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

NCT ID: NCT04452097

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2027-09-28

Brief Summary

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Human umbilical cord mesenchymal stem cells + best supportive care

Intervention Type: BIOLOGICAL

hUC-MSC product will be administered intravenously in addition to the standard of care treatment.

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.

Group Type: EXPERIMENTAL

Human umbilical cord mesenchymal stem cells + best supportive care

Intervention Type: BIOLOGICAL

hUC-MSC product will be administered intravenously in addition to the standard of care treatment.

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.

Group Type: EXPERIMENTAL

Human umbilical cord mesenchymal stem cells + best supportive care

Intervention Type: BIOLOGICAL

hUC-MSC product will be administered intravenously in addition to the standard of care treatment.

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.

Group Type: EXPERIMENTAL

Human umbilical cord mesenchymal stem cells + best supportive care

Intervention Type: BIOLOGICAL

hUC-MSC product will be administered intravenously in addition to the standard of care treatment.

Phase 2a Control Group

Eligible subjects will receive a single infusion of placebo control and standard of care treatment.

Group Type: PLACEBO_COMPARATOR

Placebo control + best supportive care

Intervention Type: OTHER

Placebo control will be administered intravenously in addition to the standard of care treatment.

Interventions

Human umbilical cord mesenchymal stem cells + best supportive care

hUC-MSC product will be administered intravenously in addition to the standard of care treatment.

Intervention Type: BIOLOGICAL

Placebo control + best supportive care

Placebo control will be administered intravenously in addition to the standard of care treatment.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylx Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BXU001-COVID19

Identifier Type: -

Identifier Source: org_study_id