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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452097
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
Baylx Inc.

Brief Summary:
This 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.

Condition or disease Intervention/treatment Phase
COVID-19 ARDS Acute Respiratory Distress Syndrome Biological: Human umbilical cord mesenchymal stem cells + best supportive care Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Eligible subjects will be divided into low, medium and high-dose groups with 3 patients/group. If there is no safety concerns for each group, the dose will be escalated from lower dose to the next higher dose.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of the Safety and Tolerability of BX-U001 for the Treatment of Severe COVID-19 Pneumonia With Moderate to Severe Acute Respiratory Distress Syndrome (ARDS).
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Experimental: 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: 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: 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.




Primary Outcome Measures :
  1. Incidence of infusion-related adverse events [ Time Frame: Day 3 ]
    Safety will be defined by the incidence of infusion-related adverse events as assessed by the treating physician

  2. Incidence of any treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) [ Time Frame: Day 28 ]
    Safety will be defined by the incidence of TEAEs and TESAEs as assessed by the treating physician


Secondary Outcome Measures :
  1. Selection of an appropriate dose of the hUC-MSC product for the following Phase 2 study [ Time Frame: Day 28 ]
    The dose will be selected based on the assessment of dose-limiting toxicity and maximum tolerated dose.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452097


Contacts
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Contact: Vincent Liao, MD. Ph.D. 949-308-1952 baylx@baylxinc.com

Sponsors and Collaborators
Baylx Inc.
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Responsible Party: Baylx Inc.
ClinicalTrials.gov Identifier: NCT04452097    
Other Study ID Numbers: BXU001-COVID19
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury