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

Primary Purpose

Anal Fistula

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
◦Drug: ASCs. + fibrin glue
fibrin glue
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula focused on measuring phase III, Adipose derived stem cells, Anal fistula, Cell therapy, Stem cell therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Clínico Lozano Blesa
  • Hospital Clínico Universitario
  • Hospital General Universitario
  • Hospital Universitario La Paz
  • Clínica Universitaria de Navarra

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ASC + fibrin glue

Fibrin glue

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 ]

Secondary Outcome Measures

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 ]

Full Information

First Posted
March 1, 2013
Last Updated
April 17, 2018
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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1. Study Identification

Unique Protocol Identification Number
NCT01803347
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
Keywords
phase III, Adipose derived stem cells, Anal fistula, Cell therapy, Stem cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASC + fibrin glue
Arm Type
Experimental
Arm Description
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.
Arm Title
Fibrin glue
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
◦Drug: ASCs. + fibrin glue
Other Intervention Name(s)
Experimental Drug: ASCs + fibrin glue
Intervention Description
Experimental group
Intervention Type
Drug
Intervention Name(s)
fibrin glue
Intervention Description
•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive
Primary Outcome Measure Information:
Title
Safety/efficacy
Description
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 ]
Time Frame
2014, march
Secondary Outcome Measure Information:
Title
Safety/efficacy
Description
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 ]
Time Frame
2015, march

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signature of informed consent. 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. Patients of both genders, with more that 18 years. Good overall health, according to data from the clinical history and physical examination. Exclusion Criteria: Patient diagnosed with inflammatory bowel disease. 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. History of alcohol or substance abuse in the 6 months prior to inclusion. 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. medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study. Subjects with congenital or acquired immunodeficiencies. Treponema, Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion. Major surgery or severe trauma of the subject in the previous semester. Pregnant or lactating women. Adult women of childbearing potential not using effective contraception during the trial. Administration of any investigational drug at present to three months prior to enrollment for this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damián García-Olmo, Prof.
Organizational Affiliation
Instituto de Investigación Hospital Universitario La Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Lozano Blesa
City
Zaragoza
State/Province
Aragón
ZIP/Postal Code
59009
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Salamanca
State/Province
Castilla-Leon
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital General Universitario
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23053677
Citation
de la Portilla F, Alba F, Garcia-Olmo D, Herrerias JM, Gonzalez 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.
Results Reference
result
PubMed Identifier
22065114
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):595-600. doi: 10.1007/s00384-011-1350-1. Epub 2011 Nov 9.
Results Reference
result
PubMed Identifier
20636801
Citation
Garcia-Arranz M, Gomez-Pinedo U, Hardisson D, Herreros D, Guadalajara H, Garcia-Gomez I, Garcia-Verdugo JM, Garcia-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. No abstract available.
Results Reference
result
PubMed Identifier
19273960
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 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487.
Results Reference
result
PubMed Identifier
18694359
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.
Results Reference
result
PubMed Identifier
15933795
Citation
Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-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. doi: 10.1007/s10350-005-0052-6.
Results Reference
result

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Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

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