Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS
Study Details
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 0.5×106, 1.0×106, 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Incidence of infusion-related adverse events [Day 3]
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) [Day 28]
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 [Day 28]
The dose will be selected based on the assessment of dose-limiting toxicity and maximum tolerated dose.
- All-cause mortality [Day 28]
- Proportion of patients achieving clinical response by the improvement of at least 2 points on the 7-point ordinal scale. [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.
- Duration of ICU stay [Day 28]
- Duration of hospital stay [Day 28]
- Changes in blood cytokine levels [Day 28]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, aged between 18 and 80;
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Laboratory (RT-PCR, Gene Sequencing or Antibody) confirmed cases of severe COVID-19 pneumonia with mild to moderate ARDS (Berlin definition);
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Patients are intubated;
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Patients who voluntarily adhere to the research procedures and ensure good compliance during the research period;
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Patients who fully understand the research nature of this study and sign written informed consent.
Exclusion Criteria:
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Subjects who have received investigational drug (except for Remdesivir) for the treatment of COVID-19 within 30 days before screening;
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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;
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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;
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Subjects receiving extracorporeal membrane oxygenation (ECMO) support.
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Subjects who are allergic to low-molecular-weight heparin calcium or human albumin;
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Subjects with ongoing malignant tumors.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Baylx Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BXU001-COVID19