COVID-19Phase 1/2NCT04452097

Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS

A Phase 1/2 study of COVID-19 and ARDS, run by Baylx Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: COVID-19, ARDS, Acute Respiratory Distress Syndrome
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: 1 Jun 2026to 28 Sep 2027
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, aged between 18 and 80;
Laboratory (RT-PCR, Gene Sequencing or Antibody) confirmed cases of severe COVID-19 pneumonia with mild to moderate ARDS (Berlin definition);
Patients are intubated;
Patients who voluntarily adhere to the research procedures and ensure good compliance during the research period;
Patients who fully understand the research nature of this study and sign written informed consent.

Who cannot join

Subjects who have received investigational drug (except for Remdesivir) for the treatment of COVID-19 within 30 days before screening;
Subjects who are pregnant, breastfeeding or whose urinary pregnancy test is positive before participation in the study; subjects who are pregnant, breastfeeding, have a birth plan, or are unwillingness to use contraception during the study period and within 12 months of infusion; except for subjects who have sterilization surgery or menopause during the study period;
Within 3 days before screening/randomization, subjects who have used high-dose corticosteroids that is equivalent to methylprednisolone >240 mg/day or irregular use of systemic corticosteroids to treat other diseases that could affect the efficacy evaluated by the investigator;
Subjects receiving extracorporeal membrane oxygenation (ECMO) support.
Subjects who are allergic to low-molecular-weight heparin calcium or human albumin;
Subjects with ongoing malignant tumors.

About this study

Official title: A Phase 1/2a Study of the Safety and Efficacy of BX-U001 for the Treatment of Severe COVID-19 Pneumonia With Moderate to Severe Acute Respiratory Distress Syndrome (ARDS).

This is a phase 1/2a study including 2 parts, phase 1 and phase 2a. The phase 1 part is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acute respiratory distress syndrome (ARDS). Qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of BX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight, respectively. The Phase 2a part is a randomized, placebo-controlled, double-blind clinical trial examining the safety and biological effects of BX-U001 at the appropriate dose selected from phase 1 for severe COVID-19 pneumonia patients with the same inclusion/exclusion criteria as the phase 1 part.

Conditions: COVID-19, ARDS, Acute Respiratory Distress Syndrome
Being tested: Human umbilical cord mesenchymal stem cells + best supportive care, Placebo control + best supportive care
Medical subject headings: COVID-19, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Human umbilical cord mesenchymal stem cells + best supportive careBiological
hUC-MSC product will be administered intravenously in addition to the standard of care treatment.
Placebo control + best supportive careOther
Placebo control will be administered intravenously in addition to the standard of care treatment.

Study groups in NCT04452097
Study group	Role	What they receive
Phase 1 Low-dose Group	Experimental	Eligible subjects will receive a single infusion of hUC-MCS product at the dose of 0.5 million cells/kg in addition to standard of care treatment. Receives: Biological: Human umbilical cord mesenchymal stem cells + best supportive care
Phase 1 Middle-dose Group	Experimental	Eligible subjects will receive a single infusion of hUC-MCS product at the dose of 1 million cells/kg in addition to standard of care treatment. Receives: Biological: Human umbilical cord mesenchymal stem cells + best supportive care
Phase 1 High-dose Group	Experimental	Eligible subjects will receive a single infusion of hUC-MCS product at the dose of 1.5 million cells/kg in addition to standard of care treatment. Receives: Biological: Human umbilical cord mesenchymal stem cells + best supportive care
Phase 2a Treatment Group	Experimental	Eligible subjects will receive a single infusion of hUC-MCS product at the selected dose from phase 1 in addition to standard of care treatment. Receives: Biological: Human umbilical cord mesenchymal stem cells + best supportive care
Phase 2a Control Group	Placebo comparator	Eligible subjects will receive a single infusion of placebo control and standard of care treatment. Receives: Other: Placebo control + best supportive care

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of infusion-related adverse events
Safety will be defined by the incidence of infusion-related adverse events as assessed by the treating physician
Measured: Day 3
Incidence of any treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Safety will be defined by the incidence of TEAEs and TESAEs as assessed by the treating physician
Measured: Day 28

Secondary outcomes (6)

Selection of an appropriate dose of BX-U001 for the following Phase 2 study
The dose will be selected based on the assessment of dose-limiting toxicity and maximum tolerated dose.
Measured: Day 28
All-cause mortality
Measured: Day 28
Proportion of patients achieving clinical response by the improvement of at least 2 points on the 7-point ordinal scale.
The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care 7. Not hospitalized.
Measured: Day 14
Duration of ICU stay
Measured: Day 28
Duration of hospital stay
Measured: Day 28
Changes in blood cytokine levels
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202628 Sep 2027

First posted30 Jun 2020
Study start1 Jun 2026 (estimated)
Primary completion1 Jul 2027 (estimated)
Study completion28 Sep 2027 (estimated)

Why it stopped: It is a strategic decision by the company, coupled with low incidence of ARDS cases following widespread vaccination efforts.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies 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: Non-randomised
Intervention model: Sequential
Model description: In phase 1, eligible subjects will be divided into low, medium and high-dose groups with 3 patients/group. If there is no safety concerns for each group, the dose will be escalated from lower dose to the next higher dose. In phase 2a, a total of 30 subjects will be randomized into the treatment and control groups with a ratio of 3:2.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04452097
Sponsor's protocol ID: BXU001-COVID19
Status last verified: Dec 2025
First submitted: 28 Jun 2020
Last updated: 29 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a Study of the Safety and Efficacy of BX-U001 for the Treatment of Severe COVID-19 Pneumonia With Moderate to Severe Acute Respiratory Distress Syndrome (ARDS).
ClinicalTrials.gov ID: NCT04452097
Acronym / sponsor ID: BXU001-COVID19
Conditions: COVID-19, ARDS, Acute Respiratory Distress Syndrome
Phase: Phase 1/2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: It is a strategic decision by the company, coupled with low incidence of ARDS cases following widespread vaccination efforts.
Enrolment: 0 participants (actual)
Lead sponsor: Baylx Inc.Industry (pharma, biotech, devices)
Study start: 1 Jun 2026 (estimated)
Primary completion: 1 Jul 2027 (estimated)
Study completion: 28 Sep 2027 (estimated)
First posted: 30 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 5
Model description: In phase 1, eligible subjects will be divided into low, medium and high-dose groups with 3 patients/group. If there is no safety concerns for each group, the dose will be escalated from lower dose to the next higher dose. In phase 2a, a total of 30 subjects will be randomized into the treatment and control groups with a ratio of 3:2.

Arm	Type	Receives
Phase 1 Low-dose Group	Experimental	Biological: Human umbilical cord mesenchymal stem cells + best supportive careEligible subjects will receive a single infusion of hUC-MCS product at the dose of 0.5 million cells/kg in addition to standard of care treatment.
Phase 1 Middle-dose Group	Experimental	Biological: Human umbilical cord mesenchymal stem cells + best supportive careEligible subjects will receive a single infusion of hUC-MCS product at the dose of 1 million cells/kg in addition to standard of care treatment.
Phase 1 High-dose Group	Experimental	Biological: Human umbilical cord mesenchymal stem cells + best supportive careEligible subjects will receive a single infusion of hUC-MCS product at the dose of 1.5 million cells/kg in addition to standard of care treatment.
Phase 2a Treatment Group	Experimental	Biological: Human umbilical cord mesenchymal stem cells + best supportive careEligible subjects will receive a single infusion of hUC-MCS product at the selected dose from phase 1 in addition to standard of care treatment.
Phase 2a Control Group	Placebo comparator	Other: Placebo control + best supportive careEligible subjects will receive a single infusion of placebo control and standard of care treatment.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female, aged between 18 and 80;
Laboratory (RT-PCR, Gene Sequencing or Antibody) confirmed cases of severe COVID-19 pneumonia with mild to moderate ARDS (Berlin definition);
Patients are intubated;
Patients who voluntarily adhere to the research procedures and ensure good compliance during the research period;
Patients who fully understand the research nature of this study and sign written informed consent.

Key exclusion criteria (6 listed)

Subjects who have received investigational drug (except for Remdesivir) for the treatment of COVID-19 within 30 days before screening;
Subjects who are pregnant, breastfeeding or whose urinary pregnancy test is positive before participation in the study; subjects who are pregnant, breastfeeding, have a birth plan, or are unwillingness to use contraception during the study period and within 12 months of infusion; except for subjects who have sterilization surgery or menopause during the study period;
Within 3 days before screening/randomization, subjects who have used high-dose corticosteroids that is equivalent to methylprednisolone >240 mg/day or irregular use of systemic corticosteroids to treat other diseases that could affect the efficacy evaluated by the investigator;
Subjects receiving extracorporeal membrane oxygenation (ECMO) support.
Subjects who are allergic to low-molecular-weight heparin calcium or human albumin;

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
Human umbilical cord mesenchymal stem cells + best supportive carehUC-MSC product will be administered intravenously in addition to the standard of care treatment.	Biological	Phase 1 High-dose Group, Phase 1 Low-dose Group, Phase 1 Middle-dose Group, Phase 2a Treatment Group
Placebo control + best supportive carePlacebo control will be administered intravenously in addition to the standard of care treatment.	Other	Phase 2a Control Group

Primary outcome

Incidence of infusion-related adverse events
Time frame: Day 3
Safety will be defined by the incidence of infusion-related adverse events as assessed by the treating physician
Incidence of any treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Time frame: Day 28
Safety will be defined by the incidence of TEAEs and TESAEs as assessed by the treating physician

6 secondary outcomes

Selection of an appropriate dose of BX-U001 for the following Phase 2 study
Time frame: Day 28
All-cause mortality
Time frame: Day 28
Proportion of patients achieving clinical response by the improvement of at least 2 points on the 7-point ordinal scale.
Time frame: Day 14
Duration of ICU stay
Time frame: Day 28
Duration of hospital stay
Time frame: Day 28
Changes in blood cytokine levels
Time frame: Day 28

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 29 Dec 2025.

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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 1/2 study of COVID-19 and ARDS, run by Baylx 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 5 inclusion and 6 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 29 Dec 2025. 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. Some participants in this study may receive a placebo. 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?

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?

Incidence of infusion-related adverse events (time frame: Day 3). 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?

On the ClinicalTrials.gov record for NCT04452097.

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 29 Dec 2025.