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

Inclusion Criteria:

• Signed informed consent

• Patients with Crohn's disease diagnosed at least 12 months earlier in accordance withaccepted 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 luminalCrohn's disease defined by a CDAI ≤ 200. (Complex perianal fistula is defined as afistula that meets one or more of the following criteria: High fistulas [highinter-sphincteric, high trans-sphincteric, extra-sphincteric or supra-sphincteric],presence of 3 or fewer external openings [tracts] associated with a complex perianalfistula, or pain/fluctuation

• Good general state of health according to the findings of the clinical history and thephysical 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 bythe investigator

Exclusion Criteria:

• Presence of severe proctitis (prominent friability, spontaneous bleeding, multipleerosions, 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 thecollections and the absence of abscess and other collections is confirmed prior totreatment 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 weeksbefore the cell treatment administration

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

• Patients with rectovaginal fistula, anal fistula(s), and/or non-perianalenterocutaneous 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 6months prior to inclusion

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

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

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

• Patients with congenital or acquired immunodeficiencies

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

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

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

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

• Patients in need of surgery in the perianal region for reasons other than fistulas atthe time of inclusion in the study, or a need for such surgery is foreseen in thisregion 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 enrolmentinto this clinical trial, any investigational drug

• Patients unlikely to comply with study procedures