Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

Brief Summary

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.”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: March 2014

Detailed Clinical Trial Description

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

Interventions Used in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 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.
  • Active Comparator: 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Safety/efficacy
    • Time Frame: 2014, march
      Safety Issue?: Yes
  • safety/efficacy
    • Time Frame: 2014, march
      Safety Issue?: No

Secondary Measures

  • Safety/efficacy
    • Time Frame: 2015, march
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Instituto de Investigación Hospital Universitario La Paz
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Damián García-Olmo, Prof., Principal Investigator, Instituto de Investigación Hospital Universitario La Paz

Citations Reporting on Results

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. Int J Colorectal Dis. 2013 Mar;28(3):313-23. doi: 10.1007/s00384-012-1581-9. Epub 2012 Sep 29.

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):595-600. doi: 10.1007/s00384-011-1350-1. Epub 2011 Nov 9.

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. 2010 Jun;56(7):979-82. doi: 10.1111/j.1365-2559.2010.03573.x.

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 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487.

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.

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.


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