Table 1.
Randomized Clinical Trials of Mesenchymal Stromal Cell Therapies in Patients with Classical Acute Respiratory Distress Syndrome
| Number of Patients |
Patient Population | MSC Therapy Regimen |
Design | Biological Signal | Adverse Events (n) |
Mortality [n (%)]* |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment | Control | Cell Source | Dose Size | Number of Doses | Treatment | Control | Treatment | Control | ||||
| Zheng et al. (2014) (8) | 6 | 6 | Early ARDS; invasive MV (PFR ⩽ 300 mm Hg) | Adipose-derived MSCs | 1 × 106 cells/kg | 1 | Placebo control | No (cytokines) | 1† | 0† | 1 | 2 |
| Matthay et al. (2019) (9) | 40 | 20 | Early ARDS; invasive MV (PFR ⩽ 200 mm Hg) | Bone marrow cord MSCs | 10 × 106 cells/kg | 1 | Placebo control | Yes (biomarkers) | 0† | 0† | 12/40 (30) | 3/20 (15) |
| Bellingan et al. (2022) (11) | 20 | 10 | Early ARDS; invasive MV (PFR ⩽ 200 mm Hg) | Bone marrow cord MAPCs | 9 × 108 cells | 1 | Placebo control | Yes (biomarkers) | 1†/18‡ | 0†/6‡ | 2/20 (10) | 4/10 (40) |
| Ichikado et al. (2023) (12) | 20 | 10 | Pneumonia ARDS with early fibroproliferation | Bone marrow cord MAPCs | 9 × 108 cells | 1 | Placebo control | No (cytokines) | 5†/20‡ | 0†/10‡ | 5/19 (26) | 3/7 (43) |
Definition of abbreviations: ARDS = acute respiratory distress syndrome; MAPC = multipotent adult progenitor cell; MSC = mesenchymal stromal cell; MV = mechanical ventilation; PFR = PaO2:FiO2 ratio.
*
Mortality at the latest time point reported in the study.
†
Adverse events possibly related to therapy.
‡
Total number of adverse events (some patients had more than one adverse event).