Table 3 Ongoing clinical trials using MSCs and MSC-derived exosomes to treat 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 |