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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Instituto de Investigación Hospital Universitario La Paz
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier:
NCT01803347
First received: March 1, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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


Condition Intervention Phase
Anal Fistula
Drug: ◦Drug: ASCs. + fibrin glue
Drug: fibrin glue
Phase 3

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
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.

Resource links provided by NLM:


Further study details as provided by Instituto de Investigación Hospital Universitario La Paz:

Primary Outcome Measures:
  • Safety/efficacy [ Time Frame: 2014, march ] [ Designated as safety issue: Yes ]
    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 ]

  • safety/efficacy [ Time Frame: 2014, march ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Safety/efficacy [ Time Frame: 2015, march ] [ Designated as safety issue: Yes ]
    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 ]


Estimated Enrollment: 80
Study Start Date: February 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: ◦Drug: ASCs. + fibrin glue
Experimental group
Other Name: Experimental Drug: ASCs + fibrin glue
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.
Drug: fibrin glue
•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803347

Locations
Spain
Hospital Clínico Lozano Blesa Recruiting
Zaragoza, Aragón, Spain, 59009
Contact: José Antonio Gracia Solanas, Dr    0034 976 76 57 00      
Hospital Clínico Universitario Recruiting
Salamanca, Castilla-Leon, Spain, 37007
Contact: Jacinto García-García, Dr    0034 923291634      
Sub-Investigator: Consuelo Cañizo, Dr         
Sub-Investigator: Olga López         
Hospital General Universitario Recruiting
Valencia, Comunidad Valenciana, Spain, 46014
Contact: José Vicente Roig, Dr    0034 961 972 000    roig_jvi@gva.es   
Hospital Universitario La Paz Recruiting
Madrid, Spain, 28046
Contact: Damián García-Olmo, Prof    0034 912071022    damian.garcia@uam.es   
Sub-Investigator: Héctor Guadalajara, Dr         
Sub-Investigator: Dolores Herreros-Marcos, Dr         
Sub-Investigator: Mariano García-Arranz, Dr         
Sub-Investigator: Paloma De La Quintana         
Clínica Universitaria de Navarra Recruiting
Pamplona, Spain, 31008
Contact: Jorge Baixauli, Dr    0034 948255400    jbaixauli@unav.es   
Sub-Investigator: Felipe Prosper, Dr         
Sub-Investigator: Enrique Andreu, Dr         
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
Principal Investigator: Damián García-Olmo, Prof. Instituto de Investigación Hospital Universitario La Paz
  More Information

Publications:

Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01803347     History of Changes
Other Study ID Numbers: 2012-001178-28
Study First Received: March 1, 2013
Last Updated: March 1, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
United States: Food and Drug Administration

Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
phase III
Adipose derived stem cells
Anal fistula
Cell therapy
Stem cell therapy

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical
Fibrin Tissue Adhesive
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014