≤ 80 at age at consent
- Patient must have:
- Have a laboratory-confirmed COVID-19 diagnosis (nucleic acid-based assay (e.g., RTPCR) to establish the diagnosis of SARS-CoV-2 infection), who recovered from moderate to severe COVID-19 associated ARDS, as determined by Berlin Criteria and been weaned off the ventilator support."
- Meet the criteria for mild and moderate COVID-19 as described in COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry (Feb 2021).
- Recovery from moderate to severe ARDS, diagnosed based on Berlin Criteria, within past 7 days.
- PaO2/FiO2 > 100 to <200 mmHg with PEEP>5cm H2O
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- Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23
- Understands and agrees to comply with planned study procedures
- Available for clinical follow-up for duration of the treatment and follow-up period
- Woman of childbearing potential must have a negative pregnancy test at admission or within 24 hours before starting treatment
- Agree not to become pregnant during treatment and for 1 months after receiving treatment
- Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period
Who cannot join
- Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen (chronic obstructive pulmonary disease or pulmonary fibrosis)
- Be an organ transplant recipient
- ALT/AST ≥ 5 times the upper limit of normal
- BMI > 40
- Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR <30)
- Anticipated transfer to another hospital that is not a study site within 72 hours
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- Shock or on ECMO
- Pregnant or nursing
- On a ventilator at the time of enrollment
- Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for ≥14 consecutive days in the month prior to study entry.
- Have been diagnosed with cancer
- Demonstrated inability to comply with the study procedures
About this study
Official title: Phase I/IIa Study to Assess AllogeneiC Expanded Human Mesenchymal Stem Cell Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial (ACE CARD TRIAL)
Allogeneic culture-expanded bone marrow-derived human mesenchymal stem cells (MSC) are the subject of the current study as they are supported by preclinical and clinical data for potential to provide a safe and effective treatment for patients with acute respiratory distress.
Read the detailed description
The majority of Covid-19 cases either are asymptomatic or result in only mild disease. However, in a substantial percentage of patients, a respiratory illness requiring hospital care develops, and such infections can progress to critical illness with hypoxemic respiratory failure requiring prolonged ventilatory support (Zhou 2020) , (Chen 2020) , (Cao 2020) , (Ruan 2020) . Among patients with Covid-19 who have been admitted to hospitals in the United Kingdom, the case fatality rate has been approximately 26%, a percentage that has increased to more than 37% among patients who were undergoing invasive mechanical ventilation.(Docherty 2020) Although remdesivir has been shown to shorten the time until recovery in hospitalized patients, (Beigel 2020). Efforts to modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death have shown promising results.
INVESTIGATIONAL PRODUCT The NK1R+ MSC cell therapy are allogeneic bone marrow-derived mesenchymal stem cells that will be delivered intravenously.
Details on cell culture and expansion of the cells are provided in the Chemistry Manufacturing and Controls Section of the IND.
Cells are provided cryopreserved and are thawed, washed, and prepared for IV delivery.
STUDY OBJECTIVES The objective of this clinical trial is to determine the safety and the optimal cell dose of the NK1R+ hMSC in patients recovering from ARDS.
.
- Conditions
- ARDS, Human
- Being tested
- intravenous delivery of allogeneic bone marrow-derived MSCs
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous delivery of allogeneic bone marrow-derived MSCsBiological
Also called allogeneic NK1R+MSC
MSCs
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Experimental: Cohort 1 Low dose, 20M cells, 3 patients Receives: Biological: intravenous delivery of allogeneic bone marrow-derived MSCs |
| Medium dose | Experimental | Experimental: Cohort 2 Med dose, 100M cells, 3 patients Receives: Biological: intravenous delivery of allogeneic bone marrow-derived MSCs |
| High dose | Experimental | Experimental: Cohort 3 High dose, 200M cells, 3 patients Receives: Biological: intravenous delivery of allogeneic bone marrow-derived MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of product related adverse events through the duration of the study.
Number of product related adverse events through the duration of the study.
Measured: 3 months
Secondary outcomes (1)
Secondary Endpoint
Number of participants with resolution and/or improvement of ARDS at 7 days, 14 days, 21 days, and 28 days according to the Berlin Criteria.
- Change in PF ratio from baseline to >200-300, and above >300
- Absolute change in PF ratio
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start4 Jan 2026
- Primary completion4 Jan 2026
- Study completion4 Jan 2026
Why it stopped: With available funding it was necessary for Sponsor to prioritize other studies. No study participants were consented or enrolled and no study sites were activated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose finding study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCardia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491681
- Sponsor's protocol ID
- 05539-A
- Acronym
- ACE_CARD
- Status last verified
- Jan 2026
- First submitted
- 5 Aug 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Study to Assess AllogeneiC Expanded Human Mesenchymal Stem Cell Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial (ACE CARD TRIAL)
- ClinicalTrials.gov ID
- NCT05491681
- Acronym / sponsor ID
- ACE_CARD / 05539-A
- Conditions
- ARDS, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: With available funding it was necessary for Sponsor to prioritize other studies. No study participants were consented or enrolled and no study sites were activated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BioCardia, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- 4 Jan 2026 (actual)
- Study completion
- 4 Jan 2026 (actual)
- First posted
- 8 Aug 2022 (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.
Allogeneic culture-expanded bone marrow-derived human mesenchymal stem cells (MSC) are the subject of the current study as they are supported by preclinical and clinical data for potential to provide a safe and effective treatment for patients with acute respiratory distress.
Detailed description
The majority of Covid-19 cases either are asymptomatic or result in only mild disease. However, in a substantial percentage of patients, a respiratory illness requiring hospital care develops, and such infections can progress to critical illness with hypoxemic respiratory failure requiring prolonged ventilatory support (Zhou 2020) , (Chen 2020) , (Cao 2020) , (Ruan 2020) . Among patients with Covid-19 who have been admitted to hospitals in the United Kingdom, the case fatality rate has been approximately 26%, a percentage that has increased to more than 37% among patients who were undergoing invasive mechanical ventilation.(Docherty 2020) Although remdesivir has been shown to shorten the time until recovery in hospitalized patients, (Beigel 2020). Efforts to modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death have shown promising results.
INVESTIGATIONAL PRODUCT The NK1R+ MSC cell therapy are allogeneic bone marrow-derived mesenchymal stem cells that will be delivered intravenously.
Details on cell culture and expansion of the cells are provided in the Chemistry Manufacturing and Controls Section of the IND.
Cells are provided cryopreserved and are thawed, washed, and prepared for IV delivery.
STUDY OBJECTIVES The objective of this clinical trial is to determine the safety and the optimal cell dose of the NK1R+ hMSC in patients recovering from ARDS.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Dose finding study
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Biological: intravenous delivery of allogeneic bone marrow-derived MSCsExperimental: Cohort 1 Low dose, 20M cells, 3 patients |
| Medium dose | Experimental | Biological: intravenous delivery of allogeneic bone marrow-derived MSCsExperimental: Cohort 2 Med dose, 100M cells, 3 patients |
| High dose | Experimental | Biological: intravenous delivery of allogeneic bone marrow-derived MSCsExperimental: Cohort 3 High dose, 200M cells, 3 patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient > 18 years and ≤ 80 at age at consent
- Patient must have:
- PaO2/FiO2 > 100 to <200 mmHg with PEEP>5cm H2O
- Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23
- Understands and agrees to comply with planned study procedures
Key exclusion criteria (12 listed)
- Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen (chronic obstructive pulmonary disease or pulmonary fibrosis)
- Be an organ transplant recipient
- ALT/AST ≥ 5 times the upper limit of normal
- BMI > 40
- Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR <30)
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 |
|---|---|---|
| intravenous delivery of allogeneic bone marrow-derived MSCsAlso: allogeneic NK1R+MSCMSCs | Biological | High dose, Low dose, Medium dose |
Primary outcome
Number of product related adverse events through the duration of the study.
Time frame: 3 months
Number of product related adverse events through the duration of the study.
1 secondary outcome
Secondary Endpoint
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing intravenous delivery of allogeneic bone marrow-derived MSCs in people with ARDS, Human, run by BioCardia, Inc..
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 12 inclusion and 12 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: withdrawn, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of product related adverse events through the duration of the study. (time frame: 3 months). 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 7 Jan 2026.