This is a clinical trial phase I/II, double blind, randomized to compare in two groups of patients to evaluate the safety and efficacy of the autologous mesenchymal stem cells from the adipose tissue (CMMAd) in the treatment of the faecal incontinence.
In the phase of recruitment, of 20 months of duration, there will be included 16 participants who will be randomized to one of the groups of intervention (8 patients group CMMAd / 8 patients group placebo). The phase of follow-up of every patient will be 12 months, though, provided that these patients are seen regularly in the study sites of the study, once concluded his follow-up will be continued to be able to obtain safety information and efficacy to 24 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
16
H. Juan Ramón Jiménez
Huelva, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital Regional U de Málaga
Málaga, Spain
Hospital U Virgen del Rocio
Seville, Spain
Number of Serious Adverse Events
Time frame: 12 months
Changes in the faecal incontinence diary
Time frame: 12 months
Anorectal manometry
Time frame: 12 months
Jorge-Wexner Score
Time frame: 12 months
Faecal Incontinence Quality of Life
Time frame: 12 months
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