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Table 4 Selected clinical trials of MSCs-based therapy for PFDs

From: MSC-based therapy in female pelvic floor disorders

Author/year Conditions Number of patients MSC sources Harvesting tissue Method of injection/number of cells Follow-up Clinical evaluation Clinical outcomes Adverse events
Kuismanen et al. 2014 [96] SUI 5 Autologous ADSCs Abdominal subcutaneous adipose tissue Transurethral/2.5 × 106to 8.5 × 106 12 months Cough test; 24-h pad test; questionnaires The cough test was negative for three patients; questionnaire scores improved Small hematomas
Carr et al. 2013 [94] SUI (not improved with conservative therapy) 38 AMDCs Quadriceps femoris Intrasphincter/low doses (1, 2, 4, 8, 16 × 106) or high doses (32, 64, 128 × 106) 18 months 3-day voiding diaries; 24-hour pad test; questionnaires The mean pad weight and mean leakage frequency reduced; better outcomes in high dose vs the low dose group; questionnaire scores improved Urinary tract infection
Peters et al. 2014 [95] SUI (refractory to prior treatment) 80 AMDCs Quadriceps femoris Intrasphincter/10, 50, 100, 200 × 106 12 months 3-day voiding diaries; 24-hour pad tests; questionnaires The diary leakage frequency reduced within 1 to 3 months; only patients who received 200 × 106 cells had a reduction in mean pad weight; questionnaire scores improved Biopsy related adverse
Sèbe et al. 2010 [91] SUI with fixed urethra (after previous failed surgical management) 12 AMDCs Deltoid muscle Endourethral/1 × 107, 2.5 × 107, and 5 × 107 12 months 7-days bladder diary; 1-h pad test; questionnaires Pad tests were negative for three patients; two patients were slightly worsened; questionnaire scores improved Three cases of urinary tract infection
Stangel-Wojcikiewicz et al. 2014 [92] SUI of degrees I or II 16 AMDCs Deltoid muscle Transurethral/0.6 × 106to 5 × 106 2 years Cough LLP; Valsalva LLP; urodynamic studies; questionnaires Continent (50%), some improvement (25%), no improvement (25%) No severe adverse effects
Stangel-Wojcikiewicz et al. 2016 [93] SUI of degrees I or II 16 AMDCs Deltoid muscle Transurethral/0.6 × 106 to 25 × 106 4 years I-QOL questionnaire The total I-QOL score increased from 49 before therapy to 77 2 years post-operation No severe adverse effects
Arjmand et al. 2017 [97] SUI (6 combined with POP) 10 Autologous ADSCs Abdominal subcutaneous adipose tissue Periurethral/1.18 × 107 24 weeks 24 h voiding diary; 24-h pad test; urodynamics and uroflow studies; ICIQ questionnaire Pad test weight and ICIQ scores were improved; maximum flow rate improved. one case of slight voiding difficulty
Frudinger et al. 2018 [98] FI 39 (34 females and 5 males) AMDCs Musculus pectoralis major Injected into the external anal sphincter/15 × 107 12 months Weekly incontinence episodes (WIE); Incontinence diary; Wexner scores; anorectal manometry tests In 79.5% of patients, the WIE frequency had decreased by at least 50%. No severe adverse effects
Sarveazad et al. 2017 [99] FI (after sphincteroplasty) 20 Autologous ADSCs Superficial abdominal fat tissue Injected into the external anal sphincter/6 × 107 8 weeks Wexner scores; endorectal sonography; electromyography (EMG) Ratio of the area occupied by the muscle to total area of the lesion increased; no difference in Wexner scores between the groups one case of erythema at the site of surgery
Jankowski et al. 2018 [100] SUI 143 AMDCs Vastus lateralis Intrasphincter/15 × 107 2 years Incontinence episode frequency (IEF); 24-h or in-office pad weight tests; questionnaires Responder rates for the endpoint were similar between groups; with the stringent endpoint, a relationship was between IQOL scores and the responder rates No severe adverse effects
  1. SUI stress urinary incontinence, FI fecal incontinence, AMDCs autologous muscle derived cells, ADSCs derived MSCs, ADSCs adipose-derived stem cells, LLP leak-point pressure, I-QOL incontinence quality of life scale, ICIQ international consultation on incontinence questionnaire