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

• Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud (Other)
• Overall Status: Completed
• CT.gov ID: NCT02292628
• Collaborator: Iniciativa Andaluza en Terapias Avanzadas (Other)
• Enrollment: 16
• Locations: 4
• Arms: 2
• Duration (Months): 47
• Patients Per Site: 4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Faecal Incontinence	Drug: Infusion of mesenchymal stem cells from adipose tissue; Other: Infusion of placebo	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

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 Ringer lactate solution	Other: Infusion of placebo

Outcome Measures

Primary Outcome Measures

1. Number of Serious Adverse Events [12 months]

Secondary Outcome Measures

1. Changes in the faecal incontinence diary [12 months]

2. Anorectal manometry [12 months]

3. Jorge-Wexner Score [12 months]

4. Faecal Incontinence Quality of Life [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H. Juan Ramón Jiménez	Huelva		Spain	21005
2	Fundación Jiménez Díaz	Madrid		Spain	28040
3	Hospital Regional U de Málaga	Málaga		Spain	29010
4	Hospital U Virgen del Rocio	Sevilla		Spain	41013

Sponsors and Collaborators

• Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• ClinicalTrials.gov Identifier: NCT02292628
• Other Study ID Numbers: CMMAd/InFe/2011
• First Posted: Nov 17, 2014
• Last Update Posted: Apr 17, 2018
• Last Verified: Apr 1, 2018

• Additional relevant MeSH terms: Fecal Incontinence

Study Results

No Results Posted as of Apr 17, 2018