Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

Anal Fistula Clinical Trial

— FISPAC  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803347
• Other study ID #: 2012-001178-28
• Status: Completed
• Phase: Phase 3
• First received: March 1, 2013
• Last updated: April 17, 2018
• Start date: February 2013
• Est. completion date: October 2017

Study information

• Verified date: March 2017
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Drug:
• ?Drug: ASCs. + fibrin glue
Experimental group
• fibrin glue
•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid
Spain	Clínica Universitaria de Navarra	Pamplona
Spain	Hospital Clínico Universitario	Salamanca	Castilla-Leon
Spain	Hospital General Universitario	Valencia	Comunidad Valenciana
Spain	Hospital Clínico Lozano Blesa	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

References & Publications (6)

de la Portilla F, Alba F, García-Olmo D, Herrerías JM, González FX, Galindo A. Expanded allogeneic adipose-derived stem cells (eASCs) for the treatment of complex perianal fistula in Crohn's disease: results from a multicenter phase I/IIa clinical trial. — View Citation

García-Arranz M, Gómez-Pinedo U, Hardisson D, Herreros D, Guadalajara H, García-Gómez I, García-Verdugo JM, García-Olmo D. Histopathological analysis of human specimens removed from the injection area of expanded adipose-derived stem cells. Histopathology — View Citation

García-Olmo D, García-Arranz M, Herreros D, Pascual I, Peiro C, Rodríguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. — View Citation

Garcia-Olmo D, Garcia-Arranz M, Herreros D. Expanded adipose-derived stem cells for the treatment of complex perianal fistula including Crohn's disease. Expert Opin Biol Ther. 2008 Sep;8(9):1417-23. doi: 10.1517/14712598.8.9.1417 . Review. — View Citation

Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 J — View Citation

Guadalajara H, Herreros D, De-La-Quintana P, Trebol J, Garcia-Arranz M, Garcia-Olmo D. Long-term follow-up of patients undergoing adipose-derived adult stem cell administration to treat complex perianal fistulas. Int J Colorectal Dis. 2012 May;27(5):595-6 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety/efficacy	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 ]	2014, march
Secondary	Safety/efficacy	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 ]	2015, march