Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
ConditionFecal Incontinence
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInnovacell GmbH
About this trial
The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must be at least 18 years old
Patients who are mentally competent and able to understand all study requirements
Female patients of childbearing potential willing to use appropriate methods of contraception
Patient has symptoms of urge fecal incontinence with a disease duration of at least 6 months and did not improve sufficiently by conservative treatment performed for at least 3 months
Disqualifiers
Patients for whom the investigator determines that FI has a different cause than external anal sphincter dysfunction.
Patients with global fragmentation of the external anal sphincter as assessed by anal canal ultrasound
Patients who underwent any anorectal surgery within 6 months before screening visit
Patients who underwent a total of two or more external anal sphincter-related surgeries
Trial design
Design model
Parallel
Treatments tested in this trial
aSMDC
Biological/VaccineAutologous Muscle Derived Cells for injection into the external anal sphincter
Placebo
Other interventionPlacebo control is the vehicle solution used for the study product
Treatment groups
290 Participants
are divided into 2 treatment groupsGroup A: aSMDCExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in frequency of incontinence episodes
Urge fecal incontinence
Time frame
12 MonthsSponsors and contacts
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Source ClinicalTrials.gov