Table 2.
Summary of ongoing headStartclinical trialsheadEnd related to stem cells and SARS, MERS and ARDS in ClinicalTrials.gov
| | ClinicalTrials.gov Identifier | Conditions | Study design | Objective | Study Start | Locations | Participants / Ages Eligible for Study | Interventions | Status |
|---|---|---|---|---|---|---|---|---|---|
| Coronavirus | |||||||||
| Phase 1 | NCT02215811 | ARDS on extracorporeal membrane oxygenation (ECMO) | Multi-center, open-label, non-randomized controlled trial. | Patients will be enrolled and receive allogeneic BM-MSCs. | March 2014 | Sweden | 10 / 18 | Allogeneic BM-MSCs | Unknown status |
| NCT04276987 | SARS | Single-arm design, open label, combined interventional clinical trial, | To explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogenic adipose MSCs in the treatment of severe patients hospitalized with novel coronavirus pneumonia. | February 15, 2020 | China | 30 / 18–75 | MSCs-derived exosomes | Not yet recruiting | |
|
(Early Phase I) |
Pulmonary alveolar proteinosis COPD Idiopathic pulmonary fibrosis |
Interventional, non-randomized | To use of autologous, cellular stromal vascular fraction (cSVF) deployed intravenously to examine the anti-inflammatory and structural potential to improve the residual, permanently damaged alveolar tissues of the lungs. | March 25, 2020 | United States | 10 / 18–90 | Cellular stromal vascular fraction (cSVF) | Enrolling by invitation | |
|
Phase 1 Phase 2 |
NCT04333368 | ARDS | Interventional, randomized | To treat intubated-ventilated patients with a SARS-CoV2-related ARDS of less than 96 h by three intravenous infusions of umbilical cord Wharton’s jelly-derived mesenchymal stromal cells (UC-MSC). | April 6, 2020 | France | 60 / 18 | UC-MSCs | Not yet recruiting |
|
(Phase 1 Phase 2) |
ARDS | Interventional, randomized | The trial has two groups, each with 12 subjects (n = 24). All eligible subjects will be randomized to either the treatment group or standard of care, and randomization will be stratified by ARDS severity. | April 25, 2020 | United States | 24 / 18 | UC-MSCs | Recruiting | |
| NCT04346368 | SARS | Interventional, randomized | To investigate the safety and efficacy of intravenous infusion of MSCs in severe patients with COVID-19. | April 2020 | China | 20 / 18–75 | BM-MSCs | Not yet recruiting | |
| Phase 2 | NCT04288102 | SARS | Prospective, double-blind, multi-center, randomized trial | To assess treatment with three intravenous doses of MSCs compared with placebo. | March 5, 2020 | China | 90 / 18–75 | MSCs | Recruiting |
| NCT04299152 | SARS | Prospective, two-arm, partially masked, single center clinical study | To assess the safety, feasibility, and efficacy of Stem Cell Educator (SCE) therapy for the treatment of patients with SARS-CoV-2. | May 10, 2020 | Not mentioned | 20 / 18–60 | SCE-Treated Mononuclear cells apheresis | Not yet recruiting | |
| - Applicable | NCT04273646 | Pneumonia | Interventional, randomized | To investigate efficiency and safety of UC-MSCs in treating severe pneumonia patients infected with 2019-nCoV. | April 20, 2020 | China | 48 / 18–65 | UC-MSCs | Not yet recruiting |
| Not related to coronavirus | |||||||||
|
Phase 1 Phase 1 Phase 1 Phase 2 |
NCT02215811 | ARDS | Multi-center, open-label, non-randomized controlled trial. | To treat ARDS with allogeneic bone marrow-derived MSCs. | March 2014 | Sweden | 10 / 18 | Allogeneic BM-MSCs | Unknown |
| NCT01902082 | ARDS | Interventional, randomized | To assess the safety of allogeneic adipose-derived mesenchymal stem cellsheadEnd in patients with ARDS. | November 2012 | China | 20 / 18–90 | MSCs | Unknown | |
| NCT02095444 |
ARDS Multiple organ failure |
Interventional, single group assignment | To determine whether human menstrual blood-derived stem cells are effective in the treatment of infection of H7N9 virus-caused acute lung injury. | March 2014 | China | 20 / 18 | Menstrual blood stem cells | Unknown | |
|
(Phase 1 Phase 2) |
ARDS | Interventional, randomized | To assess the feasibility, safety, and tolerability of the administration of HCR040 in patients with ARDS. | December 10, 2019 | Spain | 26 / 18 | HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult MSCs expanded and pulsed with H2O2 | Active, not recruiting | |
|
Phase 2 Phase 2 |
NCT03818854A | ARDS | Randomized, double-blind, placebo-controlled, multi-center | An assignment will be made by computer-generated randomization to administer either hMSCs therapy or placebo with a 1:1 allocation to the hMSCs:placebo arms. | November, 2019 | United States | 120 / 18 |
BM-MSCs Cell reconstitution media |
Recruiting |
| NCT02112500 | ARDS | Pilot study, interventional, single group assignment | To evaluate the efficacy and safety of MSCs treatment in patients with respiratory failure. | February 2014 | Korea | 10 / 20–80 | MSCs | Unknown | |
| - | NCT03608592 | ARDS | Interventional, single group assignment | A package of 100 ml normal saline with 10^6/kg UC-MSCs suspension will be infused from central venous catheter. | June 1, 2018 | China | 26 / 18 | UC-MSCs | Recruiting |
BM-MSCs, Bone Marrow-Derived Mesenchymal Stem Cell; UC-MSCs, Umbilical cord derived MSCs