ARDS
Conditions
Keywords
ARDS, mesenchymal stem cells, Safety, Cytokines
Brief summary
Currently, there is no proven effective pharmacologic treatment available for patients with the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be effective in treating several inflammatory diseases. The main purpose of this study is to assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with ARDS.
Interventions
DRUGMesenchymal stem cells
DRUGPlacebo
Sponsors
Shaoxing Second Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. ARDS diagnosed using Berlin definition 2. Eligible patients were at least 18 years of age had acute onset of ARDS. 3. Bilateral opacities in chest radiography 4. No cardiac failure 5. PaO2/FiO2 ratio \< 200
Exclusion criteria
1. 72 hours after all inclusion criteria met 2. Pre-existing severe diseases of any major organs 3. Pregnancy 4. Pulmonary hypertension 5. Malignant diseases 6. HIV infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the adverse events between mesenchymal stem cell treatment and placebo groups | From day 0 at the start of treatment to day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital indices by treatment group | From admission to discharge | Days in hospital ICU free days at day 28 Ventilator free days at day 28 |
Other
| Measure | Time frame | Description |
|---|---|---|
| cytokines | Day 0 to day 7 | IL-6, IL-8, SP-D, TNF-alpha |
Countries
China
Contacts
Primary ContactGuoping Zheng, MD
Backup ContactJianguo Xu, PhD
Outcome results
None listed