Clinical trial to evaluate the safety in the treatment of fecal incontinence with stem cells.

Phase I / II, multicenter, double blind, randomized, comparison of two groups and two doses, to evaluate the safety and efficacy of autologous ASCs in the treatment of fecal incontinence.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021659-17-ES

Enrollment

Unknown

Registered

2013-05-16

Start date

2013-08-14

Completion date

Unknown

Last updated

2017-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with incontinence faecal MedDRA version: 16.0 Level: LLT Classification code 10056118 Term: Incontinence faecal System Organ Class: 100000004856

Interventions

Product Name: Células mesenquimales de tejido adiposo Product Code: CMMTa Pharmaceutical Form: Suspension for injection INN or Proposed INN: células mesenquimales de tejido adiposo CAS Number: NA Curr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years, male or female 2. A unique internal sphincter defect and / or external, at any level of the anal canal, from any cause (except those described in the exclusion criteria). 3. Severity of fecal incontinence of 7 or more in the Wexner Score and / or at least six episodes of fecal incontinence for a period of 28 days, reported in the Journal of Patient *. 4. Duration of faecal incontinence of at least two years prior to inclusion. 5. Written informed consent obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: 1.More an external sphincter defect and / or at any level of the internal anal canal. 2.Have treated with faecal bulking agents, neuromodulation or surgery. 3. Chronic pelvic pain 4. Pregnant or 6 months postpartum. 5. Medical history of infection with HIV

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and feasibility of therapy with autologous mesenchymal stem cells.;Secondary Objective: To evaluate efficacy of therapy with autologous mesenchymal stem cells in the treatment of fecal incontinence structural. This change will be measured at 6 and 12 months from baseline in the following variables: number of fecal incontinence episodes of loose stools or solid (according to the patient's daily defecation), and FIQL Wexner score (scale quality of life of fecal incontinence).;Primary end point(s): Severity of incontinence, regarding quality of life of faecal incontinence (FIQL) anal manometry, adverse events.;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: To evaluate the safety and feasibility of therapy with autologous mesenchymal stem cells.;Secondary Objective: To evaluate efficacy of therapy with autologous mesenchymal stem cells in the treatment of fecal incontinence structural. This change will be measured at 6 and 12 months from baseline in the following variables: number of fecal incontinence episodes of loose stools or solid (according to the patient's daily defecation), and FIQL Wexner score (scale quality of life of fecal incontinence).;Primary end point(s): Severity of incontinence, regarding quality of life of faecal incontinence (FIQL) anal manometry, adverse events.;Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): Not available;Timepoint(s) of evaluation of this end point: Not available	—

Countries

Spain

Contacts

Public ContactAna Cardesa Gil

Fundación Pública Andaluza Progreso y Salud

ana.cardesa@juntadeandalucia.es0034955019040NA

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026