- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04494386
Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS (ULSC)
Phase 1/2a Study of Umbilical Cord Lining Stem Cells (ULSC) in Patients With ARDS Due to COVID-19
Study Overview
Status
Intervention / Treatment
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 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
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
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Miami, Florida, United States, 33176
- Miami Baptist Hospital
-
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Sanford Research
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
IV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection
Other Names:
|
Experimental: 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. |
IV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection
Other Names:
|
Placebo Comparator: 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. |
IV infusion of carrier control consisting of sterile saline for injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Dose Limiting Toxicity (DLT)
Time Frame: 24 hours
|
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.] |
24 hours
|
Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE)
Time Frame: 1 week
|
Number of subjects with a DLT event, suspected adverse reaction, or any serious adverse event (SAE) within 1 week of each ULSC infusion
|
1 week
|
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
Time Frame: 1 month
|
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
|
1 month
|
Treatment-emergent adverse events (AE) and serious adverse events (SAE)
Time Frame: 12 months
|
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
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS
Time Frame: 1 month
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Times to transitions between levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS
|
1 month
|
Changes from baseline pulse oximetric saturation SpO2/FiO2 ratio or arterial oxygen pressure pAO2/FiO2 ratio
Time Frame: 1 month
|
Changes in SpO2/FiO2 ratio or pAO2/FiO2 ratio compared to baseline, measured daily at a minimum; oxygenation index daily when on ventilator
|
1 month
|
Number of ventilator-free days (VFD)
Time Frame: 1 month
|
Number of ventilator-free days (VFD) in period of 1 month from study treatment
|
1 month
|
Changes in Complete Blood Count (CBC) with differential from baseline
Time Frame: 1 month, 2 months, 3 months, 6 months, and 12 months
|
Changes in CBC with differential from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
|
1 month, 2 months, 3 months, 6 months, and 12 months
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Changes in levels of blood glucose (mg/dL) from baseline
Time Frame: 1 month, 2 months, 3 months, 6 months, and 12 months
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Changes in blood glucose (mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
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1 month, 2 months, 3 months, 6 months, and 12 months
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Changes in levels of sodium (mEq/L) from baseline
Time Frame: 1 month, 2 months, 3 months, 6 months, and 12 months
|
Changes in levels of sodium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
|
1 month, 2 months, 3 months, 6 months, and 12 months
|
Changes in levels of potassium (mEq/L) from baseline
Time Frame: 1 month, 2 months, 3 months, 6 months, and 12 months
|
Changes in levels of potassium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
|
1 month, 2 months, 3 months, 6 months, and 12 months
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Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline
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 to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment
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1 month, 2 months, 3 months, 6 months, and 12 months
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Changes in levels of alanine transaminase (ALT; U/L) from baseline
Time Frame: 1 month, 2 months, 3 months, 6 months, and 12 months
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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
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1 month, 2 months, 3 months, 6 months, and 12 months
|
Change in Urinalysis (UA) from baseline
Time Frame: 1 month
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Change in Urinalysis (UA) at baseline and 1 month after study treatment to assess for presence and qualitative proteinuria
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Severe Acute Respiratory Syndrome
- COVID-19
- Coronavirus Infections
- Infections
- Communicable Diseases
Other Study ID Numbers
- ULSC-CV-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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