Stem cell therapy for faecal incontinence: Current state and future perspectives

Table 5 Overview of published clinical experience in stem cell therapy for faecal incontinence

Ref.	Study type	N	Stem cell	Treat-ment	Compared	Other treatments	Effect measure	F-U	Principal results
[102]	Phase II RCT	26	AUT ASCs	Injection fistula	Fibrin glue	No	Subjective	1 yr	Improvement 60% vs 23%
[68]	Obser-vational	10	AUT MB	Injection EAS	No	Anal electrical estimulation 10 + 4 wk	Clinical MAR Morphology	1 yr	↓ Wexner and episodes 1 yr, ↑QoL ↑ Voluntary P 1, 6 mo no at 12 Morphology no changes
[69]	Obser-vational	=						5 yr	↓ Wexner and episodes, ↑QoL ↑ P
[70]	Case report	1	AUT MB	Injection EAS	No	No	Clinical MAR + EMG	1 yr	Improved since 6 wk ↑ P and EMG on scar area
[71]	Obser-vational	10	AUT MB	Injection EAS	No	No	Clinical MAR	1 yr	MAR SS 18 wk Clinical: 66% 18 wk and 44.4% 1 yr EMG improvement all F-U
[72]	RCT double-blind	18	ALLO ASCs	Injection EAS	PBS	Surgery	Wexner US EMG	2 mo	No differences on Wexner ↑ SS muscle area and EMG
[73]	Phase II RCT	24	AUT MB	Injection EAS	Placebo	Biofeedback 15 d	Wexner, FIQL MAR, NPS US, MRI	1 yr	SS improve wexner 1 yr, response 60% Partial improvement FIQL 6-12 mo No morphologic differences at 12 mo Transient placebo effect

AUT: Autologous; ALLO: Allogeneic; RCT: Randomized controlled trial; MB: Myoblast; NPS: Neurophysiology; SS: Statistically significant; QoL: Quality of life; P: Pressure; F-U: Follow-up.