Table 1.
Mesenchymal stem cell (MSC)-based therapy clinical trials for ARDS (acute respiratory distress syndrome).
| NCT No. | Title | Status | Company Name | Disease/Conditions | Route of Administration | Intervention/Mechanism Target | Results | Phase |
|---|---|---|---|---|---|---|---|---|
| NCT01775774 | Human MSCs for acute respiratory distress syndrome | Completed | University of California | ARDS | Intravenous | Participants received 1 × 106, 5 × 106 and 10 × 106 cells/kg body weight of allogenic BM-HMSCs | A single dose of MSCs demonstrated to be safe and was tolerated well | 1 |
| NCT02611609 | A phase 1 and 2 study to assess multistem therapy in acute respiratory distress syndrome | Completed | Athersys, Inc | ARDS | Intravenous | MultiStem® | N/A | 1 and 2 |
| NCT03608592 | Human Umbilical Cord Mesenchymal stem cells (MSC) therapy in ARDS | Recruiting | Lv Haijin, Sun Yat-sen University | ARDS | Intravenous | 60 × 106 UC-MCSs intravenously administered in 2 h | N/A | N/A |
| NCT01902082 | Adipose-derived Mesenchymal stem cells in acute respiratory distress syndrome | Unknown | Shaoxing Second Hospital | ARDS | Intravenous | Participants will receive 1 × 106 Adipose-derived MSCs on day 2. | N/A | 1 |
| NCT02804945 | Mesenchymal Stem cells (MSCs) for the treatment of Acute Respiratory Distress Syndrome (ARDS) in patients with Malignancies | Completed | Anderson Cancer Center | ARDS | Intravenous infusion “MSCs by vein” | Participants received 3 × 106 intravenously administered on day 1 | N/A | 1 |
| NCT03042143 | Repair of Acute Respiratory Distress Syndrome by Stromal cell Administration (COVID-19) (Realist) | Recruiting | Belfast Health and Social Care Trust | COVID/ARDS | Intravenous | Participants will receive max. tolerated dose of human umbilical cord derived CD362 enriched MSCs given in 30–90 min. | N/A | 1 and 2 |
| NCT04347967 | Mesenchymal stem cells for the treatment of Acute Respiratory Distress Syndrome (ARDS) | Not recruiting yet | Meridigen Biotech Co. Ltd. | ARDS | Intravenous Infusion | Participants will receive low, medium, and high doses of UMC119-06 given to 3 different set of people | N/A | 1 |
| NCT03818854 | Mesenchymal Stromal Cells for Acute Respiratory Distress Syndrome (STAT) | Recruiting | University of California | ARDS | Intravenous | Participants will receive 10 × 106 cells given over 60–80 min | N/A | 2 |
| NCT04377334 | Mesenchymal Stem cells (MSCs) in inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS) | Not Recruiting Yet | University Hospital Tuebingen | ARDS/COVID | Intravenous | Participants will receive allogenic bone marrow derived HMSCs | N/A | 2 |
| NCT02444455 | Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury (UCMSC-ALI) | Unknown | Affiliated Hospital to Acadmey of Military Medical Sciences | ARDS/ALI | Intravenous | Participants will/would receive 5 × 105 cells kg/body weight of human UC-MCSs on day 2, 7 and 14 | N/A | 1 and 2 |
| NCT02215811 | Treatment of Severe Acute Respiratory Distress syndrome with allogenic bone marrow-derived Mesenchymal Stromal cells | Unknown | Karolinska University | ARDS | N/A | Participants will/would receive biological MSCs | N/A | 1 |
| NCT02112500 | Mesenchymal stem cell in patients with acute severe respiratory failure (STELLAR) | Unknown | Asan Medical Center | Respiratory Distress Syndrome | Intravenous | Participants will/would receive biological MSCs | N/A | 2 |
| 2019-002688-89 | Phase 1/2 clinical study to assess the feasibility, safety, tolerability, and preliminary efficacy of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome. (included patients COVID-19) | Ongoing | Histocell S.L | ARDS | Intravenous | Participants will receive HCR040 (allogenic adipose derived adult mesenchymal stem cells pulsed with H2O2) | No results available | 1 and 2 |
| 2020-001505-22 | Double-blind, randomized, parallel, placebo-controlled pilot clinical trial, nested in a prospective cohort observational study, for the evaluation of the efficacy and safety of two doses of WJ-MSC in patients with acute respiratory distress syndrome secondary to infection by COVID-19 | Ongoing | Banc de Sang I Teixits | ARDS | Intravenous | Participants will receive 2 doses of WJ-MSCs | N/A | 1 |
| NCT04447833 | Mesenchymal Stromal Cell Therapy for The Treatment of Acute Respiratory Distress Syndrome (ARDS-MSC-205) | Recruiting | Uppsala University | ARDS | Intravenous | 1st 3 participants will receive 1 × 106 and next 6 participants will receive 2 × 106 of allogenic BM-MSCs | N/A | 1 |
| NCT04456361 | Use of Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Caused by COVID-19 | Active, not recruiting | Instituto de Medicina Regenerativa | ARDS, Human COVID-19 | Intravenous | Participants will receive 1 × 108 dose of Wharton jelly MSCs | N/A | 1 |
| NCT03807804 | Efficacy and Safety Study of HLCM051 (MultiStem® for Pneumonic Acute Respiratory Distress Syndrome (ONE-BRIDGE) | Recruiting | Healios K.K. | Respiratory Distress Syndrome | Intravenous | One dose of HCLM0S1 consisting of 9.0 × 108 of cells | N/A | 2 |
| NCT04371393 | MSCs in COVID-19 ARDS | Recruiting | Icahn School of Medicine at Mount Sinai | ARDS, COVID-19 | Intravenous | One dose of 2 × 106 MSCs cells/kg body weight | N/A | 3 |
| NCT02095444 | Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection | Unknown | S-Evans Biosciences Co., Ltd. | ALI/ARDS and multiple organ failure | Intravenous | Participants will receive 1 dose of 1 × 107 menstrual blood stem cells/kg body weight twice a week for 2 weeks | N/A | 1 and 2 |
| NCT04345601 | Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease) | Not recruiting yet | Baylor College of Medicine | ARDS/ COVID-19 | Intravenous | Participants will receive 1 × 108 MSCs. | N/A | Early phase 1 |
| NCT04452097 | Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS | Not recruiting yet | Baylx Inc. | ARDS/COVID-19 | Intravenous | Participants will receive 1 dose of 0.5 × 106, 1.0 × 106 or 1.5 × 106 cells/kg of body weight | N/A | 1 |
| NCT04400032 | Cellular Immuno-therapy for COVID-19 Acute Respiratory Distress Syndrome—Vanguard (CIRCA-19) | Not recruiting yet | Ottawa Hospital Research institute | COVID-19, ARDS | Intravenous | 75 × 106, 150 × 106 and 270 × 106 BM-MSCs given to 2 sets of groups | N/A | 1 |
| NCT04331613 | Safety and Efficacy of CAStem for Severe COVID-19 Associated With/Without ARDS | Recruiting | Chinese Academy of Sciences | COVID-19, Acute Respiratory Distress Syndrome, Pneumonia and Acute Lung Injury | Intravenous | 3 cohorts with 3 patients will receive 3 × 106, 5 × 106 and 10 × 106 | N/A | 1 and 2 |
| NCT04390152 | Safety and Efficacy of Intravenous Wharton’s jelly derived Mesenchymal stem cells in acute respiratory distress syndrome due to COVID-19 | Not recruiting yet | BioXcelleraltor | COVID-19, ARDS | Intravenous | Participants will receive 2 doses of 50 × 106 WJ MSC and hydroxychloroquine, lopinavir or azithromycin and ventilation support | N/A | 1 and 2 |
| NCT04345601 | Mesenchymal Stromal cells for the treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease) | Not recruiting yet | Baylor College of Medicine | COVID-19, ARDS | Intravenous | Participants will be given 1 × 108 MSCs | N/A | 1 |
| NCT04390139 | Efficacy and safety of Evaluation of Mesenchymal stem cells for the treatment of patients with Respiratory Distress Due to COVID-19 (COVIDMES | Recruiting | Banc de Sang i Teixits | COVID-19, ARDS | Intravenous | Participants will receive 1 × 106 cells/kg body weight W-J MSCs on day 1 and day 3 | N/A | 1 and 2 |
| NCT04399889 | Human Cord Tissue- MSCs for COVID-19 | Not recruiting yet | Joanne Kurtzberg, MD | COVID-19, ARDS | Intravenous | Participants will receive hCT-MSCs | N/A | 1 and 2 |
| NCT04355728 | Use of UC-MSCs for COVID-19 Patients | Recruiting | Camillo Ricordi, University of Miami | COVID-19. ARDS, Acute Lung Injury | Intravenous | Participants will receive 1 × 108 UC-MSCs and standard treatment | N/A | 1 and 2 |
| NCT04377334 | Mesenchymal Stem Cells (MSCs) in inflammation-resolution programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS) | Not recruiting yet | University Hospital Tuebingen | COVID-19, ARDS | Intravenous | Participants will receive allogenic bone marrow-derived human mesenchymal stem cells | N/A | 2 |
| NCT04348461 | Battle Against COVID-19 Using Mesenchymal Stromal Cells | Not recruiting yet | Instituto de Investigacóin Sanitaria de la Fundación Jieménez Díaz | COVID-19, Respiratory Distress Syndrome | Intravenous | Participants to receive 2 doses of 1.5 × 106 ad-MSCs cells/kg body weight | N/A | 2 |
| NCT04367077 | MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) (MACoVIA) | Recruiting | Athersys | COVID-19, ARDS | Intravenous | Participants to receive doses of MultiStem | N/A | 2 and 3 |
N/A = Not yet available.