Research Article

Efficacy and Safety of Mesenchymal Stem Cell Transplantation in the Treatment of Autoimmune Diseases (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Inflammatory Bowel Disease, Multiple Sclerosis, and Ankylosing Spondylitis): A Systematic Review and Meta-Analysis of Randomized Controlled Trial

Table 1

The characteristics of the included studies.

DiseaseStudyTrial registration numberCountrySample size (female/male)InterventionDosageRoute of medicationRelevant outcomesMean age (years)Disease duration (years)Duration
Trial groupControl groupTrial groupControl groupTrial groupControl groupTrial groupControl group

Rheumatoid arthritisYang et al. 2018 [29]ChiCTR-ONC-16008770China52 (40/12)53 (43/10)MSC injection1% albumin in physiological saline as the treatment or 50 mL of 1% albumin in normal saline without UCMSCs cells/kgIntravenous infusionDisease activity, adverse eventsResponse: 50.7; nonresponse: 51.249.8Response: ; nonresponse: 48 weeks
Shadmanfar et al. 2018 [30]NCT01873625Iran13 (13/0)15 (13/2)MSC injectionNormal salineNot knownIntra-articular injectionDisease activity, adverse events48 weeks
Álvaro-Gracia et al. 2017 [31]NCT01663116Spain46 (42/4)7 (6/1)MSC injectionRinger’s lactate solution cell or 210^7 cell or 310^7 cellIntravenous infusionDisease activity, adverse events24 weeks
Systemic lupus erythematosusTang et al. 2016 [32]China12 (11/1)MSC injection+prednisolone+cyclophosphamide+mycophenolatePrednisolone+cyclophosphamide+mycophenolate cellsIntravenous infusionSystemic lupus erythematosus disease activity index (SLEDAI), urine protein, adverse events19-440.2-1424 weeks
Zeng et al. 2016 [33]China7 (not known)8 (not known)MSC injection+glucocorticoid+mycophenolate mofetilGlucocorticoid+mycophenolate mofetil cellsRenal arterySLEDAI, urine protein, C348 weeks
Deng et al. 2017 [34]NCT01539902China12 (11/1)6 (6/0)MSC injectionPlacebo cellsIntravenous infusionSLEDAI, urine protein, C3, adverse events48 weeks
Yang et al. 2014 [35]China17 (15/2)20 (20/0)MSC injection+glucocorticoid+cyclophosphamideGlucocorticoid+cyclophosphamide cellsIntravenous infusionSLEDAI, urine protein, C3, adverse events48 weeks
Inflammatory bowel diseaseHu et al. 2016 [36]NCT01221428China34 (13/21)36 (14/22)Mesenchymal stem cell (MSC) infusions twice besides the base treatment with a 7 day intervalNormal saline infusions twice besides the base treatment with a 7-day interval cellIntravenous infusionClinical efficacy (based on Mayo scores), Mayo score and IBDQ score, adverse events24 weeks
Garcia-Olmo et al. 2009 [37]Spain14 (11/3)Adipose-derived stem cells+fibrin glueFibrin glue only cell/mLLocal injectionClinical efficacy (healing of a complex perianal fistula), quality of life score (SF-12), adverse events8 weeks
Panés et al. 2016 [38]NCT01541579Seven European countries and Israel107(47/60)105(49/56)MSC injectionNormal saline injection cellLocal injectionClinical efficacy, adverse events24 weeks
Molendijk et al. 2015 [39]NCT01144962Netherlands15 (6/9)6 (3/3)MSC injectionNormal saline+human albumin injection cell or cell or cellLocal injectionClinical efficacy (healing of a perianal fistula), adverse events21-5427-495-281-2012 weeks
Ankylosing spondylitisSu et al. 2020 [40]China20(8/12)20(7/13)MSC injectionFliximab injection cells/kgIntravenous infusionClinical efficacy, immune index, and adverse events24 weeks
Multiple sclerosisJi et al. 2013 [41]China60 (39/19)MSC injection+rituximabGlucocorticoid cellsIntravenous infusion and oralProgression-free survival (PFS) rate, number of episodes, ability of daily living (ADL) scale, number of lesion, volume of lesion (cm3), adverse events96 weeks
Fernández et al. 2018 [42]NCT01056471Spain19 (13/6)11 (8/3)MSC injection low and high doseRinger’s lactate cells/kg or 410^6 cells/kgIntravenous infusionExpanded disability status scale (EDSS), number of lesion, volume of lesion (cm^3), adverse eventsLow dose: 44.8 ± 8.0; high dose: 47.8 ± 9.746.3 ± 8.9Low dose: 15.4 ± 6.1; high dose: 18.7 ± 8.718.9 ± 7.324 weeks
Petrou et al. 2020 [43]NCT02166021Israel32 (16/16)16(4/12)MSC injectionNormal saline cells/kgIntrathecal injection or intravenous infusionEDSS, adverse eventsIntravenous infusion: ; intrathecal injection: Intravenous infusion: ; intrathecal injection: 24 weeks
Li et al. 2014 [44]China13 (9/4)10 (7/3)MSC injectionNo normal saline cells/kgIntravenous infusionEDSS, cytokine6 weeks
Lublin et al. 2014 [45]The United States and Canada12(9/3)4 (2/2)MSC injectionPlacebo cells or cellsIntravenous infusionEDSS, adverse events36-5840-5248 weeks
Llufriu et al. 2014 [46]NCT01228266Spain9(7/2)MSC injectionSuspension media cells/kgIntravenous infusionEDSS, number of lesion, volume of lesion (cm3), adverse events24 weeks