NCT02292628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

3.9 years

First QC Date

November 6, 2014

Last Update Submit

April 16, 2018

Conditions

Faecal Incontinence

Outcome Measures

Primary Outcomes (1)

  • Number of Serious Adverse Events

    12 months

Secondary Outcomes (4)

  • Changes in the faecal incontinence diary

    12 months

  • Anorectal manometry

    12 months

  • Jorge-Wexner Score

    12 months

  • Faecal Incontinence Quality of Life

    12 months

Study Arms (2)

Mesenchymal stem cells

EXPERIMENTAL

Autologous mesenchymal stem cells from the adipose tissue in an unique intralesional infusion with a dose of 40 million cells.

Drug: Infusion of mesenchymal stem cells from adipose tissue

Ringer lactate solution

PLACEBO COMPARATOR

Ringer lactate solution

Other: Infusion of placebo

Interventions

Infusion of mesenchymal stem cells from adipose tissueDRUG
Mesenchymal stem cells
Infusion of placeboOTHER
Ringer lactate solution

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females in the age group of 18-80 yrs.

You may not qualify if:

  • 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.
  • Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent.
  • 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.
  • Chemotherapy during the 6 months preceding the study.
  • Previous radiation with evidence of radiation injury in the treated area.
  • Participation in any other clinical study during the 3 months preceding the pre-study visit.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

H. Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Regional U de Málaga

Málaga, 29010, Spain

Location

Hospital U Virgen del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Study Officials

  • Fernando de la Portilla, Dr.

    Hospital U. Virgen del Rocio

    PRINCIPAL INVESTIGATOR

  • Santiago Mera, Dr.

    Hospital Regional U de Málaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2014

First Posted

November 17, 2014

Study Start

October 1, 2013

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

ES(4)