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Remestemcel-LWiki

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


Correlated Drug Terms (10)

Name (Synonyms) Correlation
drug2053 Regadenoson myocardial perfusion imaging stress test Wiki 0.58
drug2559 Treadmill electrocardiographic stress test Wiki 0.58
drug668 Coronary artery calcium score and cardiac computed tomographic angiography Wiki 0.58
drug773 Diphenhydramine Wiki 0.58
drug198 Antioxidation Therapy Wiki 0.58
drug211 Arm exercise electrocardiographic stress test Wiki 0.58
drug2938 other Wiki 0.41
drug1083 Hydrocortisone Wiki 0.29
drug2319 Standard of Care Wiki 0.11
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (5)

Name (Synonyms) Correlation
D013577 Syndrome NIH 0.19
D055371 Acute Lung Injury NIH 0.11
D012127 Respiratory Distress Syndrome, Newborn NIH 0.11
D012128 Respiratory Distress Syndrome, Adult NIH 0.10
D018352 Coronavirus Infections NIH 0.02

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 3 clinical trials

Clinical Trials

1 Intermediate-size Expanded Access of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells for Acute Respiratory Distress Syndrome Due to COVID-19 Infection

The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with ARDS due to coronavirus infection 2019 (COVID-19).

NCT04366830 Moderate to Severe Acute Respiratory Distress Syndrome Associated With COVID-19 Drug: Remestemcel-L
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

2 Mesenchymal Stem Cells for the Treatment of Moderate to Severe COVID-19 Acute Respiratory Distress Syndrome

The mortality rate in SARS-CoV-2-related severe ARDS is high despite treatment with antivirals, glucocorticoids, immunoglobulins, and ventilation. Preclinical and clinical evidence indicate that MSCs migrate to the lung and respond to the pro-inflammatory lung environment by releasing anti-inflammatory factors reducing the proliferation of pro-inflammatory cytokines while modulating regulatory T cells and macrophages to promote resolution of inflammation. Therefore, MSCs may have the potential to increase survival in management of COVID-19 induced ARDS. The primary objective of this phase 3 trial is to evaluate the efficacy and safety of the addition of the mesenchymal stromal cell (MSC) remestemcel-L plus standard of care compared to placebo plus standard of care in patients with acute respiratory distress syndrome (ARDS) due to SARS-CoV-2. The secondary objective is to assess the impact of MSCs on inflammatory biomarkers.

NCT04371393 Mesenchymal Stromal Cells Remestemcel-L Acute Respiratory Distress Syndrome COVID Biological: Remestemcel-L Drug: Placebo
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

Primary Outcomes

Description: Number of all-cause mortality within 30 days of randomization.

Measure: Number of all-cause mortality

Time: 30 days

Secondary Outcomes

Description: Number of days alive off mechanical ventilatory support calculated as the number of days, within the 60 days window, that patients were alive and free of mechanical ventilatory support.

Measure: Number of days alive off mechanical ventilatory support

Time: 60 days

Description: Safety analyses will be assessed by adverse event rates calculated as the ratio of the total number of events over 30 days divided by total patient-time at risk for the specific event from randomization.

Measure: Number of adverse events

Time: 30 days

Measure: Number of participants alive at day 7

Time: 7 days

Measure: Number of participants alive at day 14

Time: 14 days

Measure: Number of participants alive at day 60

Time: 60 days

Measure: Number of participants alive at day 90

Time: 90 days

Description: The number and percent of patients with resolution and/or improvement of ARDS at day 7

Measure: Number of participants with resolution and/or improvement of ARDS

Time: 7 days

Description: The number and percent of patients with resolution and/or improvement of ARDS at day 14

Measure: Number of participants with resolution and/or improvement of ARDS

Time: 14 days

Description: The number and percent of patients with resolution and/or improvement of ARDS at day 21

Measure: Number of participants with resolution and/or improvement of ARDS

Time: 21 days

Description: The number and percent of patients with resolution and/or improvement of ARDS at day 30

Measure: Number of participants with resolution and/or improvement of ARDS

Time: 30 days

Description: Change from baseline of the severity of ARDS according to Berlin Criteria at days 7 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.

Measure: Change from baseline of the severity of ARDS

Time: baseline and 7 days

Description: Change from baseline of the severity of ARDS according to Berlin Criteria at days 14 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.

Measure: Change from baseline of the severity of ARDS

Time: baseline and 14 days

Description: Change from baseline of the severity of ARDS according to Berlin Criteria at days 21 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.

Measure: Change from baseline of the severity of ARDS

Time: baseline and 21 days

Description: Change from baseline of the severity of ARDS according to Berlin Criteria at days 30 post-randomization Change from baseline of the severity of ARDS according to Berlin Criteria at days 7, 14, 21 and 30 post-randomization will be compared between treatment groups using a Cochran-Mantel-Haenszel test stratified by baseline severity.

Measure: Change from baseline of the severity of ARDS

Time: baseline and 30 days

Description: Hospital length of stay

Measure: Length of stay

Time: 12 months

Description: Change from baseline in Clinical Improvement Scale at day 7. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.

Measure: Clinical Improvement Scale

Time: 7 days

Description: Change from baseline in Clinical Improvement Scale at day 14. Full scale from 1 to 7, with higher score indicating more clinical improvement.

Measure: Clinical Improvement Scale

Time: 14 days

Description: Change from baseline in Clinical Improvement Scale at day 21. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.

Measure: Clinical Improvement Scale

Time: 21 days

Description: Change from baseline in Clinical Improvement Scale at day 30. Clinical Improvement Scale full scale from 1 to 7, with higher score indicating more clinical improvement.

Measure: Clinical Improvement Scale

Time: 30 days

Description: Changes from baseline in serum hs-CRP concentration at days 7

Measure: Change in serum hs-CRP concentration

Time: baseline and 7 days

Description: Changes from baseline in serum hs-CRP concentration at days 14

Measure: Change in serum hs-CRP concentration

Time: baseline and 14 days

Description: Changes from baseline in serum hs-CRP concentration at days 21

Measure: Change in serum hs-CRP concentration

Time: baseline and 21 days

Description: Changes from baseline in serum hs-CRP concentration at days 30

Measure: Change in serum hs-CRP concentration

Time: baseline and 30 days

Description: Changes from baseline in IL-6 inflammatory marker level at 7 days

Measure: Change in IL-6 inflammatory marker level

Time: baseline and 7 days

Description: Changes from baseline in IL-6 inflammatory marker level at 14 days

Measure: Change in IL-6 inflammatory marker level

Time: baseline and 14 days

Description: Changes from baseline in IL-6 inflammatory marker level at 21 days

Measure: Change in IL-6 inflammatory marker level

Time: baseline and 21 days

Description: Changes from baseline in IL-6 inflammatory marker level at 30 days

Measure: Change in IL-6 inflammatory marker level

Time: baseline and 30 days

Description: Changes from baseline in IL-6 inflammatory marker level at 7 days

Measure: Change in IL-8 inflammatory marker level

Time: baseline and 7 days

Description: Changes from baseline in IL-6 inflammatory marker level at 14 days

Measure: Change in IL-8 inflammatory marker level

Time: baseline and 14 days

Description: Changes from baseline in IL-6 inflammatory marker level at 21 days

Measure: Change in IL-8 inflammatory marker level

Time: baseline and 21 days

Description: Changes from baseline in IL-6 inflammatory marker level at 30 days

Measure: Change in IL-8 inflammatory marker level

Time: baseline and 30 days

Description: Changes from baseline in TNF-alpha inflammatory marker level at 7 days

Measure: Change in TNF-alpha inflammatory marker level

Time: baseline and 7 days

Description: Changes from baseline in TNF-alpha inflammatory marker level at 14 days

Measure: Change in TNF-alpha inflammatory marker level

Time: baseline and 14 days

Description: Changes from baseline in TNF-alpha inflammatory marker level at 21 days

Measure: Change in TNF-alpha inflammatory marker level

Time: baseline and 21 days

Description: Changes from baseline in TNF-alpha inflammatory marker level at 30 days

Measure: Change in TNF-alpha inflammatory marker level

Time: baseline and 30 days

3 Intermediate-size Expanded Access of Remestemcel-L, Human Mesenchymal Stromal Cells, for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19)

The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with MIS-C associated with COVID-19.

NCT04456439 Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19) Biological: Remestemcel-L Drug: Hydrocortisone Drug: Diphenhydramine
MeSH:Coronavirus Infections Syndrome


No related HPO nodes (Using clinical trials)