CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Human umbilical cord mesenchymal stem cells + best supportive careWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug284 BCG Vaccine Wiki 0.58
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D013577 Syndrome NIH 0.11
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.10
D012128 Respiratory Distress Syndrome, Adult NIH 0.09

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase 1 Study of the Safety and Tolerability of BX-U001 for the Treatment of Severe COVID-19 Pneumonia With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS).

This is an open-label, single-arm, dose-escalating study to evaluate the safety and explore the dose limiting toxicity and maximum tolerated dose of a human umbilical cord derived mesenchymal stem cell product (BX-U001) in severe COVID-19 pneumonia patients with acute respiratory distress syndrome (ARDS). Qualified subjects after the screening will be divided into low, medium, or high dose groups to receive a single intravenous infusion of BX-U001 at the dose of 0.5×10^6, 1.0×10^6, or 1.5×10^6 cells/kg of body weight, respectively.

NCT04452097 COVID-19 ARDS Acute Respiratory Distress Syndrome Biological: Human umbilical cord mesenchymal stem cells + best supportive care
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Safety will be defined by the incidence of infusion-related adverse events as assessed by the treating physician

Measure: Incidence of infusion-related adverse events

Time: Day 3

Description: Safety will be defined by the incidence of TEAEs and TESAEs as assessed by the treating physician

Measure: Incidence of any treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)

Time: Day 28

Secondary Outcomes

Description: The dose will be selected based on the assessment of dose-limiting toxicity and maximum tolerated dose.

Measure: Selection of an appropriate dose of the hUC-MSC product for the following Phase 2 study

Time: Day 28

No related HPO nodes (Using clinical trials)