Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS (NCT04452097) | Clinical Trial Compass
WithdrawnPhase 1/2
Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS
Stopped: It is a strategic decision by the company, coupled with low incidence of ARDS cases following widespread vaccination efforts.
0Started 2026-06-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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;
✕
What they're measuring
1
Incidence of infusion-related adverse events
Timeframe: Day 3
2
Incidence of any treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
. 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;