Faecal incontinence (FI) in women with obstetric anal sphincter injury Digestive System
Conditions
Interventions
Advanced therapy medicinal product – cell-based
ASMDC-PLGA microcarriers [Poly(DL-lactide-co-glycolide) (PLGA) microcarriers combined with autologous skeletal muscle cells (ASMDC), derived from the sk
Sponsors
University College London
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged =18 years 2. Chronic faecal incontinence 3. History of obstetric external anal sphincter injury 4. Non-surgical treatments for faecal incontinence have been attempted to applicable national standards 5. Minimum severity: 8 faecal incontinence or urgency episodes in 4-week screening period, with a minimum of 4 episodes of faecal incontinence
Exclusion criteria
Exclusion criteria: 1. Patients within 1 year of acute sphincter injury 2. Patients who have undergone previous anal reconstructive surgery 3. Other gastro-intestinal diseases (see protocol for details) 4. Pregnancy or intent to become pregnant during trial 5. Morbid obesity (BMI =35 kg/m2) 6. Certain comorbidities (recent history of cancer, systemic neuromuscular and connective tissue diseases, transmissible viral infection) 7. Patient currently using sacral neuromodulation (SNM) or has failed SNM implant for faecal incontinence; failed test stimulation phase is permitted 8. Patient has positive virology or parasitology results (Hepatitis B, C & E, HIV 1 & 2, syphilis, human T-lymphotropic virus I or II, Epstein-Barr virus, Cytomegalovirus, Toxoplasma gondii, Trypanosoma cruzi, West Nile Virus or malaria) confirmed, where appropriate, using local testing policies. Note T. cruzi, malaria and West Nile Virus tests only required if relevant participant history criteria met.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The incidence of ATIMP-related or ATIMP administration procedure-related adverse events associated with the use of ASMDC-PLGA microcarriers within 12 months post-treatment (safety endpoint of primary hypothesis and outcome is reported at 12 months) 2. Estimate of a minimum clinically relevant reduction in the frequency of total FI episodes measured using participant bowel diaries at 12 months compared to baseline levels | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life assessed using patient questionnaires: Resource Use Measure, EQ-5D-5L, mean cost of healthcare resource use per patient 2. Additional clinical efficacy outcomes will be assessed using patient questionnaires: St Mark’s Incontinence Score; Likert scale of patient’s global impression of treatment success; Short-Form Bowel Symptom Importance Questionnaire (SF-BSIQ); Measure Yourself Medical Outcome Profile All secondary outcome measures are evaluated at baseline (visit 3), and 3 and 6 months after treatment (visit 9 and 10). Where patients take part in extended follow-up, data collection will take place at visits 11 and 12 (12 and 18 months after treatment). Exceptions: Likert scale not evaluated at visit 3 EQ-5D-5L collected at visit 6 (day of treatment). Resource Use Measure not collected at visit 9 (3 months) | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed