Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS (ULSC)
Covid19, Corona Virus Infection, SARS-CoV Infection
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- Adult, male or female, age ≥18 years old
- Diagnosis of the presence of the COVID-19 agent with confirmation of COVID-19 by standard reverse transcriptase polymerase chain reaction (RT-PCR) or equivalent test.
Patient with diagnosis of COVID-related ARDS, classified as either:
- Not requiring mechanical ventilation (NV) or
- Requiring mechanical ventilation (V).
According to Berlin Definition of Acute Respiratory Distress Syndrome (ARDS), patients will be categorized based on degrees of hypoxemia [arterial partial pressure of oxygen (PaO2)/oxygen concentration (FiO2)]:
- Mild ARDS: 200 mm Hg < PaO2/FIO2 ≤ 300 mm Hg
- Moderate ARDS: 100 mm Hg < PaO2/FIO2 ≤ 200 mm Hg
- Severe ARDS: PaO2/FIO2 ≤ 100 mm Hg
- Patient who has exhibited deterioration in condition during the past 72 hours prior to the informed consent.
- Patient receiving standard of care in-hospital therapy, including appropriate critical oxygenation, fluid, and hemodynamic support as indicated clinically.
- Patient or responsible family member or surrogate signs informed consent.
Exclusion Criteria
- Hypersensitivity to study product components. History of hypersensitivity to dimethyl sulfoxide (DMSO).
- Active cancer or prior diagnosis of cancer within the past year; however, patients with basal and squamous cell cancer of skin will not be excluded.
- Organ transplant recipient.
- Chronic renal failure being treated by renal replacement therapy (dialysis) before development of COVID-19.
- Any other condition that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration, or follow-up.
- Pregnancy or lactation; a negative pregnancy test between screening and day 1 (before administration of treatment) will be required of women with childbearing potential, and they will be advised of the requirement to use an effective means of contraception. A woman is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.
Sites / Locations
- Miami Baptist Hospital
- Sanford Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
ULSC in Phase 1 Open Label
ULSC in Phase 2a Randomized
Placebo in Phase 2a Randomized
Intravenous (IV) infusion of ULSC in 20 patients with COVID-19 ARDS: In Phase 1, two separate cohorts per group will receive either a single dose (one infusion) or repeat dose regimen (two infusions separated by 48-hour interval). The first cohort enrolled will receive the single dose; the next cohort enrolled will be administered the repeat dose regimen.
Intravenous (IV) infusion of ULSC in 30 patients with COVID-19 ARDS: In Phase 2a, 30 patients assigned ULSC will receive either a single dose (one infusion) or repeat dose regimen (two infusions separated by 48-hour interval). The ULSC dosing regimen will be chosen based on Phase 1 data of safety and tolerability.
Intravenous (IV) infusion of carrier control in 10 patients with COVID-19 ARDS: In Phase 2a, 10 patients assigned Placebo will receive either single dose (one infusion) or repeat dose (two infusions separated by 48-hour interval) of carrier control; the dosing regimen will correspond to that of the experimental arm.