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

Primary Purpose

COVID-19, ARDS, Acute Respiratory Distress Syndrome

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Human umbilical cord mesenchymal stem cells + best supportive care

Placebo control + best supportive care

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Phase 1 Low-dose Group

Phase 1 Middle-dose Group

Phase 1 High-dose Group

Phase 2a Treatment Group

Phase 2a Control Group

Arm Description

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.

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.

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.

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.

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

Outcomes

Primary Outcome Measures

Incidence of infusion-related adverse events

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)

Safety will be defined by the incidence of TEAEs and TESAEs as assessed by the treating physician

Secondary Outcome Measures

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.

All-cause mortality

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.

Duration of ICU stay

Duration of hospital stay

Changes in blood cytokine levels

Full Information

NCT ID

NCT04452097

First Posted

June 28, 2020

Last Updated

August 9, 2022

Sponsor

Baylx Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04452097

Brief Title

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

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).

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2023 (Anticipated)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baylx Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, ARDS, Acute Respiratory Distress Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

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)

Allocation

Non-Randomized

Enrollment

39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase 1 Low-dose Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Phase 1 Middle-dose Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Phase 1 High-dose Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Phase 2a Treatment Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Phase 2a Control Group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Human umbilical cord mesenchymal stem cells + best supportive care

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo control + best supportive care

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of infusion-related adverse events

Description

Safety will be defined by the incidence of infusion-related adverse events as assessed by the treating physician

Time Frame

Day 3

Title

Incidence of any treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)

Description

Safety will be defined by the incidence of TEAEs and TESAEs as assessed by the treating physician

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

Selection of an appropriate dose of BX-U001 for the following Phase 2 study

Description

The dose will be selected based on the assessment of dose-limiting toxicity and maximum tolerated dose.

Time Frame

Day 28

Title

All-cause mortality

Time Frame

Day 28

Title

Proportion of patients achieving clinical response by the improvement of at least 2 points on the 7-point ordinal scale.

Description

Time Frame

Day 14

Title

Duration of ICU stay

Time Frame

Day 28

Title

Duration of hospital stay

Time Frame

Day 28

Title

Changes in blood cytokine levels

Time Frame

Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vincent Liao, MD. Ph.D.

Phone

949-308-1952

baylx@baylxinc.com

12. IPD Sharing Statement

Learn more about this trial

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

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