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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02292628

Enrollment

Registered

2014-11-17

Start date

2013-10-31

Completion date

2017-09-30

Last updated

2018-04-17

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

Conditions

Faecal Incontinence

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.

Interventions

DRUGInfusion of mesenchymal stem cells from adipose tissue

OTHERInfusion of placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of Serious Adverse Events	12 months

Secondary

Measure	Time frame
Changes in the faecal incontinence diary	12 months
Anorectal manometry	12 months
Jorge-Wexner Score	12 months
Faecal Incontinence Quality of Life	12 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026