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

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.

Study Overview

• Status: Withdrawn
• Conditions: COVID-19; Acute Respiratory Distress Syndrome; ARDS
• Intervention / Treatment: Biological: Human umbilical cord mesenchymal stem cells + best supportive care; Other: Placebo control + best supportive care

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects who have received investigational drug (except for Remdesivir) for the treatment of COVID-19 within 30 days before screening;
2. 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;
3. 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;
4. Subjects receiving extracorporeal membrane oxygenation (ECMO) support.
5. Subjects who are allergic to low-molecular-weight heparin calcium or human albumin;
6. Subjects with ongoing malignant tumors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1 Low-dose Group; 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.	Biological: Human umbilical cord mesenchymal stem cells + best supportive care; hUC-MSC product will be administered intravenously in addition to the standard of care treatment.
Experimental: Phase 1 Middle-dose Group; 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.	Biological: Human umbilical cord mesenchymal stem cells + best supportive care; hUC-MSC product will be administered intravenously in addition to the standard of care treatment.
Experimental: Phase 1 High-dose Group; 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.	Biological: Human umbilical cord mesenchymal stem cells + best supportive care; hUC-MSC product will be administered intravenously in addition to the standard of care treatment.
Experimental: Phase 2a Treatment Group; 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.	Biological: Human umbilical cord mesenchymal stem cells + best supportive care; hUC-MSC product will be administered intravenously in addition to the standard of care treatment.
Placebo Comparator: Phase 2a Control Group; Eligible subjects will receive a single infusion of placebo control and standard of care treatment.	Other: Placebo control + best supportive care; Placebo control will be administered intravenously in addition to the standard of care treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of infusion-related adverse events	Safety will be defined by the incidence of infusion-related adverse events as assessed by the treating physician	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	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		Day 28
Duration of hospital stay		Day 28
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.	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.	Day 14
Duration of ICU stay		Day 28
Changes in blood cytokine levels		Day 28

Collaborators and Investigators

• Sponsor: Baylx Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 28, 2027

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Respiratory Distress Syndrome
• Other Study ID Numbers: BXU001-COVID19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No