Table 1 Clinical trials of cell-based therapies in COVID-19 patients registered in clinicaltrials.gov
| Â | Title | ID | Interventions | Primary outcome | Age | Phases | Enrollment | Location |
|---|---|---|---|---|---|---|---|---|
1 | The Mesenchymal coviD-19 Trial: a Pilot Study to Investigate Early Efficacy of MSCs in Adults With COVID-19 (MEND | NCT04537351 | CYP-001 | Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between in 7 days | < 18 years | Phase I Phase II | 24 | Australia |
2 | Treatment of Covid-19 Associated Pneumonia with Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells | NCT04382547 | Allogenic pooled olfactory mucosa-derived MSCs versus control | Treatment: Number of cured patients in 3 weeks | 18 to 70 Years | Phase I Phase II | 40 | Belarus |
3 | Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection | NCT04445454 | BM-MSC | Adverse events in 28 days | 18 to 70 years | Phase 1 Phase 2 | 20 | Belgium |
4 | MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome | NCT04525378 | MSCs | Intrahospital mortality, incidence of adverse events in 28 days and quantification of biomarkers | ≥ 18 years | Phase 1 | 20 | Brazil |
5 | This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia | NCT04315987 | NestaCell® (MSCs) versus Placebo | Change in clinical condition in 10 days | ≥ 18 years | Phase II | 90 | Brazil |
6 | Safety and Feasibility of Allogenic MSC in the Treatment of COVID-19 | NCT04467047 | MSCs | Overall survival in 60 days | Child, Adult, Older Adult | Phase I | 10 | Brazil |
7 | Cellular Immuno-Therapy for COVID-19 Acute Respiratory Distress Syndrome - Vanguard (CIRCA-19) | NCT04400032 | BMCs | Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 to determine the maximum feasible tolerated dose (MFTD) of BM-MSCs given to patients with COVID-19 | ≥ 18 years | Phase I | 9 | Canada |
8 | Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia | NCT04429763 | UC-MSCs versus Placebo | Clinical deterioration or death in 4 weeks | 18 to 79 Years | Phase II | 30 | Colombia |
9 | Safety and Efficacy of Intravenous Wharton's Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19 | NCT04390152 | WJ-MSC versus control | Evaluation of efficacy of WJ-MSC defined by mortality at 28 days of application | 18 to 80 years | Phase I Phase II | 40 | Colombia |
10 | Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With COVID-19 | NCT04252118 | MSCs | Size of lesion area by chest radiograph or CT and side effects in 28 days | 18 to 70 years | Phase 1 | 20 | China |
11 | Clinical Research of Human Mesenchymal Stem Cells in the Treatment of COVID-19 Pneumonia | NCT04339660 | UC-MSCs versus Placebo | Immune function and blood oxygen saturation | 18 to 75 years | Phase 1 Phase 2 | 30 | China |
12 | Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019 | NCT04371601 | MSCs versus control | Improvement of pulmonary function in 12 months | 18 to 70 years | Phase I | 60 | China |
13 | Safety and Efficacy Study of Allogeneic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients | NCT04336254 | DPSCs versus Placebo | Clinical improvement in 28 days | 18 to 65 years | Phase 1 Phase 2 | 20 | China |
14 | Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19 | NCT04273646 | UC-MSCs versus Placebo | Evaluation of pneumonia improvement | 18 to 65 years | Not Applicable | 48 | China |
15 | Bone Marrow-Derived Mesenchymal Stem Cell Treatment for Severe Patients with Coronavirus Disease 2019 (COVID-19) | NCT04346368 | BM-MSCs versus Placebo | Changes of oxygenation index (PaO2/FiO2) at baseline, 6-hour, day 1, day 3 week 1, week 2, week 4, month 6 Evaluation of pneumonia improvement | 18 to 75 years | Phase I Phase II | 20 | China |
16 | Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating Severe Novel Coronavirus Pneumonia | NCT04276987 | MSCs-Exo | Safety evaluation within 28 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE) | 18 to 75 years | Phase I | 24 | China |
15 | Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells | NCT04302519 | Dental pulp MSCs | Disappear time of ground-glass shadow in the lungs in 14 days | 18 to 75 years | Phase I | 24 | China |
16 | Umbilical Cord (UC)-Derived Mesenchymal Stem Cells (MSCs) Treatment for the 2019-novel Coronavirus (nCOV) Pneumonia | NCT04269525 | UC-MSCs | Oxygenation index on after 14 days | 18 to 80 years | Phase II | 16 | China |
17 | Treatment with Human Umbilical Cord-derived Mesenchymal Stem Cells for Severe Corona Virus Disease 2019 (COVID-19) | NCT04288102 | UC-MSCs versus Placebo | Change in lesion proportion (%) of full lung volume from baseline to day 28 Evaluation of pneumonia improvement | 18 to 75 years | Phase II | 100 | China |
18 | Cell Therapy Using Umbilical Cord-derived Mesenchymal Stromal Cells in SARS-CoV-2-related ARDS | NCT04333368 | UC-MSC versus NaCl 0.9% | PaO2/FiO2 ratio from baseline to day 7 | ≥ 18 years | Phase 1 Phase 2 | 40 | France |
19 | Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS) | NCT04377334 | BM-MSCs versus control | Lung injury score in 10 days Improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points | ≥ 18 years | Phase II | 40 | Germany |
20 | Administration of Allogenic UC-MSCs as Adjuvant Therapy for Critically-Ill COVID-19 Patients | NCT04457609 | UC-MSCs versus control group | Clinical improvement in 15 days | 18 to 95 years | Phase I | 40 | Indonesia |
21 | Treatment of Severe COVID-19 Patients using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia | NCT04753476 | S-MSCs versus control | Change in patients clinical manifestation in 1 months (mild, moderate, or severe) | Child, Adult, Older Adult | Phase II | 48 | Indonesia |
22 | Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients (DW-MSC) | NCT04535856 | MSCs versus Placebo | Treatment-emergent adverse event All adverse reactions in treatment group in 28 days | ≥ 19 years | Phase I | 9 | Indonesia |
23 | Mesenchymal Stem Cell Therapy for SARS-CoV-2-related ARDS | NCT04366063 | MSCs and EVs | Adverse events in 28 days and blood oxygen saturation | 18 to 65 years | Phase 2 Phase 3 | 60 | Iran |
24 | An Exploratory Study of ADR-001 in Patients with Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19) | NCT04522986 | MSCs | Safety: adverse event in 12 weeks | ≥ 20 years | Phase I | 6 | Japan |
25 | Mesenchymal Stem Cell for Acute Respiratory Distress Syndrome Due for COVID-19 | NCT04416139 | UC-MSCs | PaO2/FiO2 ratio and clinical changes in 3 weeks | 18 years and older | Phase 2 | 10 | Mexico |
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27 | Mesenchymal Stem Cells in Patients Diagnosed With COVID-19 | NCT04611256 | MSCs versus control | Change form baseline in Arterial oxygen saturation up to 25 days Pulmonary lesion area will be taken by a chest X-ray or computed axial tomography | 18 to 65 years | Phase I | 20 | Mexico |
28 | Use of Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Caused by COVID-19 | NCT04456361 | WJ-MSCs | Oxygen saturation Baseline, and at days 2, 4 and 14 post-treatment Number of patients with changes in percentage of resting oxygen saturation (%O2) | ≥ 18 years | Phase I | 9 | Mexico |
29 | Efficacy of Intravenous Infusions of Stem Cells in the Treatment of COVID-19 Patients | NCT04437823 | UC-MSCs | Adverse events, improvements in chest radiograph or chest CT scan in 30 days | 30 to 70 years | Phase 2 | 20 | Pakistan |
30 | Mesenchymal Stem Cell Infusion for COVID-19 Infection | NCT04444271 | MSC versus Placebo | Overall survival in 30 days | 10 years and older | Phase 2 | 20 | Pakistan |
31 | Investigational Treatments for COVID-19 in Tertiary Care Hospital of Pakistan | NCT04492501 | MSCs versus control | Survival in 28 days | 18 to 90 years | Not Applicable | 600 | Pakistan |
32 | Treatment of Severe COVID-19 Pneumonia with Allogeneic Mesenchymal Stromal Cells (COVID_MSV) | NCT04361942 | MSC versus Placebo | Proportion of patients who have achieved withdrawal of invasive mechanical ventilation in 7 days and mortality rate in 28 days | ≥18 years | Phase 2 | 24 | Spain |
33 | Clinical Trial of Allogeneic Mesenchymal Cells from Umbilical Cord Tissue in Patients With COVID-19 | NCT04366271 | UC-MSC versus Standard of care | Mortality rate in 28 days | 40 to 80 years | Phase 2 | 106 | Spain |
34 | Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19 | NCT04366323 | AD-MSCs | Adverse event rate in 12 months; survival rate in 28 days | 18 to 80 years | Phase 1 Phase 2 | 26 | Spain |
35 | BAttLe Against COVID-19 Using MesenchYmal Stromal Cells | NCT04348461 | AD-MSCs versus control | Efficacy of the administration of allogeneic AD- MSCs by survival rate in 28 days Safety of the administration of allogeneic AD-MSCs by adverse event rate in 6 months | ≥ 18 years | Phase II | 100 | Spain |
36 | Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients with Respiratory Distress Due to COVID-19 (COVIDMES) | NCT04390139 | WJ-MSC versus Placebo | All-cause mortality at day 28 | 18 to 70 years | Phase I Phase II | 30 | Spain |
37 | Treatment of Severe COVID-19 Pneumonia with Allogeneic Mesenchymal Stromal Cells (COVID-MSV) | NCT04361942 | MSCs versus Placebo | Proportion of patients who have achieved withdrawal of invasive mechanical ventilation in 7 days | ≥ 18 years | Phase II | 24 | Spain |
38 | Mesenchymal Stromal Cell Therapy for The Treatment of Acute Respiratory Distress Syndrome | NCT04447833 | BM-MSC | Incidence of pre-specified adverse events in 10 days | 18 to 65 years | Phase 1 | 9 | Sweden |
39 | Investigational Treatments for COVID-19 in Tertiary Care Hospital of Pakistan | NCT04492501 | MSCs versus control | Survival in 28 days | 18 to 90 years |  | 600 | Pakistan |
40 | Evaluation of Safety and Efficiency of Method of Exosome Inhalation in SARS-CoV-2 Associated Pneumonia | NCT04491240 | EXO 1, EXO 2 versus Placebo | Number of participants with non-serious and serious adverse events during trial 30 days after clinic discharge Number of participants with non-serious and serious adverse during inhalation procedure after each inhalation during 10 days | 18 to 65 years | Phase I Phase II | 30 | Russian |
41 | Safety and Efficiency of Method of Exosome Inhalation in COVID-19 Associated Pneumonia | NCT04602442 | EXO 1, EXO 2 versus Placebo | Number of participants with non-serious and serious adverse events during trial in 2 months Number of participants with non-serious and serious adverse during inhalation procedure in 10 days during inhalation procedures | 18 to 65 years | Phase II | 90 | Russian |
42 | Clinical Use of Stem Cells for the Treatment of Covid-19 | NCT04392778 | MSC versus control | Clinical improvement in 3 months | 40 to 60 years | Phase 1 Phase 2 | 30 | Turkey |
43 | Mesenchymal Stem Cells Therapy in Patients With COVID-19 Pneumonia | NCT04713878 | MSCs | Clinical symptoms as respiratory distress | 18 to 90 years | Not Applicable | 21 | Turkey |
44 | Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) (COVID-19) | NCT03042143 | UC-MSCs versus Plasma-Lyte | Oxygenation index in 7 days and incidence of serious adverse events in 28 days | ≥16 years | Phase 1 Phase 2 | 75 | United Kingdom |
45 | Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) with Cryopreserved Allogeneic P_MMSCs and UC-MMSCs | NCT04461925 | P-MMSCs versus Antibiotics/ Hormones/ Anticoagulant Therapy | PaO2/FiO2 ratio and mortality rate in 28 days | 18 to 75 years | Phase 1 Phase 2 | 30 | Ukraine |
46 | Use of UC-MSCs for COVID-19 Patients | NCT04355728 | UC-MSCs + Heparin alongside best supportive care versus Vehicle + Heparin alongside best supportive care | Incidence of pre-specified infusion-associated adverse events in 5 days and incidence of severe adverse events in 90 days | ≥18 years | Phase 1 Phase 2 | 24 | United States |
47 | hCT-MSCs for COVID-19 ARDS | NCT04399889 | UC-MSCs versus Standard care | Safety of the investigational product in 28 days | ≥18 years | Phase 1 Phase 2 | 30 | United States |
48 | Umbilical Cord Lining Stem Cells (ULSC) in Patients With COVID-19 ARDS (ULSC) | NCT04494386 | UC-MSCs versus Placebo | Incidence of dose-limiting toxicity and adverse events in 12 months | ≥18 years | Phase 1 Phase 2 | 60 | United States |
49 | Cord Blood-Derived Mesenchymal Stem Cells for the Treatment of COVID-19 Related Acute Respiratory Distress Syndrome | NCT04565665 | CB-MSC | Incidence of serious adverse events | ≥18 years | Phase II | 70 | United States |
50 | Study of Intravenous Administration of Allogeneic Adipose-Derived Mesenchymal Stem Cells for COVID-19-Induced Acute Respiratory Distress | NCT04728698 | COVI-MSCs versus Placebo | Mortality at day 28 | ≥ 18 years | Phase II | 100 | United States |
51 | A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Allogeneic Mesenchymal Stem Cell Therapy (HB-adMSCs) to Provide Protection Against COVID-19 | NCT04348435 | HB-adMSCs versus Placebos | Incidence of hospitalization for COVID-19 (week 0 through week 26 end of study Number of subjects that must be hospitalized for COVID-19 during the conduct of this study | ≥ 18 years | Phase II | 100 | United States |
52 | Regenerative Medicine for COVID-19 and Flu-Elicited ARDS Using Longeveron Mesenchymal Stem Cells (LMSCs) | NCT04629105 | LMSCs versus Placebo | Incidence of treatment-emergent serious adverse events (TE-SAEs) within 4 weeks after treatment | ≥ 18 years | Phase I | 70 | United States |
53 | A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) to Provide Protection Against COVID-19 | NCT04349631 | HB-adMSCs | Number of subjects that require hospitalization for COVID-19 | ≥ 65 years | Phase II | 56 | United States |
54 | Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19 | NCT04362189 | HB-adMSC versus placebo | Interleukin-6, C-reactive protein, oxygenation, NF alpha, IL-10 from change from baseline and time to return to room air | ≥ 18 years | Phase II | 100 | United States |
55 | Umbilical Cord Tissue (UC) Derived Mesenchymal Stem Cells (MSCs) Versus Placebo to Treat Acute Pulmonary Inflammation Due to COVID-19 | NCT04490486 | UC-MSCs versus Placebo | Safety of UCMSCs will be reported as the percentage of participants in each treatment group that experienced a treatment-related serious adverse events (SAEs) | ≥ 18 years | Phase I | 21 | United States |
56 | A Phase II Study in Patients with Moderate to Severe ARDS Due to COVID-19 | NCT04780685 | hMSCs versus placebo | Survival in 14 days post-treatment | ≥ 18 years | Phase II | 40 | United States |
57 | ACT-20 in Patients with Severe COVID-19 Pneumonia | NCT04398303 | CT-20-MSC, or ACT-20-CM versus Placebo | Mortality day 30 post-treatment | 18 to 85 years | Phase I Phase II | 70 | United States |
58 | MSCs in COVID-19 ARDS | NCT04371393 | Remestemcel-L versus Placebo | Number of all-cause mortality within 30 days of randomization Change in IL6, IL-8, TNF-alpha inflammatory marker level in 7,14, 21, 30 days | 18 to 75 years | Phase III | 223 | United States |
59 | Multiple Dosing of Mesenchymal Stromal Cells in Patients with ARDS (COVID-19) | NCT04466098 | MSCs versus Placebo | Incidence of grade 3–5 infusional toxicities and predefined hemodynamic or respiratory adverse events related to the infusion of MSC in 6 hours of the start of the infusion | 18 to 80 years | Phase II | 30 | United States |
60 | A Study of Cell Therapy in COVID-19 Subjects with Acute Kidney Injury Who Are Receiving Renal Replacement Therapy | NCT04445220 | SBI-101 versus control | Safety and tolerability as measured by incidence of IP-related serious adverse events in 180 | ≥ 18 years | Phase I Phase II | 22 | United States |
61 | Study of Descartes-30 in Acute Respiratory Distress Syndrome | NCT04524962 | Descartes 30 | To assess the safety of Descartes-30 in patients with moderate-to-severe ARDS in 2 years | ≥ 18 years | Phase I Phase II | 30 | United States |
62 | Mesenchymal Stem Cells for the Treatment of COVID-19 | NCT04573270 | Primepro versus Placebo | Survival rate in COVID-19 infected patients admitted to hospital for complications Contraction rate of COVID-19 in healthy healthcare workers following patients admitted to hospital for complications due to COVID-19 | ≥ 18 years | Phase I | 40 | United States |
63 | Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease) | NCT04362189 | MSCs versus control | Treatment-related serious adverse events (tSAEs) 28 days post cell infusion and Change in clinical status in 14 days post infusion | ≥ 18 years | Phase I Phase II | 30 | United State |
64 | Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation | NCT04397796 | BM-Allo.MSC versus Placebo | Incidence of AEs, mortality, death, within 30 days of randomization Number of ventilator-free days in 60 days | ≥ 18 years | Phase I | 45 | United States |
65 | The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19 (ARDOXSO) | NCT04798716 | MSC-Exo | Evaluate the efficacy of ARDOXSO™ as an interventional exosome therapy in COVID-19 patients in 90 days | ≥ 18 years | Phase I Phase II | 55 | United States |
66 | Adipose Mesenchymal Cells for Abatement of SARS-CoV-2 Respiratory Compromise in COVID-19 Disease | NCT04352803 | AD-MSCs | Safety Incidence of unexpected adverse events within 28 days following IV administration of MSCs and efficacy | 18 to 90 Years | Phase I | 20 | United States |
67 | Use of hUC-MSC Product (BX-U001) for the Treatment of COVID-19 With ARDS | NCT04452097 | HU-MSCs versus Placebo | Incidence of infusion-related adverse events in day 3 Incidence of any treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TE-SAEs) in day 28 | 18 to 80 years | Phase I Phase II | 39 | United States |