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

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ClinicalTrials.gov Identifier: NCT01803347
Recruitment Status : Completed
First Posted : March 4, 2013
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary:
Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery

Condition or disease Intervention/treatment Phase
Anal Fistula Drug: ◦Drug: ASCs. + fibrin glue Drug: fibrin glue Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : February 2013
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Safety/efficacy [ Time Frame: 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 Outcome Measures :
  1. Safety/efficacy [ Time Frame: 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 ]



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803347


Locations
Spain
Hospital Clínico Lozano Blesa
Zaragoza, Aragón, Spain, 59009
Hospital Clínico Universitario
Salamanca, Castilla-Leon, Spain, 37007
Hospital General Universitario
Valencia, Comunidad Valenciana, Spain, 46014
Hospital Universitario La Paz
Madrid, Spain, 28046
Clínica Universitaria de Navarra
Pamplona, Spain, 31008
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Investigators
Principal Investigator: Damián García-Olmo, Prof. Instituto de Investigación Hospital Universitario La Paz

Publications of Results:

Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT01803347     History of Changes
Other Study ID Numbers: 2012-001178-28
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: March 2017

Keywords provided by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz:
phase III
Adipose derived stem cells
Anal fistula
Cell therapy
Stem cell therapy

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants