Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS

The Phase 1, open-label, non-controlled trial in this study will investigate the safety of intravenous (IV) infusion of ULSC in a total of 20 patients with COVID-19-related ARDS that will include patients that are not intubated and not on a ventilator (NV) and patients that are intubated and on a ventilator (V) for respiratory support. Separate cohorts of each group (NV and V) will receive either a single dose (one infusion) or repeat dose (two infusions separated by 48-hour interval).

The Phase 2a randomized and placebo-controlled trial in this study will investigate the potential efficacy of IV infusion of ULSC in a total of 40 patients with COVID-19-related ARDS that will all be EITHER NV or V; the determination of that eligibility criterion and the ULSC dosing regimen will be based on Phase 1 data of safety and tolerability. Phase 2a will evaluate EITHER single dose (one infusion) or repeat dose (two infusions separated by 48-hour interval). The randomization will be 3:1 with 30 patients receiving investigational product (ULSC) and 10 patients receiving placebo (carrier control).

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.