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

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.

Study Overview

• Status: Completed
• Conditions: Faecal Incontinence
• Intervention / Treatment: Drug: Infusion of mesenchymal stem cells from adipose tissue; Other: Infusion of placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Huelva, Spain, 21005
    • H. Juan Ramón Jimenez
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz
  • Málaga, Spain, 29010
    • Hospital Regional U de Málaga
  • Sevilla, Spain, 41013
    • Hospital U Virgen del Rocio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mesenchymal stem cells; 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
Placebo Comparator: Ringer lactate solution	Other: Infusion of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Serious Adverse Events	12 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Collaborators: Iniciativa Andaluza en Terapias Avanzadas
• Investigators: Principal Investigator: Fernando de la Portilla, Dr., Hospital U. Virgen del Rocio; Principal Investigator: Santiago Mera, Dr., Hospital Regional U de Málaga

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: November 6, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence
• Other Study ID Numbers: CMMAd/InFe/2011