- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04452097
Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS
August 9, 2022 updated by: Baylx Inc.
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
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
39
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vincent Liao, MD. Ph.D.
- Phone Number: 949-308-1952
- Email: baylx@baylxinc.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
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.
|
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.
|
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.
|
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.
|
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.
|
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
Time Frame: Day 3
|
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)
Time Frame: Day 28
|
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
Time Frame: Day 28
|
Day 28
|
|
Duration of hospital stay
Time Frame: Day 28
|
Day 28
|
|
Selection of an appropriate dose of BX-U001 for the following Phase 2 study
Time Frame: Day 28
|
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.
Time Frame: Day 14
|
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
Time Frame: Day 28
|
Day 28
|
|
Changes in blood cytokine levels
Time Frame: Day 28
|
Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2023
Primary Completion (ANTICIPATED)
March 31, 2024
Study Completion (ANTICIPATED)
May 31, 2024
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)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 9, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease
- Infant, Newborn, Diseases
- Lung Injury
- Infant, Premature, Diseases
- COVID-19
- Syndrome
- Respiratory Distress Syndrome
- Respiratory Distress Syndrome, Newborn
- Acute Lung Injury
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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