Safety, Tolerability, and Efficacy of MatriPlax in Subjects With Acute Respiratory Distress Syndrome

Exclusion Criteria

• •1. No intent/unwillingness to follow lung-protective ventilation strategy or fluid management manual
• •2. On extracorporeal membrane oxygenation (ECMO) support
• •3. Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or with any oxygen support
• •4. A subject who is extremely unlikely to survive more than 24 hours in the opinion of the investigator
• •5. World Health Organization (WHO) Class III or IV pulmonary hypertension
• •6. Clinical evidence of left ventricular failure
• •7. With acute diseases or serious medical conditions include cardiovascular (such as cardiac arrhythmia, QT prolongation), pulmonary (except ARDS), hepatic, neurologic, metabolic, renal, psychiatric condition, autoimmune disease, medical history, physical findings, or laboratory abnormality that in the investigators' opinion are not in stable condition and participating in the study could adversely affect the safety of the subject
• •8. Severe liver disease (Childs-Pugh Score \> 10)
• •9. Acute or chronic kidney disease (Stage-3B, 4 or 5 renal impair; estimated glomerular filtration rate (eGFR) ˂ 60 mL/min/1.73 m\^2 or dialysis)
• •Note: eGFR (mL/min/1.73 m\^2) = 186.3 × (serum creatinine in mg/dL)\^-1.154 × (age)\^-0.203× (0.742 if female) × (1.212 if African American/black)
• •10. History of pulmonary embolism
• •11. Previous solid organ transplant
• •12. With major surgery within 14 days prior to Screening visit Note: Major surgery is defined as an invasive operative procedure where one or more of the following occurred: 1) A body cavity was entered; 2) A mesenchymal barrier was crossed; 3) A fascial plane was opened; 4) An organ was removed; 5) Normal anatomy was operatively altered. All other invasive operative procedures are minor surgeries.
• •13. Presence of any active malignancy within 2 years prior to Screening visit
• •14. History of the human immunodeficiency virus (HIV) infection
• •15. History of severe allergic or anaphylactic reactions
• •16. Known or suspected hypersensitivity or previous adverse reaction to any ingredients of study product
• •17. Participation in a clinical trial of an interventional medicinal product within 12 weeks prior to Screening visit
• •18. With any other uncontrolled illness judged by the principal investigator that entering the trial may be detrimental to the subject
• •19. Pregnant or lactating or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period. At least one form of birth control must be adopted. Acceptable forms include:
• •* Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• •* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)
• •20. Female subject with childbearing potential who has positive serum or urine pregnancy test at Screening Visit
• •21. Unable to return for follow-up visits for clinical evaluation or laboratory studies
• •22. Inappropriate to participate in this clinical study because of psychiatric disorders or any condition as judged by the principal investigator
• •23. Hypersensitive to penicillin, streptomycin and amphotericin B antibiotics
• •24. With specific known risk factors for thrombotic events, including obesity (Body mass index (BMI) \>35), diabetes mellitus Type I, history of deep vein thrombosis (DVT) or thrombotic episodes, acquired or inherited thrombophilic disorders, hypercoagulable conditions, and other cardiovascular risk factors judged by the investigator
• •25. Use of estrogens/oral contraceptives within 6 weeks prior to Screening visit
• •26. Current smoker or has smoked within 3 months prior to Screening visit.