Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-24 @ 9:39 PM
NCT ID:
NCT05238532
Eligibility Criteria:
Inclusion Criteria:
* ≥ 19 years old
* Patients who meet the ARDS criteria according to the Berline definition
1. within 1 week of a known clinical insult or new or worsening respiratory symtoms
2. Bilateral opacities not fully explained by effusions, loar/lung collapse, or nodules
3. Respiratory failure not fully explained by cardiac failure or fluid overload
4. oxygenation corresponding to mild, moderate, severe
* Patients requiring positive pressure ventilation using an endotracheal tube
* Patients or legal representative signed Informed consent form
Exclusion Criteria:
* Greater than 96 hours since first meeting ARDS criteria
* Patients who was previously administered mesenchymal stem cell therapy products or other cell therapy products
* Patients with the following medical history or comorbid condition
1. medical history
1. Patients who had an organ transplant or bone-marrow transplantation
2. Patients who had a pneumonectomy
3. a maligant tumor within 5 years
4. a deep vein thrombosis or pulmonary embolism with in 6 months
5. a trauma within 7 days
2. comorbid condition
1. Patients with AST or ALT exceeding 5 times the upper limit of the normal range
2. eGFR ≤ 29mL/min or Patients requiring continuous renal replacement therapy
3. severe chronic respiratory disease
4. WHO functional assessment class III/IV pulmonary hypertension
5. Severe cardiac insufficiency
6. QTc \> 480msec
7. chronic underlying diseases
* viral hepatitis type B or type C, or positive HIV test
* Patients using extracorporeal life support devices or high-frequency oscillatory ventilation
* Moribund patients expected to die within 48 hours
* Patients who refuse or are likely to refuse life-sustaining treatment
* Fertile women or men who disagree a continence and a contraception
* Patients with a history of hypersensitivity reaction
* Patients participating in clinical trials within 4 weeks
* Patients determined by the investigator to be inappropriate to participate in this clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT05238532
Study Brief:
Protocol Section:
NCT05238532