Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS (NCT04494386) | Clinical Trial Compass
CompletedPhase 1/2
Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS
United States17 participantsStarted 2020-12-23
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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:
✓. 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.
What they're measuring
1
Incidence of Dose Limiting Toxicity (DLT)
Timeframe: 24 hours
2
Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE)
Timeframe: 1 week
3
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
Timeframe: 1 month
4
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
. 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.