Status:
WITHDRAWN
Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS
Lead Sponsor:
Baylx Inc.
Conditions:
COVID-19
ARDS
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04452097
Start Date
June 1 2026
End Date
September 28 2027
Last Update
December 29 2025
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