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Table 3 Ongoing clinical trials using MSCs and MSC-derived exosomes to treat COVID-19 patients

From: Potential application of mesenchymal stem cells and their exosomes in lung injury: an emerging therapeutic option for COVID-19 patients

Clinical trial identifier Study design Phase Intervention/treatment Dose and route of administration Estimated enrollment Control group Country Recruitment status
NCT04348461# RCT, parallel assignment, multicenter, quadruple* masking 2 Allogeneic AT-MSCs Two doses of 1.5 × 106/kg, IV 100 (50 each group) Standard of care Spain Not yet recruiting
NCT04467047 Interventional, open label 1 Allogenic BM-MSCs 1 × 106 MSCs/kg, IV 10 None Brazil Not yet recruiting
NCT04473170 RCT, open-label 1/2 Autologous NHPBSCs Dose: non specified, jet nebulization 146 Standard care UAE Completed
NCT04349540 Prospective non-interventional study NA Allogenic hematopoietic stem cells Not defined 40 None UK Active, not recruiting
ChiCTR2000029990# Pilot trial, interventional study 2 MSCs (undefined source) 1 × 106 per kg of weight, IV 7 patients for MSC transplant and 3 for placebo Vehicle placebo China Recruiting
NCT04466098 Interventional, randomized, placebo-controlled, parallel assignment, triple masking (participant, care provider, investigator) 2 MSCs (undefined source) 300 × 106 MSCs, three fixed doses of MSCs, approximately 48 h apart, IV 30 randomized (2:1 ratio) placebo-controlled trial. Vehicle placebo (Dextran 40 + 5% human serum albumin) USA Recruiting
NCT04445220 Interventional, randomized, placebo-controlled, parallel assignment, quadruple masking (participant, care provider, investigator) 1/2 Allogeneic human MSCs (undefined source) Low dose cohort: SBI-101 device containing 250 million MSCs; high dose cohort: SBI-101 device containing 750 million MSCs, extracorporeal 24 Sham device containing no MSCs USA Not yet recruiting
NCT04447833 Single group assignment, open label 1 Allogeneic BM-MSCs First three patients receive a single dose of 1 × 106 MSCs/kg dose, next six patients receive a single dose of 2 × 106 MSCs/kg, IV 9 N.A. Sweden Recruiting
NCT04457609 RCT, parallel assignment, triple* 1 Allogenic UC-MSCs Intravenous infusion of 1 × 106 unit of UC-MSCs/kg BW in 100 cc of 0.9% NaCl for 1 h, in addition to standardized treatment (oseltamivir and azithromycin) 40 Placebo (oseltamivir and azithromycin) Indonesia Recruiting
NCT04397471 Observational, prospective N.A Allogenic BM-MSCs Not defined 10 N.A. UK Not yet recruiting
NCT04461925 Non-randomized, parallel, open label 1/2 Allogenic placenta-derived MSCs 1 million cells/kg body weight/time, once every 3 days for a total of 3 times: day “1”, day “4”, day “7”, IV + ceftriaxone, azithromycin, anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies 30 Ceftriaxone, azithromycin, anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies Ukraine Recruiting
NCT04428801 RCT, double* masking 2 Autologous AT-MSCs (Celltex-AdMSCs) 200 million every 3 days (3 doses), IV 200 Placebo (not defined) USA Not yet recruiting
NCT04416139 Non-randomized, parallel assignment, open label 2 MSCs (undefined source/from bank) 1 million/kg in a single dose, IV 10 Standard management measures Mexico Recruiting
NCT04429763 RCT, parallel design, triple* masking 2 Allogenic UC-MSCs 1 × 106 cells/kg single dose, IV 30 Placebo (not defined) Colombia Not yet recruiting
NCT04444271 Interventional, RCT, parallel design, open label 2 Autologous BM-MSCs 2 × 106 cells/kg on days 1 and 7 (if needed), IV 20
(20 each group)
Placebo (100 ml normal saline IV) Pakistan Recruiting
NCT04456361 Interventional, single group assignment, open label 1 WJUC-MSCs Single-dose of 1 × 108 cells, IV 9 N.A. Mexico Active, not recruiting
NCT04366271 Randomized, interventional, parallel design, open label 2 Allogeneic UC-MSCs Single IV infusion MSCs (dose unspecified) + standard of care 106 N.A. Spain Recruiting
NCT04371393 RCT, parallel design, triple* masking 3 Allogenic BM-MSCs (Remestemcel-L) + standard of care Two doses of 2 × 106 MSC/kg (doses 4 days apart ± 1 day), IV+ standard of care 300 (150 each group) Placebo (Plasma-Lyte + standard of care) USA Recruiting
NCT04313322 Interventional, prospective, single group, open-label. 1 Allogenic WJ-MSCs Three doses of 1 × 106/kg, 3 days apart, IV 5 N.A. Jordan Recruiting
NCT04452097 Interventional, prospective, single group, open-label. 1 UC-MSC 0.5 million cells/kg, IV, plus standard treatment 9 N.A NA Not yet recruiting
NCT04315987 RCT, quadruple* masking 2 NestCell® + standard of care Four doses of 2 × 106/kg, at days 1, 3, 5, and 7, IV 90 (45 each group) Placebo (undefined) Brazil Not yet recruiting
NCT04252118 (preliminary for NCT04288102) Interventional, prospective, non-randomized, parallel assignment, open-label 1 Allogenic UC-MSCs + conventional treatment Three doses of 3.0 × 107 at days 0, 3, and 6 20 (10 patients in each arm) Conventional treatment China Recruiting
NCT04288102 RCT, quadruple* masking 2 Allogenic UC-MSCs + conventional treatment Three doses of 4 × 107, at days 0, 3, 6, IV + standard of care 90 (60 patients assigned to treatment and 30 to control group) Placebo (saline containing 1% human serum albumin) China Completed
NCT04302519 Interventional, prospective, non-randomized, single group, open-label 1 Dental pulp MSCs + conventional treatment Three doses of 1.0 × 106 cells/kg, at days 1, 3, and 7, IV 24 N.A. Shanghai Not yet recruiting
NCT04273646 RCT, parallel assignment, open label N.A. Allogenic UC-MSCs + conventional treatment Four doses of 5.0 × 106 cells/kg at, days 1, 3, 5, and 7, IV+ conventional treatment 48 (24 patients in each arm) Placebo + conventional treatment China Not yet recruiting
NCT04299152 Prospective, two-arm, partially masked/single masking (care provider). 2 Preconditioned CB-MSC (patient mononuclear cells) N.A. 20 Conventional treatment China Not yet recruiting
NCT04269525 Interventional, prospective non-randomized, single group assignment, open-label. 2 Allogenic UC-MSCs Four doses of 3.3 × 107cells at, days 1, 3, 5, and 7, IV 10 N.A. China Recruiting
NCT04333368 Interventional, RCT, parallel assignment, triple* masking 1/2 Allogenic WJUC-MSCs + standard of care Three doses of 1.0 × 106 cells/kg at days 1, 3, and 5, IV 40 (20 treated, 20 placebos) Placebo (NaCl 0.9%) + standard of care France Recruiting
NCT04276987 Interventional, prospective, single group assignment, open-label 1 Allogeneic AT-MSCs-Exo + conventional treatment Five doses of 2.0 × 108 nanovesicles, days 1, 2, 3, 4, and 5, aerosol inhalation route 30 N.A. China Completed
NCT04336254 Interventional, RCT, triple* masking 1/2 Allogeneic human dental pulp MSCs Three doses of 3.0 × 107 cells/dose at, days 1, 4 and 7, IV 20 Placebo (3 ml 0.9% saline) China. Recruiting
NCT04348435 RCT, double-blinded 2 Allogeneic AT-MSCs (HB-adMSCs) Five doses of either 2 × 108, 1 × 108 or 5 × 107 cells/single doses at weeks 0, 2, 6, 10, and 14, IV 100 Placebo (saline) USA Enrolling by invitation
NCT04352803 Non-randomized, sequential assignment, open-label 1 Autologous AT-MSCs 5 × 105/kg, IV 20 N.A. N.A. Not yet Recruiting
NCT04366323 RCT, parallel assignment open-label 1/2 Allogeneic AT-MSCs Two doses of 8 × 107 cell/dose, IV 26 No intervention Spain Recruiting
NCT04349631 Interventional, single group assignment, open-label 2 Autologous AT-MSCs Five doses of cells (unspecified dose), IV 56 No USA Enrolling by invitation
NCT04346368 RCT, single masking (participant). 1/2 BM-MSCs + conventional treatment Single dose 1 × 106 MSCs/kg, IV 20 Placebo + conventional treatment China Not yet recruiting
NCT04382547 Non-randomized, parallel assignment, open label 1/2 Allogeneic Om-MSCs + conventional treatment Doses N.A., IV 40 Conventional treatment Belarus Enrolling by invitation
NCT04366063 RCT, parallel assignment, open-label 2/3 MSCs (undefined source) and EV-MSCs + conventional treatment Intervention group 1: two doses 1 × 108 at day 0, 2, IV
Intervention group 2: two doses 1 × 108 at day 0, 2 + EVs at days 4, 6, IV
60 (20 into two intervention groups, 20 control) Conventional treatment Iran Recruiting
NCT04437823 Randomized, parallel assignment 2 UC-MSCs 5 × 105 UCMSCs per kg, IV on days 1, 3 and 5 besides the standard care (SOC) 20 SOC Pakistan Recruiting
NCT04339660 RCT, triple* masking 1/2 Allogeneic UC-MSCs One-two doses of 1 × 106/kg (1 week apart), IV 30 (15 each group) Placebo (saline) China Recruiting
NCT04392778 Interventional, RCT quadruple* masking 1/2 Allogeneic UC-MSCs Three doses of 3 × 106 cells/kg on days 0, 3, and 6, IV 30 (10 each group) Placebo (saline) Turkey Recruiting
NCT04371601 RCT, Open-label 1 Allogeneic UC-MSCs + oseltamivir Four single doses of 1 × 106/kg, 4 days apart, IV + Oseltamivir 60 Oseltamivir China Active, not recruiting
NCT04355728 RCT, parallel assignment, double blinded, 1/2 Allogeneic UC-MSCs as add-on therapy + standard of care Two doses of 100 × 106 cells, IV 24 (12 each group) Standard of care USA Recruiting
NCT04362189 RCT, quadruple* masking 2 Allogeneic AT-MSCs Four doses of 1.0 × 108 cells at days 0, 3, 7, and 10, IV 100 (50 each group) Placebo (saline) USA Not yet recruiting
NCT04390152 RCT, quadruple* masking 1/2 Allogeneic WJ-MSCs + standard of care Two doses of 50 × 106, IV 40 Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy) Colombia Not yet recruiting
NCT04377334 Randomized, parallel assignment, Open-label 2 Allogeneic BM-MSCs N.A. 40 (20 each group). No intervention. Germany Not yet recruiting
NCT04331613 Interventional, open-label 1/2 Human embryonic stem cell-derived M cells (CAStem) Doses of 3, 5, or 106 cells/kg, route not specified 9 N.A China Recruiting
NCT04390139 RCT, quadruple* masking 1/2 WJ-MSCs + standard of care Two doses, 1 × 106 cells/kg, IV 30 (15 to each group) Placebo + standard of care Spain Recruiting
NCT04400032 Interventional, non-randomized, sequential assignment, open-label 1 BM-MSCs (undefined source) Intervention group 1: three doses 25 × 106 at day 0, 1, 3 IV
Intervention group 2: three doses 50 × 106 at day 0, 1, 3 IV
Intervention group 3: three doses 90 × 106 at day 0, 1, 3, IV
9 N.A. Canada Not yet recruiting
NCT04398303 RCT, double* masking 1/2 Allogeneic WJ-MSCs and WJ-MSC-CM Intervention group 1: 1.0 × 106//kg cells in 100 ml CM+ Conventional treatment
Intervention group 2: 100 ml CM+ conventional treatment
70 Conventional treatment |+placebo USA Not yet recruiting
NCT04365101 RCT, open-label 1/2 Natural killer (NK) cells derived from human placental CD34+ cells CYNK-001 infusions on days 1, 4, and 7 86 (1:1 randomization ratio) Best supportive care USA Recruiting
NCT04393415 Randomized, parallel, double masking N.A. Allogeneic UC-MSCs UC-MSC (undefined dose) + platelet rich plasma (PRP) 100 PRP. Egypt Not yet recruiting
NCT04397796 RCT, quadruple* masking 1 Allogeneic BM-MSCs Undefined dose and route 45 Placebo (plasmalyte and albumin) USA Not yet recruiting
NCT03042143 RCT, quadruple*masking 1/2 Allogeneic WJ-MSCs (CD362 enriched) Single dose of 4 × 108 cells, IV 75 Placebo (plasmalyte) UK Recruiting
NCT04345601 Single group, parallel assignment, open-label 1 Allogeneic BM-MSCs Single dose of 1X108 cells, IV 30 Standard of care USA Not yet recruiting
NCT04361942 RCT, Triple*masking 2 Allogeneic MSCs Single dose of 1 × 106 cells/kg, IV 24 Placebo (saline) Spain Recruiting
NCT04333368 RCT, Triple*masking 1/2 Allogeneic WJ-MSCs Three doses of 1 × 106 cells/kg at days 1, 3, and 5, IV 40 (20 each group) Placebo (0.9% saline) France  
NCT04389450 RCT, quadruple* masking 2 Allogeneic PLX-PAD High and low doses groups (cell dose unspecified), 1 week apart, IM 140 Placebo USA Recruiting
NCT04367077 RCT, sequential assignment, quadruple* masking 2/3 BM-MSCs (MultiStem), source unspecified Dose unspecified, IV 400 Placebo USA Recruiting
  1. #Trial with published results, and withdrawn trials were excluded from the table
  2. ChiCTR Chinese Clinical Trial Registry; NCTnumber ClinicalTrials.gov identifier; RCT Randomized control trial; Triple* masking participant, investigator, outcomes assessor; Double* masking participant, outcomes assessor; MSCs mesenchymal stem cells; NHPBSC non-hematopoietic peripheral blood stem cells; Remestemcel-L third-party/allogenic bone marrow of unrelated and human leukocyte antigen (HLA)-unmatched healthy adult donors; NestCell® MSC therapy produced by Cellavita; SBI-101 therapy extracorporeal mesenchymal stromal cell therapy; SBI-101 a biologic/device combination product that combines two components: allogeneic human MSCs and an FDA-approved plasmapheresis device; AT-MSCs adipose tissue mesenchymal stem cells; EV-MSCs extracellular vesicles derived from MSCs; WJUC-MSCs Wharton’s jelly of umbilical cords mesenchymal stem cells; UC-MSCs umbilical cord mesenchymal stem cells; CB-MSC cord blood MSC; AT-MSCs-Exo exosomes derived from allogeneic AT-MSCs; Om-MSCs olfactory mucosa MSCs; CM conditioned media; PLX-PAD placental mesenchymal-like adherent stromal cells; IV intravenous; IM intramuscular; N.A. not applicable