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AzTrials

Anal FistulaPhase 3FATT1NCT00475410

Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease

A Phase 3 study testing ASCs (Cx401, company code) and Fibrin adhesive in people with Anal Fistula, run by Tigenix S.A.U. at 10 sites in 3 countries.

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

Anal fistula is defined as an abnormal communication between the anal canal and the perianal skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas. This study will test the safety and efficacy of ASCs (adipose stem cells) in the treatment of patients without Crohn´s disease. 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?
ASCs (Cx401, company code) and Fibrin adhesive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
10 sitesin 3 countries
Study dates
Feb 2007to Aug 2009
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

  • Patient with a complex perianal fistula. A complex perianal fistula must meet one of the following:
  • No fistula tract is palpated under the perianal skin or tract parallel to the rectum on examination with a stylet.
  • Associated anal incontinence in transsphincteric fistulas.
  • Risk factors for anal incontinence.
  • At least one prior surgery for a fistulous disease.
  • Suprasphincteric tracts shown by an image test.
Show all 10Show fewer
  • Women of childbearing age should have a negative serum or urine pregnancy test (sensitive to 25IU of hCG) and not be lactating before study entry. Both men and women should use adequate birth control methods as defined by the investigator.
  • Seton presence is allowed at the time of study entry and until cells (in groups receiving ASCs) or Fibrin adhesive are implanted.
  • No condition that may prevent the patient from following the study procedures until 26 weeks of follow-up are completed is foreseen.
  • Patient should give his/her signed, written informed consent. -

Who cannot join

  • Patient has been diagnosed with IBD
  • Patient has a rectovaginal fistula
  • Patient is pregnant or lactating woman
  • Patient has acute sepsis at the time of study entry
  • A liposuction to draw at least 100 cc of fat from the abdominal wall is not technically feasible.
  • Patient needs surgery in the perianal region for reasons other than fistulas
Show all 16Show fewer
  • Presence of two or more complex perianal fistulas
  • Patient has collections > 2 cm in MRI. If such collections exist, the surgeon may perform a complete toilette of the area.
  • Patient is allergic to local anesthetics or Gadolinium (MRI contrast agent).
  • MRI is not technically feasible.
  • Patient has abused alcohol or other addictive substances within 6 months of study entry.
  • Patient has active or latent infection by HIV, HBV or HCV.
  • Patient has undergone major surgery or sustained a severe trauma, in the investigator's judgment, within 28 days of recruitment.
  • Patient is receiving or has received immunomodulatory treatment for reasons other than the fistula within 6 months of study entry.
  • Patient has a malignant tumour, except for basal or squamous cell carcinoma of the skin, or has a prior history of a malignant tumour, except if the tumour has been in remission for at least the past 5 years.
  • -

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

Spain8 sites

  • Gregorio Marañon University Hospital

    Madrid, 28007

  • San Carlos Clinical Hospital

    Madrid, 28040

  • 12 De Octubre University Hospital

    Madrid, 28041

  • La Paz University Hospital

    Madrid, 28046

  • Virgen Del Camino Hospital

    Pamplona, Navarre, 31008

  • Mutua de Terrasa Hospital

    Tarrasa, Tarragona, 08221

  • Universitary General Hospital

    Valencia, 46014

  • Lozano Blesa Clinical Hospital

    Zaragoza, Aragon, 59009

Other trials in Spain

Germany1 site

  • Universitary Clinical Surgery

    Mannheim, D-68135

Other trials in Germany

United Kingdom1 site

  • John Radcliff Hospital

    Oxford, Oxfordshire

Other trials in United Kingdom

About this study

Official title: A Phase III Multicenter, Single Blind, Randomized, Comparative and add-on Clinical Trial, in Three Parallel Groups, to Evaluate Efficacy and Safety of a New Therapy With Adipose-derived Autologous Stem Cells for the Treatment of Complex Perianal Fistulas in Patients Without Inflammatory Bowel Disease

Anal fistula is defined as an abnormal communication between the anal canal and the perianal skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas. This study will test the safety and efficacy of ASCs (adipose stem cells) in the treatment of patients without Crohn´s disease.

Read the detailed description

Perianal fistula accounts for 10% to 30% of coloproctological surgical procedures. Currently accepted conventional treatment is surgery intended to treat the tracts using different technical options. This surgery usually has a highly bothersome postoperative period and may involve two major complications: anal incontinence and recurrence. The biological properties of stem cells derived from adult tissues make them adequate candidates for the treatment of diseases in which tissues are damaged or the healing process is altered. This study will compare the efficacy of ASCs versus ASCs plus Fibrin adhesive versus Fibrin adhesive alone for closure of complex perianal fistulas not associated to Inflammatory Bowel Disease. Fistula closure is defined as absence of suppuration and re-epithelization of the external opening in the clinical evaluation and absence of collections >2 cm directly related to the fistula tract treated, as measured by MRI

Conditions
Anal Fistula
Being tested
ASCs (Cx401, company code), Fibrin adhesive
Keywords
Autologous adipose-derived stem cells, Complex perianal fistula, Inflammatory Bowel Disease, Advanced cell therapy, Fibrin glue
Medical subject headings
Rectal Fistula, Inflammatory Bowel Diseases

What participants receive

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

  • ASCs (Cx401, company code)Drug

    Experimental: ASCs: Subjects will be treated with a dose of 20 million ASCs and evaluated after 12 weeks. If needed a second dose of 40 million ASCs will be applied then.

    Experimental: ASCs+fibrin glue: Subjects will be treated with a dose of 20 million ASCs plus fibrin glue and evaluated after 12 weeks. If needed a second dose of 40 million ASCs plus fibrin glue will be applied then.

  • Fibrin adhesiveDrug

    Experimental: Fibrin glue: Subjects will be treated with a dose fibrin glue and evaluated after 12 weeks. If needed a second dose of fibrin glue will be applied then.

Study groups in NCT00475410
Study groupRoleWhat they receive
ASCsExperimentalNot described
Receives: Drug: ASCs (Cx401, company code)
ASCs+fibrin glueExperimentalNot described
Receives: Drug: ASCs (Cx401, company code); Drug: Fibrin adhesive
Fibrin glueActive comparatorNot described
Receives: Drug: Fibrin adhesive

What is being measured

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

  1. 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)

    Measured: weeks 1, 4, 12 and 24. Week 26 in patients with a second dose

Secondary outcomes (1)

  1. • 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)

    Measured: weeks 1, 4, 12 and 24. Week 26 in patients with a second dose

Timeline

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

  1. First posted21 May 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionAug 2009
  4. Study completionAug 2009

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
214 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00475410
Sponsor's protocol ID
Cx401/FATT1
Other IDs
2006-003370-95
Acronym
FATT1
Status last verified
Apr 2019
First submitted
17 May 2007
Last updated
12 Apr 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.

    PubMed 12756590

  • Herreros MD, Garcia-Arranz M, Guadalajara H, De-La-Quintana P, Garcia-Olmo D; FATT Collaborative Group. Autologous expanded adipose-derived stem cells for the treatment of complex cryptoglandular perianal fistulas: a phase III randomized clinical trial (FATT 1: fistula Advanced Therapy Trial 1) and long-term evaluation. Dis Colon Rectum. 2012 Jul;55(7):762-72. doi: 10.1097/DCR.0b013e318255364a.

    PubMed 22706128

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ASCs (Cx401, company code) and Fibrin adhesive in people with Anal Fistula, run by Tigenix S.A.U. at 10 sites in 3 countries.

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 10 inclusion and 16 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 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain, Germany, United Kingdom. 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?

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 24. Week 26 in patients with a second dose). 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 NCT00475410, which also lists 3 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 12 Apr 2019.

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