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

COVID-19 Clinical Trial

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04452097
• Other study ID #: BXU001-COVID19
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2022
• Source: Baylx Inc.
• Contact: Vincent Liao, MD. Ph.D.
• Phone: 949-308-1952
• Email: baylx[@]baylxinc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: May 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• ARDS
• COVID-19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.

Other:
• Placebo control + best supportive care
Placebo control will be administered intravenously in addition to the standard of care treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylx Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	All-cause mortality		Day 28
Secondary	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
Secondary	Duration of ICU stay		Day 28
Secondary	Duration of hospital stay		Day 28
Secondary	Changes in blood cytokine levels		Day 28