Table 4.
List of registered stem cell therapy based clinical trials for COVID-19.
| Author, Year | Study design | Status | Population | Intervention/ Details of stem cell use (Stem size) | Control (sample size) |
Outcome |
|---|---|---|---|---|---|---|
| AlZoubi et al. 2020 [53] | Phase I Interventional | Recruiting | 5 Patients positively diagnosed with COVID-19 (18 years and older) | Wharton's Jelly-Mesenchymal stem cell | Primary Outcome: Improvement of clinical symptoms(fever, pneumonia, respiratory distress, sneezing, cough, diarrhea) | |
| Guillory et al. 2020 [54] | Phase 2 multi-center, double-blind, randomized, placebo-control clinical trial | Not yet recruiting | 200 (18 years and older) |
Autologous Adipose Tissue-Derived MSCs (Celltex-AdMSCs) | Phase 2 Placebo group | Primary Outcome: Safety and Tolerability Incidence of COVID-19 in study and control group |
| Akram et al. 2020 [55] | Prospective, Randomized Phase 2 Clinical Trial | Recruiting | 20 (10 years and older) |
MSCs | Phase 2 Placebo Group | Primary Outcome: Overall survival at 30 days post intervention |
| Q et al. 2020 [56] | Single-center, Prospective, Randomized Clinical Trial | Recruiting | 20 (18−65 years old) |
Allogeneic Human Dental Pulp Mesenchymal | Placebo group (3 mL of 0.9 % saline) | Primary Outcome: Time to Clinical Improvement |
| Vanegas et al. 2020 [57] | Phase 2 | Recruiting | 30 (18−79 years old) |
Umbilical cord derived MSCs | Placebo group | Primary Outcome: Clinical deterioration or death |
| Iglesias et al. 2020 [58] | Pilot Study | Recruiting | 10 (18 years and older) |
MSCs from umbilical cord allogenic | historical controls treated in INCMNSZ | Primary Outcome: clinical, biochemical, inflammatory and immune changes |
| Filho et al.2020 [59] | Phase 2 (Exploratory clinical study) | Recruiting | 90 (18 years and older) |
NestaCell® MSCs | Matching Placebo | Primary Outcome: change in clinical condition |
| Cheng et al.2020 [60] | Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial | Enrolling by invitation | 100 (Child, Adult, Older Adult) |
allogeneic adipose-derived MSCs | Placebo (Saline) | Primary Outcome: Incidence of hospitalization and symptoms associated with COVID-19 |
| Perez et al. 2020 [61] | Pilot phase, open label, non-randomized study | Active but not recruiting | 9 (18 years and older) |
MSCs derived from Wharton Jelly of Umbilical cords | Primary Outcome: Oxygen Saturation | |
| Gil et al. 2020 [62] | Phase I/II clinical trial | Recruiting | 26 (18–80 years old) |
Allogenic Adipose Tissue-Derived Mesenchymal | Control: No intervention | Primary Outcome: Safety and efficacy via ADR and survival rate |
| Cheng et al.2020 [63] | Phase II, Open Label, Single-Center, Clinical Trial | Enrolling by Invitation | 56 (Child, Adult, Older Adult) |
Autologous adipose-derived MSCs | Primary Outcome: Incidence of hospitalization and symptoms associated with COVID-19 | |
| Cheng et al. 2020 [64] | Open, single center, single arm test design | Not yet recruiting | 24 (18−75 years old) |
Dental pulp MSCs | Primary Outcome: Time of disappearance of ground-glass shadow in the lungs | |
| Shi et al. 2020 [65] | Phase 1 multicentric trial | Recruiting | 20 | Conventional treatment plus MSCs | Conventional Control Group | Primary Outcome: Evaluation of Pneumonia Improvement and Side-effects |
| Li et al. 2020 [66] | Phase 1/2 Randomized Controlled Trial | Not yet recruiting | 20 (18−75 years) |
BMMSCs | Conventional treatment plus placebo | Evaluation of pneumonia improvement and safety assessment |
| Wang et al. 2020 [67] | Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Trial | Active not recruiting | 100 (18−75 years) |
Human Umbilical Cord- MSCs | Standard of care plus 3 does of placebo | Evaluation of Pneumonia Improvement |
| Tarar et al. 2020 [68] | Phase 2 RCT | Recruiting | 20 (30−70 years) |
Umbilical Cord- MSCs | Treatment will be done for five subjects under Standard of Care | Assessment of Pneumonia and side effects. |
| Hancharou et al. 2020 [69] | Phase 1/2 | Enrolling by invitation | 40 (18−70 years) |
Allogenic pooled olfactory mucosa-derived mesenchymal | Standard Treatment | Number of patients cured |
| Liu et al. 2020 [70] | Phase 1/2 RCT | Recruiting | 30 (18−75 years) |
hMSC’s | Conventional treatment and Placebo intravenously | Improvement and recovery time of inflammatory and immune factors |
| Fujian et al. [71] 2020 | Early Phase 1 | Active not recruiting | 60 (18−70 years old) |
Umbilical Cord MSCs with Oseltamivir, hormone and oxygen therapy | oseltamivir, hormones, oxygen therapy, mechanical ventilation and other supportive therapies | Improvement of pulmonary function |
| Nouri et al. 2020 [72] | Phase 2−3 Clinical Trial | Recruiting | 60 18−65 years |
MSCs | Conventional therapy and supportive therapy | Evaluation of Pneumonia Improvement and safety assessment |
| [73] | Prospective Non-Interventional Study | Active, not recruiting | 40 3 Months and older |
Allogeneic Haematopoietic Stem Cell Transplantation | Comparison of inflammatory/immunological biomarkers | |
| Ricordi et al. 2020 [74] | Phase1/2 double blinded trial | Recruiting | 24 18 years and older |
Umbilical Cord Mesenchymal + Heparin along with best supportive care | Heparin + Supportive therapy | Assessment of safety |
| Thakur et al. 2020 [75] | Randomized, Placebo-Controlled, Double-Blind, Single Center, Phase 2 Trial | Not yet recruiting | 100 Child, Adult, Older Adult |
allogeneic adipose-derived MSCs | Placebo (Saline) | Detection of the changes from baseline for inflammatory markers, and oxygenation, and reduction in time for a negative PCR test result. |
| Adas et al. 2020 [76] | Prospective Double Controlled Study | Recruiting | 30 (40−60 years) |
MSCs | Patients that are on a ventilator and will receive saline injections | Covid-19 infection related symptom improvement. |
| Itticheria et al. 2020 [77] | Prospective, two-arm, partially masked, single center clinical study | Not yet recruiting | 20 18-60 years |
Stem cell Educator-Treated Mononuclear cells Apheresis | Conventional treatment of patients with SARS-CoV-2 | Patient number who could not complete the SCE therapy |
| [78] | NA | Withdrawn | 0 18−75 years |
hUC-MSC | ---- | ----- |
| Liao et al. 2020 [79] | Phase 1 Study | Not yet recruiting | 9 18-80 years old |
hUC-MSC (BX-U001) + supportive care | Assessment of safety | |
| Juan et al. 2020 [80] | Two-treatment,Randomized, Controlled, Multicenter Clinical Trial | Not yet recruiting | 100 | Allogeneic and expanded adipose tissue-derived MSCs | Regular respiratory distress treatment | Efficacy and safety assessment |
| Rosenberger et al. 2020 [81] | Prospective Phase II Study | Not yet recruiting | 40 18 and above |
MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS | No intervention | Improvement of lung injury score |
| Qi et al. 2020 [82] | Phase 1 and 2 | Recruiting | 9 18−70 years |
Human Embryonic Stem Cells Derived M cells (CAStem) | Safety and efficacy | |
| Gelinjns et al. 2020 [83] | Randomized Phase 3 clinical trial | Recruiting | 300 18 years and older |
MSCs (Remestemcel-L) | Placebo | Number of all-cause mortality |
| Coll et al. 2020 [84] | Prospective, Double-blind, Randomized, Parallel, Placebo-controlled Pilot Clinical Trial | Recruiting | 30 18−75 years old |
XCEL-UMC-BETA (WJ-MSC) | Placebo | Number of patients who died |
| Stewart et al. 2020 [85] | Phase 1, open label, dose-escalating and safety trial using a 3 + 3+3 design | Not yet recruiting | 9 18 years and older |
Mesenchymal Stromal cells | Participant number with Treatment-Related Adverse effects. | |
| Fairbairn et al. 2020 [86] | Phase 1/2 Randomized, Placebo-Controlled Trial | Not yet recruiting | 70 18-85 years |
ACT-20-MSC | Placebo (MEM-α) | Mortality at day 30 |
| Sender et al. 2020 [[87]] | Phase 1b Randomized, Double-Blind, Placebo-Controlled Study | Not yet recruiting | 45 18-80 years |
BM-Allo.MSC | Placebo (plasmalyte and human albumin) | Incidence of AEs, mortality and its cause and Number of ventilator-free days |
| Rave et al. 2020 [88] | Phase I/II Study of Human Placental Hematopoietic stem cells Derived Natural Killer cells | Recruiting | 86 18 years and older |
CYNK-001 | Number and severity of adverse events for Phase 1 and Time to Clearance of SARS-CoV-2 for Phase 2 | |
| Hill et al. 2020 [89] | Early Phase 1 | Not yet recruiting | 30 18 years and older |
Mesenchymal Stromal cells | Incidence of unexpected adverse events and Improved oxygen saturations ≥93 % | |
| Barbado et al. 2020 [90] | Double Blind, Placebo-controlled, Phase II Trial | Recruiting | 24 18 years and older |
Allogenic Mesenchymal Stromal cells MSV | Placebo | Proportion of patients who have achieved withdrawal of invasive mechanical ventilation |
| Wang et al. 2020 [91] | Phase 2 | Recruiting | 16 18-80 years |
UC-MSCs | Oxygenation index | |
| Monsel et al. 2020 [92] | Phase1/2 | Recruiting | 40 18 years and older |
umbilical cord Wharton's jelly-derived mesenchymal stromal cells | NaCl 0.9 % | Efficacy in respiration |
| [93] | Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study | Recruiting | 140 40-80 years |
allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells (PLX-PAD) | Placebo solution for injection | Number of ventilator free days |
| Ting et al. 2020 [94] | Phase 2/3 Study | Recruiting | 400 18-89 years old |
MultiStem | Placebo intravenous infusion |
Ventilator-Free Days. Safety and tolerability |
| Miller et al. 2020 [95] | Multi-center, Randomized, Sham Controlled, Double-blind, Ascending-dose Study | Not yet recruiting | 24 18 years and older |
SBI-101 (device containing allogeneic hMSC’s + FDA-approved plasmapheresis device) | Sham device containing no MSCs | Safety and tolerability |
| Qu et al. 2020 (96) | Pilot Clinical Study | Not yet recruiting | 30 18−75 years |
Aerosol Inhalation of the Exosomes Derived from Allogenic Adipose Mesenchymal stem cells | Time to clinical improvement and safety |