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

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Status and phase: Completed; Phase 2; Phase 1

Conditions: Faecal Incontinence

Treatments: Other: Infusion of placebo; Drug: Infusion of mesenchymal stem cells from adipose tissue

Study type: Interventional

Funder types: Other

Identifiers

NCT02292628

CMMAd/InFe/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

Mesenchymal stem cells

Experimental group

Description:

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

Treatment:

Drug: Infusion of mesenchymal stem cells from adipose tissue

Ringer lactate solution

Placebo Comparator group

Description:

Ringer lactate solution

Treatment:

Other: Infusion of placebo