Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS
NCT ID: NCT04494386
Last Updated: 2024-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
17 participants
INTERVENTIONAL
2020-12-23
2023-05-12
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ULSC in Phase 1 Open Label
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.
Umbilical Cord Lining Stem Cells (ULSC)
IV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection
ULSC in Phase 2a Randomized
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.
Umbilical Cord Lining Stem Cells (ULSC)
IV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection
Placebo in Phase 2a Randomized
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.
Placebo (carrier control)
IV infusion of carrier control consisting of sterile saline for injection
Interventions
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Umbilical Cord Lining Stem Cells (ULSC)
IV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection
Placebo (carrier control)
IV infusion of carrier control consisting of sterile saline for injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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
4. Patient who has exhibited deterioration in condition during the past 72 hours prior to the informed consent.
5. Patient receiving standard of care in-hospital therapy, including appropriate critical oxygenation, fluid, and hemodynamic support as indicated clinically.
6. Patient or responsible family member or surrogate signs informed consent.
Exclusion Criteria
2. 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.
3. Organ transplant recipient.
4. Chronic renal failure being treated by renal replacement therapy (dialysis) before development of COVID-19.
5. Any other condition that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration, or follow-up.
6. 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.
18 Years
ALL
No
Sponsors
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Restem, LLC.
INDUSTRY
Responsible Party
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Locations
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Miami Baptist Hospital
Miami, Florida, United States
Sanford Research
Sioux Falls, South Dakota, United States
Countries
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Other Identifiers
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ULSC-CV-01
Identifier Type: -
Identifier Source: org_study_id
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