Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

Phase 3

Completed

• Conditions: Anal Fistula
• Interventions: Drug: fibrin glue

• Registration Number: NCT01803347
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary

Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

Detailed Description

Study of efficacy of adipose derived mesenchimals stem cells and surgery to treat complex perianal fistula

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-01
• Study First Posted: 2013-03-04
• Status Verified: 2017-03
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2018-04-17
• Last Update Posted: 2018-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Signature of informed consent.

2. Complex perianal fistula cryptoglandular. Understood as a fistula in which at least one of the following circumstances is present:

   • some degree of fecal incontinence associated
   • extrasphinterics fistulas,
   • fistulas supraresfinterianas
   • high transsphincteric fistulas.

3. Patients of both genders, with more that 18 years.

4. Good overall health, according to data from the clinical history and physical examination.

Exclusion Criteria

1. Patient diagnosed with inflammatory bowel disease.
2. Subjects with abscess, except if a complete cleaning of the drainage area of collections is performed and the absence of abscess and other collections larger than 2 cm in maximum diameter before treatment is started is confirmed.
3. History of alcohol or substance abuse in the 6 months prior to inclusion.
4. Malignancy, except in the case of basal cell carcinoma or squamous cell skin or a history of malignancy, unless they have been found in remission during the previous 5 years.
5. medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study.
6. Subjects with congenital or acquired immunodeficiencies. Treponema, Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion.
7. Major surgery or severe trauma of the subject in the previous semester.
8. Pregnant or lactating women.
9. Adult women of childbearing potential not using effective contraception during the trial.
10. Administration of any investigational drug at present to three months prior to enrollment for this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrin glue	fibrin glue	Intervention: fibrin glue Fibrin glue: Subjects will be treated with a dose fibrin glue plus a deep curettage and closure of the internal orifice, and evaluated after 16 weeks. If needed a second dose of fibrin glue will be applied then.

Primary Outcome Measures

Name	Time	Method
Safety/efficacy	2014, march	Closure of fistulas defined as absence of suppuration and re-epithelization of the external opening and absence of collections\>2 cm directly related to the fistula tract treated, as measured by MRI (healing) \[ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose \]

Secondary Outcome Measures

Name	Time	Method
Safety/efficacy	2015, march	Clinical complexity of fistula (complexity of fistula score) • Safety: Cumulative incidence of adverse effects. • Quality of life (SF-36 score) • Degree of anal incontinence (Wexner incontinence score) \[ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose \]

Trial Locations

Locations (5)

Hospital Clínico Lozano Blesa; 🇪🇸 Zaragoza, Aragón, Spain

Hospital Clínico Universitario; 🇪🇸 Salamanca, Castilla-Leon, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital General Universitario; 🇪🇸 Valencia, Comunidad Valenciana, Spain

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Spain