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Umbilical Cord Lining Stem Cells (ULSC)Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug2126 Placebo (carrier control) Wiki 1.00
drug1376 Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki 1.00

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D003141 Communicable Diseases NIH 0.08
D007239 Infection NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Phase 1/2a Study of Umbilical Cord Lining Stem Cells (ULSC) in Patients With ARDS Due to COVID-19

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.

NCT04494386 Covid19 Corona Virus Infection SARS-CoV Infection ARDS Coronavirus Biological: Umbilical Cord Lining Stem Cells (ULSC) Other: Placebo (carrier control)
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: 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.]

Measure: Incidence of Dose Limiting Toxicity (DLT)

Time: 24 hours

Description: Number of subjects with a DLT event, suspected adverse reaction, or any serious adverse event (SAE) within 1 week of each ULSC infusion

Measure: Incidence of Dose Limiting Toxicity (DLT), suspected adverse reaction (SAR), or serious adverse event (SAE)

Time: 1 week

Description: 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

Measure: Treatment-emergent adverse events (AE) and serious adverse events (SAE)

Time: 1 month

Description: 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

Measure: Treatment-emergent adverse events (AE) and serious adverse events (SAE)

Time: 12 months

Secondary Outcomes

Description: Times to transitions between levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS

Measure: Levels of COVID-19 related ARDS as defined by the Berlin Definition of ARDS

Time: 1 month

Description: Changes in SpO2/FiO2 ratio or pAO2/FiO2 ratio compared to baseline, measured daily at a minimum; oxygenation index daily when on ventilator

Measure: Changes from baseline pulse oximetric saturation SpO2/FiO2 ratio or arterial oxygen pressure pAO2/FiO2 ratio

Time: 1 month

Description: Number of ventilator-free days (VFD) in period of 1 month from study treatment

Measure: Number of ventilator-free days (VFD)

Time: 1 month

Description: Changes in CBC with differential from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in Complete Blood Count (CBC) with differential from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in blood glucose (mg/dL) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of blood glucose (mg/dL) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in levels of sodium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of sodium (mEq/L) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Changes in levels of potassium (mEq/L) from baseline to 1 month, 2 months, 3 months, 6 months, and 12 months after study treatment

Measure: Changes in levels of potassium (mEq/L) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: 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

Measure: Changes in levels of blood urea nitrogen (BUN; mg/dL) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: 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

Measure: Changes in levels of alanine transaminase (ALT; U/L) from baseline

Time: 1 month, 2 months, 3 months, 6 months, and 12 months

Description: Change in Urinalysis (UA) at baseline and 1 month after study treatment to assess for presence and qualitative proteinuria

Measure: Change in Urinalysis (UA) from baseline

Time: 1 month

No related HPO nodes (Using clinical trials)