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

Primary Purpose

ARDS, Human

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

intravenous delivery of allogeneic bone marrow-derived MSCs

About this trial

This is an interventional treatment trial for ARDS, Human

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient > 18 years and ≤ 80 at age at consent
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.
PaO2/FiO2 > 100 to <200 mmHg with PEEP>5cm H2O
Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23
Understands and agrees to comply with planned study procedures
Available for clinical follow-up for duration of the treatment and follow-up period
Woman of childbearing potential must have a negative pregnancy test at admission or within 24 hours before starting treatment
Agree not to become pregnant during treatment and for 1 months after receiving treatment
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:

Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen (chronic obstructive pulmonary disease or pulmonary fibrosis)
Be an organ transplant recipient
ALT/AST ≥ 5 times the upper limit of normal
BMI > 40
Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR <30)
Anticipated transfer to another hospital that is not a study site within 72 hours
Shock or on ECMO
Pregnant or nursing
On a ventilator at the time of enrollment
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.
Have been diagnosed with cancer
Demonstrated inability to comply with the study procedures

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Low dose

Medium dose

High dose

Arm Description

Experimental: Cohort 1 Low dose, 20M cells, 3 patients

Experimental: Cohort 2 Med dose, 100M cells, 3 patients

Experimental: Cohort 3 High dose, 200M cells, 3 patients

Outcomes

Primary Outcome Measures

Number of product related adverse events through the duration of the study.

Secondary Outcome Measures

Secondary Endpoint

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

Full Information

NCT ID

NCT05491681

First Posted

August 5, 2022

Last Updated

October 5, 2023

Sponsor

BioCardia, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05491681

Brief Title

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

Acronym

ACE_CARD

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 2024 (Anticipated)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioCardia, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ARDS, Human

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Dose finding study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low dose

Arm Type

Experimental

Arm Description

Experimental: Cohort 1 Low dose, 20M cells, 3 patients

Arm Title

Medium dose

Arm Type

Experimental

Arm Description

Experimental: Cohort 2 Med dose, 100M cells, 3 patients

Arm Title

High dose

Arm Type

Experimental

Arm Description

Experimental: Cohort 3 High dose, 200M cells, 3 patients

Intervention Type

Biological

Intervention Name(s)

intravenous delivery of allogeneic bone marrow-derived MSCs

Other Intervention Name(s)

allogeneic NK1R+MSC

Intervention Description

MSCs

Primary Outcome Measure Information:

Title

Number of product related adverse events through the duration of the study.

Description

Number of product related adverse events through the duration of the study.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Secondary Endpoint

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient > 18 years and ≤ 80 at age at consent 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. PaO2/FiO2 > 100 to <200 mmHg with PEEP>5cm H2O Patient or legally authorized representative (LAR) provides written informed consent, except as noted in 21 CFR 50.23 Understands and agrees to comply with planned study procedures Available for clinical follow-up for duration of the treatment and follow-up period Woman of childbearing potential must have a negative pregnancy test at admission or within 24 hours before starting treatment Agree not to become pregnant during treatment and for 1 months after receiving treatment 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: Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen (chronic obstructive pulmonary disease or pulmonary fibrosis) Be an organ transplant recipient ALT/AST ≥ 5 times the upper limit of normal BMI > 40 Stage 4 severe kidney disease or requiring dialysis (i.e. eGFR <30) Anticipated transfer to another hospital that is not a study site within 72 hours Shock or on ECMO Pregnant or nursing On a ventilator at the time of enrollment 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. Have been diagnosed with cancer Demonstrated inability to comply with the study procedures

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick S Lee, MS

Phone

6505041915

plee@biocardia.com

First Name & Middle Initial & Last Name or Official Title & Degree

Peter A Altman, PhD

Phone

6502554532

paltman@biocardia.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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