This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: 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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
ARDS, Human Biological: intravenous delivery of allogeneic bone marrow-derived MSCs Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose finding study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : August 2024
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Low dose
Experimental: Cohort 1 Low dose, 20M cells, 3 patients
 Biological: intravenous delivery of allogeneic bone marrow-derived MSCs
MSCs
Other Name: allogeneic NK1R+MSC
Experimental: Medium dose
Experimental: Cohort 2 Med dose, 100M cells, 3 patients
 Biological: intravenous delivery of allogeneic bone marrow-derived MSCs
MSCs
Other Name: allogeneic NK1R+MSC
Experimental: High dose
Experimental: Cohort 3 High dose, 200M cells, 3 patients
 Biological: intravenous delivery of allogeneic bone marrow-derived MSCs
MSCs
Other Name: allogeneic NK1R+MSC


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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. 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05491681


Contacts
Layout table for location contacts
Contact: Patrick S Lee, MS 6505041915 plee@biocardia.com
Contact: Peter A Altman, PhD 6502554532 paltman@biocardia.com

Sponsors and Collaborators
BioCardia, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: BioCardia, Inc.
ClinicalTrials.gov Identifier: NCT05491681    
Other Study ID Numbers: 05539-A
First Posted: August 8, 2022    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders