JadiCell for Acute Respiratory Distress Syndrome (ARDS) Treatment
This phase 3 study aims to evaluate the proportion of participants who are alive and free of respiratory failure following treatment with UC-MSC therapy for Acute Respiratory Distress Syndrome (ARDS).
Subjects in the UC-MSC treatment group will receive two intravenous infusions (at day 0 and 3) of 100 million UC-MSC.
+ Controls will receive two infusions of vehicle solution.
Inflammation+4
+ Lung Diseases
+ Pathologic Processes
Treatment Study
Summary
Study start date: July 1, 2026
Actual date on which the first participant was enrolled.Acute Respiratory Distress Syndrome (ARDS) is a serious condition where the lungs cannot provide enough oxygen, leading to high mortality rates. Current treatments mainly focus on supportive care, such as using a ventilator and managing intensive care. This study is exploring a new treatment called JadiCell™, which is derived from human umbilical cord tissue. JadiCell™ has properties that can help regulate the immune system and promote tissue repair, potentially reducing lung injury caused by inflammation. The study aims to help patients with ARDS by investigating if JadiCell™ can improve their condition. In this study, participants receive JadiCell™ through an intravenous administration, meaning it's given directly into a vein. The cells then travel to the lungs, where they interact with the immune system and damaged lung tissue. The main goal is to evaluate the safety of this treatment and its potential benefits. The study will measure the proportion of participants who are alive and no longer experiencing respiratory failure after receiving JadiCell™ therapy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.128 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Patients currently hospitalized 2. Laboratory confirmation of ARDS 3. Aged between 18 and 80 years 4. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent 5. SpO2 \<94% on room air requiring supplemental oxygen above baseline 6. PaO2/FiO2 \<300 mmHg 7. Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan 8. Requiring one of the following ï High Flow Oxygen Therapy ï Non-invasive Positive Pressure Ventilation (NIPPV, e.g. BiPAP and CPAP) ï Invasive Mechanical Ventilation (INV = intubated) Exclusion Criteria: 1. Greater than 96 h since hospitalization at the time of enrollment 2. Greater than 48 h since intubation at the time of enrollment 3. A previous MSC infusion not related to this trial 4. History of Pulmonary Hypertension (WHO Class III/IV) 5. History of left atrial hypertension or decompensated left heart failure. 6. Pregnant or lactating patient 7. Unstable arrhythmia 8. Patients currently receiving immunosuppression with exception of up to 10 mg Prednisone equivalents daily 9. Patients currently receiving chronic dialysis 10. Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO) 11. Presence of any active malignancy (except non-melanoma skin cancer) 12. Moderate to severe liver disease (AST and ALT \>5 X ULN) 13. Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or the use of home oxygen at rest 14. Septic Shock (with \>1 vasopressor) 15. Multi-organ failure 16. Not expected to survive \> 48 hours
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives