Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2017-10-31

Brief Summary

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

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Detailed Description

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

Conditions

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Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ASC + fibrin glue

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.

Group Type EXPERIMENTAL

◦Drug: ASCs. + fibrin glue

Intervention Type DRUG

Experimental group

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.

Group Type ACTIVE_COMPARATOR

fibrin glue

Intervention Type DRUG

•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive

Interventions

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◦Drug: ASCs. + fibrin glue

Experimental group

Intervention Type DRUG

fibrin glue

•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive

Intervention Type DRUG

Other Intervention Names

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Experimental Drug: ASCs + fibrin glue

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No