hCT-MSCs for COVID19 ARDS

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: COVID, Corona Virus Infection, COVID19

In brief

This is a 50 patient, Phase 1/2a multi-center pilot study to test the safety and to describe the preliminary efficacy of intravenous administration of allogenic human cord tissue mesenchymal stromal cells (hCT-MSC) as an investigational agent, under U.S. INDs 19968 (Duke) and 19937 (U Miami) to patients with acute respiratory distress syndrome (ARDS) due to COVID-19 infection (COVID-ARDS). The first 10 consecutive patients will receive investigational MSCs manufactured by Duke. In the second phase of the study, 40 additional patients will be randomized to receive placebo or investigational MSCs manufactured by Duke or University of Miami. Patients will be eligible for infusion of 3 daily consecutive doses of hCT-MSC or placebo if they have a confirmed diagnosis of COVID-19 and meet clinical and radiographic criteria for ARDS. Results from the first 10 patients will be compared with concurrent outcomes utilizing standard of care treatments in participating hospitals and in published reports in the medical literature. Results from the additional 40 patients will be combined with the first 10 and analyzed. The trial is relying on focused eligibility of the participants (patients with ARDS), single cohort with short trial time (4 weeks), and simple assessment of clinical outcome (survival, improvement of ARDS). This is a sequential design in the sense that after the first 10 patients are evaluated a decision will be made by the PIs and the Data Safety Monitoring Board whether to proceed with the exploratory randomized portion of the study.

Key facts

Study ID: NCT04399889
Run by: Joanne Kurtzberg, MD
People needed: 12
Starts: 2020-06-18
Expected to finish: 2022-02-16
Last updated by the study team: 2022-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

The patient or legally authorized representative (LAR) must have the ability to understand and the willingness to provide a signed and dated informed consent form.
Age 18 years and over
The patient agrees to use adequate contraception for the duration of the treatment protocol and for 6 months post treatment.
Positive RT- PCR testing for COVID-19 nucleic acid using nasopharyngeal swabbing or any other site
Patient meets ARDS criteria and is on non-invasive or mechanical ventilation or high flow nasal cannula
bilateral opacities on chest imaging consistent with pulmonary edema
A need for positive pressure ventilation or high flow nasal cannula
PaO2/FiO2 ratio ≤ 300 mmHg by arterial blood gas or SpO2/FiO2 imputation.
Infiltrates not fully explained by cardiac failure or fluid overload in the physician's best clinical judgement
Subjects requiring dialysis as a result of a COVID-19 infection will not be excluded.

You may not qualify if…

Evidence of multiorgan failure involving one or more organs, excluding the lungs as defined below:
Presence of shock, defined as MAP < 65 mmHg with signs of peripheral hypoperfusion, or continuous infusion of 2 or more vasopressor or inotrope agents to maintain MAP ≥ 65 mmHg.
Serum bilirubin > 10 mg/dl
Platelet count < 50,000/ml
Subjects requiring dialysis as a result of anything other than a COVID-19 infection will be excluded
Evidence of acquired or congenital immunodeficiency (due to immunosuppressive therapy excluding steroid use for treatment of COVID-19 acute respiratory failure, HIV, previous treatment for cancer, etc.)
History of metastatic cancer diagnosis or treatment in the past 1 year
History of previous treatments with MSCs or other cell therapies
Patient is co-enrolled in any other IND-sponsored clinical trials for COVID-19 or ARDs. Drugs that are administered under emergency use authorizations (EUA) by the FDA are permitted.
Evidence of pregnancy or lactation
Moribund patient not expected to survive >24 hours
Unable/unwilling to deliver lung protective ventilation
Patient is receiving Extracorporeal Membrane Oxygenation (ECMO)

Where it is running

Boca Raton Regional Hospital — Boca Raton, Florida, United States
Jackson Memorial Hospital — Miami, Florida, United States
University of Miami Hospital — Miami, Florida, United States
New York Medical College — Valhalla, New York, United States
Duke Hospital — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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