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

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud4 sites in 1 country16 target enrollmentOctober 2013

ConditionsFaecal Incontinence

InterventionsInfusion of mesenchymal stem cells from adipose tissue Infusion of placebo

DrugsInfusion of mesenchymal stem cells from adipose tissue

Overview

Phase: Phase 1
Intervention: Infusion of mesenchymal stem cells from adipose tissue
Conditions: Faecal Incontinence
Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Enrollment: 16
Locations: 4
Primary Endpoint: Number of Serious Adverse Events
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

September 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males or females in the age group of 18-80 yrs.
•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).
•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.
•Duration of faecal incontinence of at least two years prior to inclusion.
•Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent.

Exclusion Criteria

•More of an external sphincter defect and / or at any level of internal anal canal.
•Have received treatment to faecal failure with bulking agents, neuromodulation or surgery.
•Current anorectal tumors.
•Current anal fissures.
•Anorectal stenosis
•Chronic pelvic or anorectal pain.
•Pregnant or 6 months postpartum.
•Medical history of infection with Human Immunodeficiency Virus (HIV) or any severe immunocompromised state or therapy immunosuppressive.
•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.
•Bleeding diathesis or current anticoagulant therapy.