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Mesenchymal stromal cellsWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug1158 IP-10 in CDS protocol Wiki 0.71
drug289 BI 1569912 Wiki 0.71
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (9)

Name (Synonyms) Correlation
D013577 Syndrome NIH 0.08
D055371 Acute Lung Injury NIH 0.07
D012127 Respiratory Distress Syndrome, Newborn NIH 0.07
D012128 Respiratory Distress Syndrome, Adult NIH 0.06
D003141 Communicable Diseases NIH 0.06
D011014 Pneumonia NIH 0.04
D007239 Infection NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.04
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.04

There are 2 clinical trials

Clinical Trials

1 Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.

NCT04445454 Coronavirus Infection Biological: Mesenchymal stromal cells
MeSH:Infection Communicable Diseases Coronavirus Infection Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: To assess the infusional toxicity

Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.

Measure: To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation

Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Description: Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)

Measure: To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

Time: Day 28

Secondary Outcomes

Description: To assess the clinical status (on a 7-point WHO ordinal scale)

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the duration of oxygen therapy and/or mechanical ventilation

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the length of stay at the intensive care unit and of hospitalization

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the number of organ failures

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the intensity of the inflammatory response

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the evolution of coagulation parameter

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the presence of Biomarker of lung lesion, repair and scarring

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 28

Description: To assess the v iral load over the 28 days after inclusion and seroconversion to COVID-19 over the 90 days after inclusion

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the pulmonary function

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Description: To assess the number of adverse reactions (ARs), ARs grade > 3, serious adverse events (SAEs), serious ARs (SARs), suspected expected and unexpected SARs (SESARs and SUSARs).

Measure: To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

Time: Day 90

Other Outcomes

Description: To determine the FACS analysis of regulatory T-cell (Treg) levels and Treg and Tconv sub-populations

Measure: To investigate immune modulation

Time: Day 28

Description: To assess the cytotoxic activity by MLR

Measure: To compare the cytotoxic activity of PBMCs from healthy control and COVID-19 patients (divided in responders / non-responders to MSC therapy) against MSCs in vitro

Time: Day 28

2 Multi-center, Randomized, Placebo Controlled, Interventional Phase 2A Clinical Trial Evaluating the Safety and Potential Efficacy of Multiple Dosing of Mesenchymal Stromal Cells in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2)

This is a multi-center, randomized, placebo controlled, interventional phase 2A trial to evaluate the safety profile and potential efficacy of multi-dosing of mesenchymal stromal cells (MSC) for patients with SARS-CoV-2 associated Acute Respiratory Distress Syndrome (ARDS). After informed consent, treatment assignment will be made by computer-generated randomization to administer either MSC or vehicle placebo control with a 2:1 allocation to the MSC: placebo arm.

NCT04466098 Acute Respiratory Distress Syndrome ARDS (Moderate or Severe) COVID-19 Pneumonia Biological: Mesenchymal stromal cells Other: Placebo
MeSH:Pneumonia Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acu Acute Lung Injury Syndrome
HPO:Pneumonia

Primary Outcomes

Measure: Incidence of grade 3-5 infusional toxicities and predefined hemodynamic or respiratory adverse events related to the infusion of MSC

Time: Within 6 hours of the start of the infusion

Secondary Outcomes

Measure: Incidence of a reduction in one or more biomarkers of inflammation by day 7

Time: Day 7 after first infusion

Measure: Trend changes in PaO2:FiO2 ratio

Time: On the day of screening and on days 3, 7 and 14 after first infusion

Measure: Trend changes in Mean Airway Pressure

Time: On the day of screening and on days 3, 7 and 14 after first infusion

Measure: Trend changes in peak pressure

Time: On the day of screening and on days 3, 7 and 14 after first infusion

Measure: Trend changes in plateau pressure

Time: On the day of screening (baseline) and on days 3, 7 and 14 after first infusion

Measure: Trend changes in Positive end-expiratory airway pressure (PEEP)

Time: On the day of screening and on days 3, 7 and 14 after first infusion

Measure: Incidence of mortality

Time: 28 days after first infusion

Measure: Incidence of mortality

Time: 100 days after first infusion

Measure: Number of ICU-free days

Time: 28 days after first infusion

Measure: Number of days alive and ventilator free composite score 3

Time: 28 days after first infusion

Description: Acute Lung Injury Score is a composite 4 point scoring system validated by the NHLBI ARDS Network that considers PaO2/FiO2, the level of positive end-expiratory airway pressure, respiratory compliance, and the extent of pulmonary infiltrates on the chest radiograph

Measure: Change in acute lung injury (ALI) score 2

Time: Baseline and Day 28 after first infusion

Measure: Incidence of serious adverse events

Time: 28 days after first infusion

Measure: Number of days alive off supplemental oxygen

Time: 100 days after first infusion

Related HPO nodes (Using clinical trials)

HP:0002090: Pneumonia
Genes 220
KMT2D OSTM1 GBA RSPH1 DOCK8 NKX2-1 RNU4ATAC SPAG1 RAG1 MCIDAS AFF4 TNFRSF13C DNAH1 NOTCH3 CD19 ALMS1 NADK2 UNC119 SFTPC FOXN1 CD79B CFAP221 CD81 SAMD9 MED25 ZAP70 RAG2 IGLL1 DNAAF1 RPGR STK36 LTBP3 PLOD1 DNAH9 BTK TERT COL11A2 OFD1 TNFRSF11A LRBA RSPH4A CD19 NME8 SMARCD2 GAS8 CFTR TNFRSF13B CCDC65 CFAP298 COL11A2 RAG1 ORC6 P4HTM MAN2B1 CFAP300 JAK3 CACNA1C ICOS SETBP1 TNFRSF13C SPEF2 LIG4 NIPBL STAT3 ZMYND10 IL7R MAN2B1 HLA-DQA1 IL21R SELENON SP110 ACADVL CCDC39 ARMC4 NSMCE3 NFIX DNAI2 ACP5 PTPRC ZAP70 KIAA0586 FCGR2A NFKB2 NEK10 MTHFD1 EGFR RYR1 ADA DNAI1 TGFB1 DNAAF6 IL2RG KCNJ6 DCLRE1C CCDC103 IGHM GNPTAB DNAAF4 PNP CFB DCLRE1C TAF1 CARD11 USB1 ADA ICOS FMO3 IL2RG HLA-DQB1 GFI1 SFTPA2 ICOS CD3D FOXJ1 CRLF1 ELANE IL2RG SRP54 NFKB1 PANK2 GAS2L2 CD247 IRF8 GAS8 RAG2 CCDC151 WAS ZBTB24 CD3E DNAL1 EXTL3 SLC35A1 NCF1 TK2 MS4A1 IFNGR1 RNF168 RMRP RSPH9 NHLRC1 MUC5B TNFRSF13C DNAH5 DNMT3B RNF125 EPM2A TTC12 JAK3 LEP RAC1 CYBA PGM3 NOS1 DDR2 AFF4 TBC1D24 CHD7 TNFRSF13B OFD1 DNAI1 RANBP2 TCIRG1 DNAJB13 CR2 CCDC40 IL2RG NCF2 RAG2 SLC25A24 SGCG WDR19 FOXP3 RNU4ATAC ACTA1 UBB CFAP410 BTK TTC25 CARD11 DNAAF2 CXCR4 MASP2 DRC1 TBCD DCLRE1C CYBB RSPH3 LRRC6 PIGN TNFSF12 DNAAF5 CCNO CSPP1 CR2 SLC35C1 HYDIN TIMM8A NBN NFKB2 CCDC114 CASP8 ADA IL7R CCDC114 TNFSF12 BTK LRRC56 PEPD BLNK CD55 GRHL3 NBN PRKCD KPTN PMM2 DNAAF3 KDM6A POLA1 RAG1 DNAH11
Protein Mutations 6
A2063G G551D K55R L460D R287Q S1009A
SNP 0