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Anal FistulaPhase 3FISPACNCT01803347

Clinical Trial to Evaluate the Efficacy and Safety of Stem Cells

A Phase 3 study testing ◦Drug: ASCs. + fibrin glue and fibrin glue in people with Anal Fistula, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 5 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Efficacy of treatment of perianal fistula with mesenchymal stem cells and surgery Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anal Fistula
What is being tested?
◦Drug: ASCs. + fibrin glue and fibrin glue
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
5 sitesSpain
Study dates
Feb 2013to Oct 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clínica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Clínico Universitario

    Salamanca, Castille and León, 37007

  • Hospital General Universitario

    Valencia, Valencia, 46014

  • Hospital Clínico Lozano Blesa

    Zaragoza, Aragon, 59009

Other trials in Spain

About this study

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

Read the detailed description

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

Conditions
Anal Fistula
Being tested
◦Drug: ASCs. + fibrin glue, fibrin glue
Keywords
phase III, Adipose derived stem cells, Anal fistula, Cell therapy, Stem cell therapy
Medical subject headings
Rectal Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ◦Drug: ASCs. + fibrin glueDrug

    Also called Experimental Drug: ASCs + fibrin glue

    Experimental group

  • fibrin glueDrug

    •Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive

Study groups in NCT01803347
Study groupRoleWhat they receive
ASC + fibrin glueExperimentalIntervention: 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.
Receives: Drug: ◦Drug: ASCs. + fibrin glue
Fibrin glueActive comparatorIntervention: 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.
Receives: Drug: fibrin glue

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 ]

    Measured: 2014, march

Secondary outcomes (1)

  1. 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 ]

    Measured: 2015, march

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01803347
Sponsor's protocol ID
2012-001178-28
Acronym
FISPAC
Status last verified
Mar 2017
First submitted
1 Mar 2013
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23053677

  • 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.

    PubMed 22065114

  • 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.

    PubMed 20636801

  • 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.

    PubMed 19273960

  • 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.

    PubMed 18694359

  • 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.

    PubMed 15933795

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ◦Drug: ASCs. + fibrin glue and fibrin glue in people with Anal Fistula, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 5 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety/efficacy (time frame: 2014, march). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01803347, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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