Table 4 Clinical trials using mesenchymal stem cells in MS patients
From: Paving the way towards an effective treatment for multiple sclerosis: advances in cell therapy
Source of cells | Years | Country | Phase | NCT number | Type of study | MS type | n | EDSS | Route of administ | Dose of MSCss | Number of administrations | Immunological findings | Ref |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
aMSCs | 2013 | Italy | I/II | NCT01854957 | Randomized, double-blind, placebo-compared | Active PPMS, SPMS, RRMS | 185 | 2.5–6.5 | i.v. | A dose of 1–2 × 106 MSCs/kg body weight | Single | Unreported | |
aMSCs | 2013–2016 | UK | I/II | NCT01606215 | |||||||||
aMSCs | 2014–2018 | Canada | II | NCT02239393 | |||||||||
aBM-MSCs | 2015–2018 | France | I/II | NCT02403947 | |||||||||
aBM-MSCs | 2013–2016 | Spain | I/II | NCT02035514 | |||||||||
aADMSCs | 2012–2015 | Sweden | I/II | NCT01730547 | |||||||||
aMSCs | 2011–2018 | Iran | I/II | NCT01377870 | Randomized, double-blind, placebo-compared | RRMS, SPMS, RRMS | 22 | 3–6.5 | i.v. | Unreported | Single | Unreported | Unpublished |
aMSCs | 2010–2014 | Spain | II | NCT01228266 | Randomized, double-blind, placebo-controlled, crossover | RRMS | 9 | 3–6.5 | i.v | A dose of 1–2 × 106 MSCs/kg body weight | Single | Non significative decrease of Th1 and Th17 cells; increase of Breg | |
aMSCs | 2011–2016 | USA | I | NCT00813969 | Open-label | RRMS, SPMS | 24 | 3–6.5 | i.v. | A dose of 2 × 106 MSCs/kg body weight | Single | Unreported | |
aBM-MSCs | 2014–2016 | Israel | II | NCT02166021 | Randomized, double-blind, placebo-compared | PPMS, SPMS | 48 | 3.5–6.5 | i.t. and i.v. | 10 × 106/mL to 15 × 106/mL | Double | Unreported | Unpublished |
aBM-MSCs | 2006–2011 | UK | I/II | NCT00395200 | Open-label | SPMS | 10 | 2–6.5 | i.v. | A dose of 2 × 106 MSCs/kg body weight | Single | Unreported | |
aBM-MSCs | 2013–2017 | Jordan | II | NCT01895439 | Open-label | MS | 13 | ≤6 | i.t. | Unreported | Unreported | Unreported | Unpublished |
aBM-MSCs | 2006–2009 | Israel | I/II | NCT00781872 | Open-safety clinical trial | Active MS and ALS | 15 MS and 19 ALS | 4–8 | i.t. and i.v. | 60 × 106 i.t. (n = 34) and 25 × 106 i.v. (n = 14) | Single | Increase of Treg (CD4+ CD25+) and decrease of CD83+ and CD86+ on DC and activated CD40+ cells. Decrease of in vitro lymphocytes proliferation to PHA | |
aBM-MSCs | 2017 | Jordan | I | NCT03069170 | Open-label | RRMS | 50 | 3–6.5 | i.t. and i.v. | Unreported | Single | Recruiting IgG, IgA, and IgM levels and complement factors C3 and C4 will be analysed | Unpublished |
aBM-MSCs | 2015–2017 | India | I/II | NCT02418351 | Open-label | RRMS | 69 | 3.5–6.5 | i.t. and i.v. | 50 × 106 BM-MNC (i.v.) and 100 × 106 BM-MNCs i.t. (when associated with CCSVI) | Single | Unreported | Unpublished |
alloUCMSCs | 2015–2017 | Trinidad and Tobago | I/II | NCT02418325 | Open-label | RRMS | 69 | 3.5–6.5 | i.t. and i.v. | 50 × 106 UC-MSCs (i.v.) and 100 × 106 UC-MSCs i.t. (when associated with CCSVI) | Single | Unreported | Unpublished |
aBM-MSCs | 2015–2018 | Spain | I/II | NCT02495766 | Quadruple-blind, placebo-controlled study | RRMS and SPMS | 8 | <6.5 | i.v. | Unreported | Single | Unreported | Unpublished |
aBM-MSCs | 2014–2018 | UK | II | NCT01815632 | Double-blind, placebo-controlled study | SPMS and PPMS | 80 | 4–6 | i.v. | 500–600 mL bone marrow | single | Unreported | |
aBM-MSCs | 2013–2018 | UK | II | NCT01932593 | Double-blind, placebo-controlled study | SPMS and PPMS | 6 | 4–6 | i.v. | 500–600 mL bone marrow | Reinfusion (extension of NCT01815632) | Unreported | |
aADMSCs | 2010–2015 | Spain | I/II | NCT01056471 | Triple-blind, placebo-controlled study | SPMS | 30 [11 placebo, 10 low-dose and 9 high-dose] | 5.5–9 | i.v. | Low-dose (1 × 106 cells/kg) or high-dose (4 × 106 cells/kg) | Single | Unreported | |
aADMSCs | 2014–2018 | German | I | NCT02326935 | Open-label | MS patients | 2 | Unreported | i.v. | 150 × 106 cells | Single | Unreported | Unpublished |
aASVF | 2014–2018 | USA | II | NCT02157064 | Open-label | MS patients | 221 | Unreported | Unreported | Unreported | Unreported | Unreported | Unpublished |
alloUCMSCs | 2014–2017 | Panama | I/II | NCT02034188 | Open-label | MS patients | 20 | 2–5.5 | i.v. | Infusions of 20 × 106 UCMSCs over 7 days | 7 doses | Unreported | |
alloUCMSCs | 2010–2014 | China | I/II | NCT01364246 | Open-label | Progressive MS and NMO | 20 | Unreported | Unreported | Unreported | Unreported | Unreported | Unpublished |
alloUCMSCs | 2017 | Jordan | I/II | NCT03326505 | Randomized, single-blind | MS patients | 60 | ≤7 | i.t. | Unreported | Single | Unreported | Unpublished |
