Skeletal muscle-derived cell implantation for the treatment of sphincter-related faecal incontinence

Table 1 Patient demographics and baseline characteristics (V-2), N = 39 (ITT)

Characteristic	Value
Age (years), mean (SD)	60.6 (13.81)
Height (cm), mean (SD)	166.3 (6.82)
Weight (kg), mean (SD)	68.5 (14.53)
BMI (kg/m²), mean (SD)	24.7 (4.21)
Gender, n (%)
Female	34 (87.2)
Male	5 (12.8)
History of anorectal surgeries (including anal sphincter surgery)^a, n (%)	2 (5.13)
FI episodes
Time since first diagnosis (months), mean (SD)	128.3 (109.96)
Cause of FI^b,c, n (%)
Muscle damage only	16 (41.03)
Atrophy only	17 (43.59)
Both	6 (15.38)
CGI score by investigator^d
Moderately ill	2 (5.1)
Markedly ill	14 (35.9)
Severely ill	17 (43.6)
Among the most extremely ill	6 (15.4)

V-2 3 months pre implantation, N number of values, ITT intention to treat, SD standard deviation, BMI body mass index, n number of patients, FI faecal incontinence, CGI Clinical Global Impression
^aEarlier than 6 months before screening and no more than two surgeries (otherwise not included)
^bMultiple answers possible
^cAccording to medical history, in none of the patients was FI associated with constipation, diarrhoea, pelvic floor dysfunction, nerve damage or loss of storage capacity
^dCGI scores: normal, not at all ill, borderline mentally ill, mildly ill, moderately ill, markedly ill, severely ill, among the most extremely ill patients [38]

ISSN: 1757-6512