Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease

• Status: Terminated
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine safety and efficacy of eASCs (expanded adult stem cells) for treatment of complex perianal fistulas in patients with Crohn's disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cellerix; Tigenix S.A.U.
• Treatments: Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• Signed informed consent

• Patients with Crohn's disease diagnosed at least 12 months earlier in accordance with accepted clinical, endoscopic, anatomopathological and/or radiologic criteria

• Presence of complex perianal fistula with 3 or fewer fistulous tracts assessed by MRI

• Patients with persistent and active complex perianal fistula and non-active luminal Crohn's disease defined by a CDAI ≤ 200. (Complex perianal fistula is defined as a fistula that meets one or more of the following criteria: High fistulas [high inter-sphincteric, high trans-sphincteric, extra-sphincteric or supra-sphincteric], presence of 3 or fewer external openings [tracts] associated with a complex perianal fistula, or pain/fluctuation

• Good general state of health according to the findings of the clinical history and the physical examination

• Women of a childbearing age with negative serum or urine pregnancy test (sensitive to 25 IU hCG). Both men and women should use appropriate birth control methods defined by the investigator

Exclusion Criteria:

• Presence of severe proctitis (prominent friability, spontaneous bleeding, multiple erosions, deep ulcers) or dominant active luminal disease requiring immediate therapy, assessed by rectosigmoidoscopy

• Patients with a CDAI ≥201

• Patients with an abscess unless a complete toilet of the area with drainage of the collections and the absence of abscess and other collections is confirmed prior to treatment start

• The presence of setons unless removed prior to the study procedure

• Presence of >3 fistulous tracts and/or external openings

• Patients with rectal and/or anal stenosis evaluated by rectoscopy or EUA

• Patients who have received infliximab or any other anti-TNF agent in the 8 weeks before the cell treatment administration

• Patients who have received tacrolimus or cyclosporine in the 4 weeks before the cell treatment administration

• Patients with rectovaginal fistula, anal fistula(s), and/or non-perianal enterocutaneous fistula

• Patients with HIV, HBV, HCV or treponema infection, whether active or latent

• Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion

• Patients with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or patients with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years

• Patients with cardiopulmonary disease which, in the opinion of the investigator, is unstable or sufficiently serious to exclude the patient from the study.

• Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from the study

• Patients with congenital or acquired immunodeficiencies

• Patients with abnormal laboratory test findings that contraindicate their inclusion in the study

• Patients allergic to local anesthetics or gadolinium (MRI contrast)

• MRI is unfeasible, (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia)

• Liposuction with extraction of at least 100 cm3 of fat from the abdominal wall is technically unfeasible or the patient does not consent to the procedure

• Patients in need of surgery in the perianal region for reasons other than fistulas at the time of inclusion in the study, or a need for such surgery is foreseen in this region in the 26 weeks after treatment administration.

• Patients who have suffered major surgery or severe trauma in the prior 6 months

• Pregnant or breastfeeding women

• Patients who do not wish to or cannot comply with study procedures

• Patients currently receiving, or having received within 1 month prior to enrolment into this clinical trial, any investigational drug

• Patients unlikely to comply with study procedures