Clinical trial NCT02292628: Study, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence
Official title: Study Phase I/II, Double Blind, Randomized, Comparing Two Groups to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells From Adipose Tissue (CMMAd) in the Treatment of the Faecal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Faecal Incontinence
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Iniciativa Andaluza en Terapias Avanzadas
First posted: 2014-11-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Males or females in the age group of 18-80 yrs.
2. A unique internal sphincter defect and / or external (no more than 100 º), at any level of the anal canal, of any cause (except those described in the exclusion criteria).
3. Severity of faecal incontinence of 12 or more in the Wexner Score and / or at least six episodes of faecal incontinence for a period of 28 days.
4. Duration of faecal incontinence of at least two years prior to inclusion.
5. Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent.

Exclusion Criteria:

1. More of an external sphincter defect and / or at any level of internal anal canal.
2. Have received treatment to faecal failure with bulking agents, neuromodulation or surgery.
3. Current anorectal tumors.
4. Current anal fissures.
5. Anorectal stenosis
6. Chronic pelvic or anorectal pain.
7. Pregnant or 6 months postpartum.
8. Medical history of infection with Human Immunodeficiency Virus (HIV) or any severe immunocompromised state or therapy immunosuppressive.
9. Malignancies in remission for less than a year before the study. An exception to the basocellular carcinoma (BCC) in "remission" for less than a year.
10. Bleeding diathesis or current anticoagulant therapy.
11. Chemotherapy during the 6 months preceding the study.
12. Previous radiation with evidence of radiation injury in the treated area.
13. Participation in any other clinical study during the 3 months preceding the pre-study visit.
14. Patients with other serious disorders.
15. Patients with uncontrolled inflammatory disease or taking drugs prohibited in the protocol or active perianal disease.

Primary outcomes:
measure: Number of Serious Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Changes in the faecal incontinence diary
timeFrame: 12 months
measure: Anorectal manometry
timeFrame: 12 months
measure: Jorge-Wexner Score
timeFrame: 12 months
measure: Faecal Incontinence Quality of Life
timeFrame: 12 months
Other outcomes:
Locations:
city: Huelva
country: Spain
facility: H. Juan Ramón Jiménez
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Málaga
country: Spain
facility: Hospital Regional U de Málaga
city: Sevilla
country: Spain
facility: Hospital U Virgen del Rocio
Study officials:
affiliation: Hospital U. Virgen del Rocio
name: Fernando de la Portilla, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Regional U de Málaga
name: Santiago Mera, Dr.
role: PRINCIPAL_INVESTIGATOR
References: