Table 1 The clinical trials of MSCs on ALI/ARDS
From: Mesenchymal stem cells as a potential therapy for COVID-19
No. | Study name (NCT number) | Starting date | Phase | MSCs type and dose | The origin of ALI/ARDS | Key findings/study status |
|---|---|---|---|---|---|---|
1 | Adipose-derived MSCs in ARDS (NCT 01902082) | Nov 2012 | Phase 1b | Intravenous infusion of human adipose MSCs, with 1 × 106/kg | Unknown | Low dose of 1 × 106 adipose-derived MSCs/kg was well tolerated |
2 | MSCs for ARDS (NCT 01775774) | Jul 2013 | Phase 1b dose-escalation | Intravenous infusion of hBM MSCs, with 1, 5, or 10 × 106/kg | Pneumonia or sepsis or aspiration or preeclampsia | All MSCs doses well tolerated No adverse effects detected |
3 | MSCs for treatment of ARDS in stem cell transplant patients (NCT 02804945) | Feb 2017 | Phase 2 | By vein with a maximum dose of 3 × 106 cell/kg one time at day 1 | Unknown | Completed |
4 | Clinical study to assess the safety and preliminary efficacy of HCR040 in ARDS (NCT 04289194) | Dec 2019 | Phase 1–2 | Intravenous administration of allogeneic adipose-derived adult MSCs expanded and pulsed with H2O2, the maximum tolerated dose (1 or 2 × 106 cells/kg) | Unknown | Active, not recruiting |
5 | Repair of ARDS by stromal cell administration (NCT 03042143) | Jan 2019 | Phase 1–2 | Human UC-derived CD362-enriched MSCs, the maximum tolerated dose from phase 1 trial | Unknown | Recruiting |
6 | UC-MSCs therapy in ARDS (NCT 03608592) | Jun 2018 | Not applicable | Intravenous infusion of UC-MSCs, dose 1 × 106/kg | Unknown | Recruiting |
7 | UC-MSCs therapy in ALI (NCT 02444455) | May 2015 | Phase 1–2 | Intravenous infusion of hUB-MSCs, 5 × 105 cell/kg once a day, three times | Unknown | Recruiting |
8 | MSCs in patients with ARDS (NCT 02112500) | Feb 2014 | Phase 2 | intravenously infusion of MSCs | Unknown | Recruiting |
9 | UC-MSCs in the treatment of novel coronavirus severe pneumonia (NCT 04273646) | Feb 2020 | Not applicable | Intravenous 4 times of UC-MSCs (0.5 × 106 UC-MSCs/kg BW) at day 1, 3, 5, 7 | 2019-COVID | Not yet recruiting |
10 | A pilot clinical study on inhalation of MSCs exosomes treating severe novel coronavirus pneumonia (NCT 04276987) | Feb 2020 | Phase 1 | 5 times aerosol inhalation of MSCs-derived exosomes (2.0 × 108 nano vesicles/3 ml) at day 1, 2, 3, 4, 5 | 2019-COVID | Not yet recruiting |
11 | UC-MSCs treatment for the 2019-novel coronavirus pneumonia (NCT 04269525) | Feb 2020 | Phase 2 | Intravenous infusion of UC-MSCs at day 1, 3, 5, 7 | 2019-COVID | Recruiting |
12 | Treatment with MSCs for severe corona virus disease 2019 (NCT 04288102) | Feb 2020 | Phase 1–2 | Intravenous 3 times of MSCs (BW ≥ 70 kg, 4.0 × 107 cells/time; BW < 70 kg, 3.0 × 107 cells/time) at day 0, 3, 6 | 2019-COVID | Not yet recruiting |
13 | MSCs treatment for pneumonia patients infected with 2019 novel coronavirus (NCT 04252118) | Jan 2020 | Phase 1 | Intravenous 3 times of MSCs 3.0 × 107 at day 0, 3, 6 | 2019-COVID | Recruiting |
14 | Efficacy and safety of UC-MSCs for the treatment of severe viral pneumonia (NCT 04282928) | Feb 2020 | Phase 1 | Intravenous infusion of definitive HUC-MSCs (1 × 106 cells/kg × BW (kg) | Influenza infection viral pneumonia | Not yet recruiting |