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

Baylx

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: COVID-19; Acute Respiratory Distress Syndrome; ARDS

Treatments: Biological: Human umbilical cord mesenchymal stem cells + best supportive care; Other: Placebo control + best supportive care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04452097

BXU001-COVID19

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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0 participants in 5 patient groups, including a placebo group

Phase 1 Low-dose Group

Experimental group

Description:

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.

Treatment:

Biological: Human umbilical cord mesenchymal stem cells + best supportive care

Phase 1 Middle-dose Group

Experimental group

Description:

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.

Treatment:

Biological: Human umbilical cord mesenchymal stem cells + best supportive care

Phase 1 High-dose Group

Experimental group

Description:

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.

Treatment:

Biological: Human umbilical cord mesenchymal stem cells + best supportive care

Phase 2a Treatment Group

Experimental group

Description:

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.

Treatment:

Biological: Human umbilical cord mesenchymal stem cells + best supportive care

Phase 2a Control Group

Placebo Comparator group

Description:

Eligible subjects will receive a single infusion of placebo control and standard of care treatment.

Treatment:

Other: Placebo control + best supportive care