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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 : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
Baylx Inc.

Tracking Information
First Submitted Date  ICMJE June 28, 2020
First Posted Date  ICMJE June 30, 2020
Last Update Posted Date November 27, 2020
Estimated Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2020)
  • Selection of an appropriate dose of BX-U001 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.
  • All-cause mortality [ Time Frame: Day 28 ]
  • Proportion of patients achieving clinical response by the improvement of at least 2 points on the 7-point ordinal scale. [ Time Frame: 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 [ Time Frame: Day 28 ]
  • Duration of hospital stay [ Time Frame: Day 28 ]
  • Changes in blood cytokine levels [ Time Frame: Day 28 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2020)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS
Official Title  ICMJE A Phase 1/2a Study of the Safety and Efficacy of BX-U001 for the Treatment of Severe COVID-19 Pneumonia With Moderate to Severe Acute Respiratory Distress Syndrome (ARDS).
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 0.5×10^6, 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
In phase 1, 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. In phase 2a, a total of 30 subjects will be randomized into the treatment and control groups with a ratio of 3:2.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • COVID-19
  • ARDS
  • Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • 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.
  • Other: Placebo control + best supportive care
    Placebo control will be administered intravenously in addition to the standard of care treatment.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Human umbilical cord mesenchymal stem cells + best supportive care
  • 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.
    Intervention: Biological: Human umbilical cord mesenchymal stem cells + best supportive care
  • 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.
    Intervention: Biological: Human umbilical cord mesenchymal stem cells + best supportive care
  • 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.
    Intervention: Biological: Human umbilical cord mesenchymal stem cells + best supportive care
  • Placebo Comparator: Phase 2a Control Group
    Eligible subjects will receive a single infusion of placebo control and standard of care treatment.
    Intervention: Other: Placebo control + best supportive care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2020)
39
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2020)
9
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vincent Liao, MD. Ph.D. 949-308-1952 baylx@baylxinc.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452097
Other Study ID Numbers  ICMJE BXU001-COVID19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baylx Inc.
Study Sponsor  ICMJE Baylx Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Baylx Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP