Mesenchymal Stem Cells for The Treatment of Acute Respiratory Distress Syndrome (ARDS)

Inclusion Criteria:

• Subjects of age ≥ 20 years and ≤ 85 years.

• Subject has a diagnosis of moderate ARDS according to the Berlin definition of ARDS:

  1. No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
  2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph.
  3. Hypoxemia: PaO2/ FiO2 > 100 mmHg to ≤ 200 mmHg with PEEP ≥ 5 cm H2O.
  4. The time of onset of ARDS is when all of the specified ARDS criteria (2a-c) are met.
• Patient is intubated and mechanically ventilated.
• Subjects who had an onset of ARDS within 72 to 120 hours before start of treatment.
• Subjects with body weight between 40 to 90 kg.
• No decompensated heart failure.
• Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.

• Women of child-bearing potential should have a negative serum pregnancy test prior to administration of investigational product., UNLESS they meet the following criteria:

  1. Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40 mIU/ml, OR;
  2. 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy.

Exclusion Criteria:

• Greater than 72 hours since first meeting ARDS criteria per the Berlin definition.
• No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol.
• Expected life < 3 months from other cause than the respiratory failure.
• Subject is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support.
• Subjects with history of any type of malignancy.
• Major trauma in the prior 5 days.
• Subjects with major surgery (body organs that require anesthesia, such as tumor removal, open chest, heart surgery, abdominal surgery, intracranial surgery, or normal surgery for more than 3 hours, etc.) within previous 14 days.
• Subjects who are pregnant (or plan to become pregnant within 3 months of investigational product treatment) or lactating.
• Subjects who have a significant concomitant illness as judged by principal investigator (PI).

• Subjects who have significant abnormal laboratory tests at screening:

  1. >5 × upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST).
  2. >3 × upper limit of normal for total bilirubin.
  3. >2 × upper limit of normal for serum creatinine.
• Subjects with known human immunodeficiency virus infection or who are immune compromised.
• Subjects who are unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation.
• Subjects with a history of severe allergic or anaphylactic reactions.
• Subjects with known allergy or hypersensitivity to any component of the formulation (normal saline and human serum albumin).
• Subjects who have participated in another clinical study of new investigational therapies or have received an investigational therapy within the 12 weeks before study drug administration.