Table 2. Ongoing and results of phase 1 and phase 2a clinical trials.
Study title | Register number | Sepsis/ARDS | Cell type | Phase | Dose and via | Start date | Finish date | Country | Results |
---|---|---|---|---|---|---|---|---|---|
Adipose-derived mesenchymal stem cells in acute respiratory distress syndrome | NCT01902082 | ARDS | MSC | Phase 1 | 1×106 intravenous | November 2012 | November 2014 | China | (66) |
Russian clinical trial of mesenchymal cells in patients with septic shock and severe neutropenia | NCT01849237 | Sepsis | MSC | Phase 1/2 | 1–2 millions/kg/day intravenous | December 2012 | May 2015 | Russia | (67) |
Human mesenchymal stem cells for acute respiratory distress syndrome (START) |
NCT01775774 NCT02097641 |
ARDS | MSC | Phase 1/2 | 1 or 5 or 10 million cells/kg | July 2013 | February 2017 | USA | (68) |
Cellular immunotherapy for septic shock: a phase I trial (CISS) | NCT02421484 | Sepsis | MSC | Phase 1 | 0.3 or 1 or 3 million cells/kg, | May 2015 | June 2017 | Canada | – |
Treatment of severe acute respiratory distress syndrome with allogeneic bone marrow-derived mesenchymal stromal cells | NCT02215811 | ARDS | MSC | Phase 1 | Not known. Cells are combined with ECMO | March 2014 | December 2015 | Sweden | – |
Human umbilical-cord-derived mesenchymal stem cell therapy in acute lung injury (UCMSC-ALI) | NCT02444455 | ARDS | MSC | Phase 1/2 | 5×105/kg intravenous | May 2015 | December 2017 | China | – |
A phase 1/2 study to assess MultiStem® Therapy in acute respiratory distress syndrome (MUST-ARDS) | NCT02611609 | ARDS | Multistem (MSC) | Phase 1/2 | Not known | January 2016 | November 2018 | USA/UK | – |
Effects of administration of mesenchymal stem cells on organ failure during the septic shock (CSM choc) | NCT02883803 | Sepsis | MSC | Phase 1 | 106/kg intravenous | December 2016 | December 2019 | France | – |
Mesenchymal stem cells (MSCs) for treatment of acute respiratory distress syndrome (ARDS) in stem cell transplant patients | NCT02804945 | ARDS | MSC | Phase 2 | 3×106 cell/Kg intravenous | February 2017 | February 2019 | USA | – |
Repair of acute respiratory distress syndrome by stromal cell administration (REALIST) | NCT03042143 | ARDS | MSC | Phase 1/2 | 2 doses, not specified | September 2017 | September 2020 | UK | – |
ARDS, acute respiratory distress syndrome; MSC, multipotent stem (or stromal) cells.