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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