Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells (FISPAC)

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status and phase: Completed; Phase 3

Conditions: Anal Fistula

Treatments: Drug: fibrin glue; Drug: ◦Drug: ASCs. + fibrin glue

Study type: Interventional

Funder types: Other

Identifiers

NCT01803347

2012-001178-28

Details and patient eligibility

About

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

Full description

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

ASC + fibrin glue

Experimental group

Description:

Intervention: drug: ASC + fibrin glue Experimental: ASCs+fibrin glue: Subjects will be treated with a dose of 100 million ASCs plus fibrin glue plus a deep curettage and closure of the internal orifice and evaluated after 16 weeks. If needed a second dose of 100 million ASCs plus fibrin glue will be applied then.

Treatment:

Drug: ◦Drug: ASCs. + fibrin glue

Fibrin glue

Active Comparator group

Description:

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.

Treatment:

Drug: fibrin glue