ARDS, Human Clinical Trial
Official title:
Phase I/IIa Study to Assess AllogeneiC Expanded Human Mesenchymal Stem Cell Therapy in Patients Recovering From COVID-19 Acute Respiratory Distress Trial (ACE CARD TRIAL)
Allogeneic culture-expanded bone marrow-derived human mesenchymal stem cells (MSC) are the subject of the current study as they are supported by preclinical and clinical data for potential to provide a safe and effective treatment for patients with acute respiratory distress.
The majority of Covid-19 cases either are asymptomatic or result in only mild disease. However, in a substantial percentage of patients, a respiratory illness requiring hospital care develops, and such infections can progress to critical illness with hypoxemic respiratory failure requiring prolonged ventilatory support (Zhou 2020) , (Chen 2020) , (Cao 2020) , (Ruan 2020) . Among patients with Covid-19 who have been admitted to hospitals in the United Kingdom, the case fatality rate has been approximately 26%, a percentage that has increased to more than 37% among patients who were undergoing invasive mechanical ventilation.(Docherty 2020) Although remdesivir has been shown to shorten the time until recovery in hospitalized patients, (Beigel 2020). Efforts to modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death have shown promising results. INVESTIGATIONAL PRODUCT The NK1R+ MSC cell therapy are allogeneic bone marrow-derived mesenchymal stem cells that will be delivered intravenously. Details on cell culture and expansion of the cells are provided in the Chemistry Manufacturing and Controls Section of the IND. Cells are provided cryopreserved and are thawed, washed, and prepared for IV delivery. STUDY OBJECTIVES The objective of this clinical trial is to determine the safety and the optimal cell dose of the NK1R+ hMSC in patients recovering from ARDS. . ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06444750 -
Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers
|
||
| Not yet recruiting |
NCT05306392 -
Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation
|
N/A | |
| Terminated |
NCT04954014 -
Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients
|
Phase 2 | |
| Completed |
NCT04274296 -
Advisory Lead ARDS Respirator Management
|
||
| Completed |
NCT04719182 -
Practice of Adjunctive Treatments in Intensive Care Unit Patients With COVID-19
|
||
| Recruiting |
NCT03215316 -
Screening Expiratory Flow Limitation by Flow-time Curve
|
N/A | |
| Recruiting |
NCT04115514 -
Treatment of ARDS With Instilled T3
|
Phase 2 | |
| Not yet recruiting |
NCT05061212 -
The Mechanism of Extracellular Vesicles Containing Mitochondrial DNA in ARDS Lung Injury Caused by Extrapulmonary Sepsis
|
||
| Completed |
NCT05693051 -
Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO
|
||
| Not yet recruiting |
NCT04556864 -
Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to COVID-19
|
||
| Recruiting |
NCT04174014 -
Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography
|
N/A | |
| Enrolling by invitation |
NCT06164639 -
Potential Biomarkers for Reflux Aspiration-induced Lung Injury.
|
||
| Terminated |
NCT05384379 -
Efficacy and Safety Evaluation of BZ371B in ARDS Patients
|
Early Phase 1 | |
| Completed |
NCT04375735 -
London's Exogenous Surfactant Study for COVID19
|
Phase 1/Phase 2 | |
| Completed |
NCT06224010 -
Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS
|
||
| Not yet recruiting |
NCT04530188 -
Effects of Sevoflurane on Extravascular Lung Water and Pulmonary Vascular Permeability in Patients With ARDS
|
Phase 3 | |
| Completed |
NCT03405038 -
Prone Position Impact in ARDS Patients on the Incidence of Central Venous Catheter Colonization
|
||
| Recruiting |
NCT05148026 -
Regional Citrate Anticoagulation for RRT During V-V ECMO
|
N/A | |
| Recruiting |
NCT04390360 -
Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction
|
N/A | |
| Completed |
NCT06197256 -
Cardiac Dysfunction in Critically Ill Covid-19 Patients
|