ULSC-CV-01 is a clinical trial that comprises both Phase 1 and Phase 2a, which will be conducted sequentially. This trial will evaluate the safety and potential efficacy of allogeneic Umbilical Cord Lining Stem Cells (ULSC), which are a type of umbilical cord tissue derived mesenchymal stem cells (MSC), with intravenous (IV) administration in hospitalized patients with acute respiratory distress syndrome (ARDS) due to COVID-19.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
17
IV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection
IV infusion of carrier control consisting of sterile saline for injection
Miami Baptist Hospital
Miami, Florida, United States
Sanford Research
Sioux Falls, South Dakota, United States
Incidence of Dose Limiting Toxicity (DLT)
Number of subjects with a DLT event during or within 24 hours after ULSC infusion \[Dose Limiting Toxicities are treatment-emergent suspected adverse reactions graded as severe, such as severe infusion-related hypersensitivity toxicities of grade ≥3, and any treatment-emergent serious adverse event (SAE) will be investigated to determine if DLT.\]
Time frame: 24 hours
Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE)
Number of subjects with a DLT event, suspected adverse reaction, or any serious adverse event (SAE) within 1 week of each ULSC infusion
Time frame: 1 week
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study up to 1-month follow-up
Time frame: 1 month
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
Treatment-emergent adverse events (AE; incidence, grade, and assessment of relatedness or causality) and serious adverse events (SAE) during the study and up to the 12-month follow-up
Time frame: 12 months
Levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS
Times to transitions between levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS
Time frame: 1 month
Changes from baseline pulse oximetric saturation SpO2/FiO2 ratio or arterial oxygen pressure pAO2/FiO2 ratio
Changes in SpO2/FiO2 ratio or pAO2/FiO2 ratio compared to baseline, measured daily at a minimum; oxygenation index daily when on ventilator
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Time frame: 1 month
Number of ventilator-free days (VFD)
Number of ventilator-free days (VFD) in period of 1 month from study treatment
Time frame: 1 month
Changes in Complete Blood Count (CBC) with differential from baseline
Changes in CBC with differential from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of blood glucose (mg/dL) from baseline
Changes in blood glucose (mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of sodium (mEq/L) from baseline
Changes in levels of sodium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of potassium (mEq/L) from baseline
Changes in levels of potassium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline
Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Changes in levels of alanine transaminase (ALT; U/L) from baseline
Changes in levels of alanine transaminase (ALT; U/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
Time frame: 1 month, 2 months, 3 months, 6 months, and 12 months
Change in Urinalysis (UA) from baseline
Change in Urinalysis (UA) at baseline and 1 month after study treatment to assess for presence and qualitative proteinuria
Time frame: 1 month