Status:
COMPLETED
Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS
Lead Sponsor:
Restem, LLC.
Conditions:
Covid19
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 L...
Detailed Description
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 pati...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04494386
Start Date
December 23 2020
End Date
May 12 2023
Last Update
April 9 2024
Active Locations (2)
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1
Miami Baptist Hospital
Miami, Florida, United States, 33176
2
Sanford Research
Sioux Falls, South Dakota, United States, 57105