CompletedPhase 1/2

A Clinical Study of Mesenchymal Stem Cell Exosomes Nebulizer for the Treatment of ARDS

China18 participantsStarted 2020-11-30

Plain-language summary

To evaluate allogeneic human mesenchymal stem cell exosomes (hMSC-Exos) in the treatment of acute respiratory distress syndrome (ARDS)

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The subjects themselves or their family members voluntarily participate in this study and sign the informed consent form;
✓. 18-70 years old, male or female;
✓. Definitely diagnosed as acute respiratory distress syndrome (ARDS) (according to the Berlin definition and diagnostic criteria of ARDS);
✓. Course of disease \<96 hours after diagnosis;
✓. Chest X-ray showed bilateral infiltration with pulmonary edema; no clinical manifestations of left ventricular hypertension, or pulmonary artery wedge pressure (PAOP) ≤18mmHg.

✕. Patients with severe allergic constitution;
✕. Moderate to severe liver failure (children Pugh score \> 12);
✕. Patients with severe chronic respiratory diseases, PaCO2 \> 50mmhg, and need home oxygen therapy;
✕. Severe trauma occurred within 14 days before screening;
✕. History of malignant tumor (patients with skin basal cell carcinoma in the past can be included);
✕. They are undergoing hemodialysis or peritoneal dialysis;
✕. The patients who had deep venous thrombosis or pulmonary embolism within 90 days;
✕. Acute myocardial infarction occurred within 30 days;

Incidence of adverse reaction

Timeframe: up to 14 days

TTCI

Timeframe: up to 28 days

28-day mortality

Timeframe: up to 28 days

NCT IDNCT04602104

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-10

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. The subjects themselves or their family members voluntarily participate in this study and sign the informed consent form;
✓. 18-70 years old, male or female;
✓. Definitely diagnosed as acute respiratory distress syndrome (ARDS) (according to the Berlin definition and diagnostic criteria of ARDS);
✓. Course of disease \<96 hours after diagnosis;
✓. Chest X-ray showed bilateral infiltration with pulmonary edema; no clinical manifestations of left ventricular hypertension, or pulmonary artery wedge pressure (PAOP) ≤18mmHg.

✕. Patients with severe allergic constitution;
✕. Moderate to severe liver failure (children Pugh score \> 12);
✕. Patients with severe chronic respiratory diseases, PaCO2 \> 50mmhg, and need home oxygen therapy;
✕. Severe trauma occurred within 14 days before screening;
✕. History of malignant tumor (patients with skin basal cell carcinoma in the past can be included);
✕. They are undergoing hemodialysis or peritoneal dialysis;
✕. The patients who had deep venous thrombosis or pulmonary embolism within 90 days;
✕. Acute myocardial infarction occurred within 30 days;