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Efficacy and Safety of Adipose Stem Cells to Treat Complex Perianal Fistulas Not Associated to Crohn´s Disease (FATT1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00475410
Recruitment Status : Completed
First Posted : May 21, 2007
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda ( Tigenix S.A.U. )

Brief 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.

Condition or disease Intervention/treatment Phase
Anal Fistula Drug: ASCs (Cx401, company code) Drug: Fibrin adhesive Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: ASCs Drug: ASCs (Cx401, company code)

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.


Experimental: ASCs+fibrin glue Drug: ASCs (Cx401, company code)

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.


Drug: Fibrin adhesive
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.

Active Comparator: Fibrin glue Drug: Fibrin adhesive
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.




Primary Outcome Measures :
  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) [ Time Frame: weeks 1, 4, 12 and 24. Week 26 in patients with a second dose ]

Secondary Outcome Measures :
  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) [ Time Frame: weeks 1, 4, 12 and 24. Week 26 in patients with a second dose ]


Information from the National Library of Medicine

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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. 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.
  2. 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.
  3. Seton presence is allowed at the time of study entry and until cells (in groups receiving ASCs) or Fibrin adhesive are implanted.
  4. No condition that may prevent the patient from following the study procedures until 26 weeks of follow-up are completed is foreseen.
  5. Patient should give his/her signed, written informed consent. -

Exclusion Criteria:

  1. Patient has been diagnosed with IBD
  2. Patient has a rectovaginal fistula
  3. Patient is pregnant or lactating woman
  4. Patient has acute sepsis at the time of study entry
  5. A liposuction to draw at least 100 cc of fat from the abdominal wall is not technically feasible.
  6. Patient needs surgery in the perianal region for reasons other than fistulas
  7. Presence of two or more complex perianal fistulas
  8. Patient has collections > 2 cm in MRI. If such collections exist, the surgeon may perform a complete toilette of the area.
  9. Patient is allergic to local anesthetics or Gadolinium (MRI contrast agent).
  10. MRI is not technically feasible.
  11. Patient has abused alcohol or other addictive substances within 6 months of study entry.
  12. Patient has active or latent infection by HIV, HBV or HCV.
  13. Patient has undergone major surgery or sustained a severe trauma, in the investigator's judgment, within 28 days of recruitment.
  14. Patient is receiving or has received immunomodulatory treatment for reasons other than the fistula within 6 months of study entry.
  15. 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.

    -


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): NCT00475410


Locations
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Germany
Universitary Clinical Surgery
Mannheim, Germany, D-68135
Spain
Lozano Blesa Clinical Hospital
Zaragoza, Aragon, Spain, 59009
Virgen Del Camino Hospital
Pamplona, Navarra, Spain, 31008
Mutua de Terrasa Hospital
Tarrasa, Tarragona, Spain, 08221
Gregorio Marañon University Hospital
Madrid, Spain, 28007
San Carlos Clinical Hospital
Madrid, Spain, 28040
12 De Octubre University Hospital
Madrid, Spain, 28041
La Paz University Hospital
Madrid, Spain, 28046
Universitary General Hospital
Valencia, Spain, 46014
United Kingdom
John Radcliff Hospital
Oxford, Oxfordshire, United Kingdom
Sponsors and Collaborators
Tigenix S.A.U.
Investigators
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Principal Investigator: Damian Garcia Olmo, Dr
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tigenix S.A.U.
ClinicalTrials.gov Identifier: NCT00475410    
Other Study ID Numbers: Cx401/FATT1
2006-003370-95 ( Other Identifier: EMEA )
First Posted: May 21, 2007    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Keywords provided by Takeda ( Tigenix S.A.U. ):
Autologous adipose-derived stem cells
Complex perianal fistula
Inflammatory Bowel Disease
Advanced cell therapy
Fibrin glue
Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Rectal Fistula
Fistula
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants