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AllogeneiC Expanded Human MSC Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial (ACE_CARD)

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ClinicalTrials.gov Identifier: NCT05491681
Recruitment Status : Not yet recruiting
First Posted : August 8, 2022
Last Update Posted : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
BioCardia, Inc.

Tracking Information
First Submitted Date  ICMJE August 5, 2022
First Posted Date  ICMJE August 8, 2022
Last Update Posted Date October 10, 2023
Estimated Study Start Date  ICMJE August 2024
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2022)
Number of product related adverse events through the duration of the study. [ Time Frame: 3 months ]
Number of product related adverse events through the duration of the study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2022)
Secondary Endpoint [ Time Frame: 12 months ]
Number of participants with resolution and/or improvement of ARDS at 7 days, 14 days, 21 days, and 28 days according to the Berlin Criteria.
  • Change in PF ratio from baseline to >200-300, and above >300
  • Absolute change in PF ratio
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AllogeneiC Expanded Human MSC Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial
Official Title  ICMJE Phase I/IIa Study to Assess AllogeneiC Expanded Human Mesenchymal Stem Cell Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial (ACE CARD TRIAL)
Brief Summary Allogeneic culture-expanded bone marrow-derived human mesenchymal stem cells (MSC) are the subject of the current study as they are supported by preclinical and clinical data for potential to provide a safe and effective treatment for patients with acute respiratory distress.
Detailed Description

The majority of Covid-19 cases either are asymptomatic or result in only mild disease. However, in a substantial percentage of patients, a respiratory illness requiring hospital care develops, and such infections can progress to critical illness with hypoxemic respiratory failure requiring prolonged ventilatory support (Zhou 2020) , (Chen 2020) , (Cao 2020) , (Ruan 2020) . Among patients with Covid-19 who have been admitted to hospitals in the United Kingdom, the case fatality rate has been approximately 26%, a percentage that has increased to more than 37% among patients who were undergoing invasive mechanical ventilation.(Docherty 2020) Although remdesivir has been shown to shorten the time until recovery in hospitalized patients, (Beigel 2020). Efforts to modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death have shown promising results.

INVESTIGATIONAL PRODUCT The NK1R+ MSC cell therapy are allogeneic bone marrow-derived mesenchymal stem cells that will be delivered intravenously.

Details on cell culture and expansion of the cells are provided in the Chemistry Manufacturing and Controls Section of the IND.

Cells are provided cryopreserved and are thawed, washed, and prepared for IV delivery.

STUDY OBJECTIVES The objective of this clinical trial is to determine the safety and the optimal cell dose of the NK1R+ hMSC in patients recovering from ARDS.

.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Dose finding study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE ARDS, Human
Intervention  ICMJE Biological: intravenous delivery of allogeneic bone marrow-derived MSCs
MSCs
Other Name: allogeneic NK1R+MSC
Study Arms  ICMJE
  • Experimental: Low dose
    Experimental: Cohort 1 Low dose, 20M cells, 3 patients
    Intervention: Biological: intravenous delivery of allogeneic bone marrow-derived MSCs
  • Experimental: Medium dose
    Experimental: Cohort 2 Med dose, 100M cells, 3 patients
    Intervention: Biological: intravenous delivery of allogeneic bone marrow-derived MSCs
  • Experimental: High dose
    Experimental: Cohort 3 High dose, 200M cells, 3 patients
    Intervention: Biological: intravenous delivery of allogeneic bone marrow-derived MSCs
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: August 5, 2022)
9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date August 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient > 18 years and ≤ 80 at age at consent
  2. Patient must have:

    • Have a laboratory-confirmed COVID-19 diagnosis (nucleic acid-based assay (e.g., RTPCR) to establish the diagnosis of SARS-CoV-2 infection), who recovered from moderate to severe COVID-19 associated ARDS, as determined by Berlin Criteria and been weaned off the ventilator support."
    • Meet the criteria for mild and moderate COVID-19 as described in COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry (Feb 2021).
    • Recovery from moderate to severe ARDS, diagnosed based on Berlin Criteria, within past 7 days.
  3. PaO2/FiO2 > 100 to <200 mmHg with PEEP>5cm H2O
  4. Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23
  5. Understands and agrees to comply with planned study procedures
  6. Available for clinical follow-up for duration of the treatment and follow-up period
  7. Woman of childbearing potential must have a negative pregnancy test at admission or within 24 hours before starting treatment
  8. Agree not to become pregnant during treatment and for 1 months after receiving treatment
  9. Use at least 2 reliable forms of effective contraception, including 1 barrier method, during treatment and for 1 month after the treatment period

Exclusion Criteria:

  1. Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen (chronic obstructive pulmonary disease or pulmonary fibrosis)
  2. Be an organ transplant recipient
  3. ALT/AST ≥ 5 times the upper limit of normal
  4. BMI > 40
  5. Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR <30)
  6. Anticipated transfer to another hospital that is not a study site within 72 hours
  7. Shock or on ECMO
  8. Pregnant or nursing
  9. On a ventilator at the time of enrollment
  10. Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for ≥14 consecutive days in the month prior to study entry.
  11. Have been diagnosed with cancer
  12. Demonstrated inability to comply with the study procedures
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: Patrick S Lee, MS 6505041915 plee@biocardia.com
Contact: Peter A Altman, PhD 6502554532 paltman@biocardia.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05491681
Other Study ID Numbers  ICMJE 05539-A
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party BioCardia, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BioCardia, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BioCardia, Inc.
Verification Date October 2023

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