Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

Multicentre,Randomized,Comparative,Add-on,Into Two Parallel Groups Clinical Trial to Evaluate Efficacy and Safety of Autologous Mesenchymal Stem Cells Derived From Expanded Adipose Tissue (ASC), for Treatment of Complex Perianal Fistulizing Disease in Patients Without IBD.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01803347

Acronym

FISPAC

Enrollment

Registered

2013-03-04

Start date

2013-02-28

Completion date

2017-10-31

Last updated

2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistula

Keywords

phase III, Adipose derived stem cells, Anal fistula, Cell therapy, Stem cell therapy

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

Interventions

DRUG◦Drug: ASCs. + fibrin glue

Experimental group

DRUGfibrin glue

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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) \[ Time Frame: weeks 1, 4, 12 and 16. Week 28 in patients with a second dose \]

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026