TABLE 10.
PRECLINICAL IN VIVO STUDIES | ||||||||||
Type of advanced therapy | Cells | Type of hMSC treatment evaluated | Animals | Disease models | Follow-up | References | ||||
Cell therapy | hAT-MSCs | 1-hAT-MSCs group: subcutaneous injection of 106 cells 2-Stromal vascular fraction (SVF) group subcutaneous injection of SVF containing 106 hAT-MSCs 3-Control group: subcutaneous injection of phosphate buffered saline | 30 Athymic Nude-Foxn1nu (10 mice per group) | Human skin samples were grafted into mice for 7 weeks to develop hypertrophic scars | 21 days | Domergue et al., 2016 | ||||
hBM-MSCs | 1-hBM-MSCs group: addition to the wound of 106 cells/ml 2-hBM-MSCs + collagen I-tenascin-C (TNC) group: addition to the wound of 106 cells/ml + collagen I-tenascin-C (TNC) 3-hBM-MSCs + fibroblasts + hyaluronic acid (HA) group: addition to the wound of 106 cells/ml + fibroblasts + HA 4-hBM-MSCs + fibroblasts + collagen I-TNC + hyaluronic acid (HA) group: addition to the wound of 106 cells/ml + fibroblasts + collagen I-TNC + HA | – C57BL/6J wild-type and CXCR3 expression-abrogated mice | Wounds these mice presented a visible scar, a thickened epidermis, and a disorganized and hypercellular dermis | 30 days | Yates et al., 2017 | |||||
CLINICAL STUDIES | ||||||||||
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 | Allogenic hUCB-MSCs | Phase II Randomized Clinical Trial (Parallel Assignment- Triple Blind) | 90 (0/90) | 28.04 ± 3.39 | A transdermal application of 106 cells for continuous 3 days (low-dose) or for continuous 6 days (high-dose) or placebo | No obvious side effects or adverse effects were reported | Caesarean Section Scars | Vancouver Scar Scale (VSS) score after 6 months was lower in the case of the high-dose group against low-dose and placebo groups (4.71, 5.18 and 6.43, respectively) | 6 months and 36 months | Fan et al., 2018; Fan et al., 2020 NCT02772289 (Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars – Full Text View – ClinicalTrials.gov)1 NCT04034615 (Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients – Full Text View – ClinicalTrials.gov)2 |
aExpression of measures: mean ± standard deviation (range).
1Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars – Full Text View – ClinicalTrials.gov Available at: https://clinicaltrials.gov/ct2/show/NCT02772289 [Accessed February 14, 2021].
2Injection of Autologous Adipose-derived Stromal Vascular Fraction in the Finger of Systemic Sclerosis Patients – Full Text View – ClinicalTrials.gov Available at: https://clinicaltrials.gov/ct2/show/NCT03060551 [Accessed February 14, 2021].