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

NCT00475410 | Completed Phase 3

• 2 other identifiers: Cx401/FATT12006-003370-95
• Study Type: interventional
• Target: 214
• Locations: 3 countries
• Sites: 10

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.

Conditions

Anal Fistula

Keywords

Autologous adipose-derived stem cells; Complex perianal fistula; Inflammatory Bowel Disease; Advanced cell therapy; Fibrin glue

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (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)

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

Study Arms (3)

ASCs

EXPERIMENTAL

Drug: ASCs (Cx401, company code)

ASCs+fibrin glue

EXPERIMENTAL

Drug: ASCs (Cx401, company code); Drug: Fibrin adhesive

Fibrin glue

ACTIVE COMPARATOR

Drug: Fibrin adhesive

Interventions

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.

ASCs; ASCs+fibrin glue

Fibrin adhesive DRUG

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.

ASCs+fibrin glue; Fibrin glue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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. -

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Tigenix S.A.U.: lead

Study Sites (10)

Universitary Clinical Surgery

Mannheim, D-68135, Germany

Location

Lozano Blesa Clinical Hospital

Zaragoza, Aragon, 59009, Spain

Location

Virgen Del Camino Hospital

Pamplona, Navarre, 31008, Spain

Location

Mutua de Terrasa Hospital

Tarrasa, Tarragona, 08221, Spain

Location

Gregorio Marañon University Hospital

Madrid, 28007, Spain

Location

San Carlos Clinical Hospital

Madrid, 28040, Spain

Location

12 De Octubre University Hospital

Madrid, 28041, Spain

Location

La Paz University Hospital

Madrid, 28046, Spain

Location

Universitary General Hospital

Valencia, 46014, Spain

Location

John Radcliff Hospital

Oxford, Oxfordshire, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 15933795 RESULT

• 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.

  PMID: 12756590 RESULT

• 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.

  PMID: 22706128 DERIVED

MeSH Terms

Conditions

Rectal Fistula; Inflammatory Bowel Diseases

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Gastroenteritis

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Damian Garcia Olmo, Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: February 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

ES (8); GB (1); DE (1)