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

Faecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292628
• Other study ID #: CMMAd/InFe/2011
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 6, 2014
• Last updated: April 16, 2018
• Start date: October 2013
• Est. completion date: September 2017

Study information

• Verified date: April 2018
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Faecal Incontinence
• Fecal Incontinence

Intervention

Drug:
• Infusion of mesenchymal stem cells from adipose tissue

Other:
• Infusion of placebo

Locations

Country	Name	City	State
Spain	H. Juan Ramón Jiménez	Huelva
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital Regional U de Málaga	Málaga
Spain	Hospital U Virgen del Rocio	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud	Iniciativa Andaluza en Terapias Avanzadas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Serious Adverse Events		12 months
Secondary	Changes in the faecal incontinence diary		12 months
Secondary	Anorectal manometry		12 months
Secondary	Jorge-Wexner Score		12 months
Secondary	Faecal Incontinence Quality of Life		12 months