TABLE 7.
Clinical studies of hMSCs used as advanced therapy for psoriasis in the last 5 years.
| Type of advanced therapy | Cells | Type of clinical study | N (male/female) | Age (years)a | hMSC treatment | Safety (Treatment-related adverse events) | Indication | Effectivenessa | Follow-upa | References |
| Cell therapy | Allogeneic hUCB-MSCs | Case report | 2 (1/1) | 30.5 ± 6.4 | 1–3 infusions of hUCB-MSCs (106 cells/kg) | None | Psoriasis vulgaris | No symptoms of psoriatic relapse were observed | 4–5 years | Chen et al., 2016 |
| Autologous hAT-MSCs | Case report | 2 (1/1) | 43 ± 21.2 | 2–3 intravenous infusions of hAT MSCs at a dose of 0.5 –3.1 × 106 cells/kg | None | Psoriasis vulgaris (PV) and psoriatic arthritis (PA) | PASI changed from 21 to 9 and from 24 to 8.3 | 0.63 years | De Jesus et al., 2016 | |
| Autologous hAT-MSCs | Case report | 1 (1/0) | 43 | Intravenous injection of 3 – 6 × 107 hAT-MSCs in normal saline | None | Severe psoriasis | PASI score decreased from 50.4 to 0.3 | 1 year | Comella et al., 2018 | |
| Allogeneic hG-MSCs | Case report | 1 (1/0) | 19 | 5 bolus injections of hG-MSCs (3 × 106/kg/infusion) | None | Plaque psoriasis | After 3 years the disease was resolved | 3 years | Wang et al., 2020 | |
| Allogeneic hUCB-MSCs | Early Phase I clinical trial (Single Group Assignment- Open Label) | 12 | (18–65) | Different doses of hUCB-MSCs from 1.5 × 106 to 3 × 106 | – | Psoriasis vulgaris | – | 6 months | NCT03765957 (Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells – Full Text View – ClinicalTrials.gov)1 | |
| Allogeneic hAT-MSCs | Phase I/II Clinical Trial (Single Group Assignment- Open Label) | 7 | (18–65) | Intravenous injection of 5 × 105 cells/kg at week 0, week 4 and week 8 | – | Moderate to severe psoriasis | – | 12 weeks | NCT03265613 (Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis – Full Text View – ClinicalTrials.gov)4 | |
| Allogeneic hAT-MSCs | Phase I/II Clinical Trial (Single Group Assignment- Open Label) | 5 | Intravenous injection of 2 × 106 cells/kg at week 0, week 2, week 4, week 6 and week 8. In addition, calcipotriol ointment was topically applied twice daily | – | Moderate to severe psoriasis | – | 12 weeks | NCT03392311 (Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis – Full Text View – ClinicalTrials.gov)3 | ||
| Allogeneic hAT-MSCs | Clinical Trial (Single Group Assignment- Open Label) | 8 | (18–65) | Intravenous injection of 2 × 106 cells/kg at week 0, week 2, week 4, week 6 and week 8. In addition, oral PSORI-CM01 Granule plus calcipotriol ointment was topically applied twice daily | – | Moderate to severe psoriasis | – | 12 weeks | NCT04275024 (Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients – Full Text View – ClinicalTrials.gov)2 | |
| Allogeneic hUCB-MSCs | Phase I Clinical Trial (Single Group Assignment- Open Label) | 9 | (19–65) | Different doses of hUCB-MSCs from 5 × 107 to 2 × 108, subcutaneously injected | – | Moderate to severe plaque psoriasis | – | 144 weeks | NCT02918123 (Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis – Full Text View – ClinicalTrials.gov)5 |
aExpression of measures: mean ± standard deviation (range).
1Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells – Full Text View – ClinicalTrials.gov Available at: https://www.clinicaltrials.gov/ct2/show/NCT03765957?term=mesenchymal+stem+cells&recrs=abdefgh&cond=Psoriasis&strd_s=01%2F01%2F2015&strd_e=12%2F31%2F2020&draw=2&rank=1 [Accessed January 13, 2021].
2Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients – Full Text View – ClinicalTrials.gov Available at: https://www.clinicaltrials.gov/ct2/show/NCT04275024?term=mesenchymal+stem+cells&recrs=abdefgh&cond=Psoriasis&strd_s=01%2F01%2F2015&strd_e=12%2F31%2F2020&draw=1&rank=4 [Accessed January 21, 2021].
3Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis – Full Text View – ClinicalTrials.gov Available at: https://www.clinicaltrials.gov/ct2/show/NCT03392311?term=mesenchymal+stem+cells&recrs=abdefgh&cond=Psoriasis&strd_s=01%2F01%2F2015&strd_e=12%2F31%2F2020&draw=1&rank=3 [Accessed January 21, 2021].
4Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis – Full Text View – ClinicalTrials.gov Available at: https://www.clinicaltrials.gov/ct2/show/NCT03265613?term=mesenchymal+stem+cells&recrs=abdefgh&cond=Psoriasis&strd_s=01%2F01%2F2015&strd_e=12%2F31%2F2020&draw=2&rank=2 [Accessed January 21, 2021].
5Safety of FURESTEM-CD Inj. in Patients With Moderate to Severe Plaque-type Psoriasis – Full Text View – ClinicalTrials.gov Available at: https://www.clinicaltrials.gov/ct2/show/NCT02918123?term=mesenchymal+stem+cells&recrs=abdefgh&cond=Psoriasis&strd_s=01%2F01%2F2015&strd_e=12%2F31%2F2020&draw=1&rank=5 [Accessed January 21, 2021].