Study to Assess the Safety and Efficacy of Expanded Allogenic Adipose-derived Stem Cells (eASCs) (Cx601), for Treatment of Complex Perianal Fistulas in Perianal Crohn's Disease.

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
• •Subjects with a CDAI ≥ 221.
• •Subjects 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 treatment start.
• •Presence of \>3 fistulous tracts and/or external openings.
• •Subjects with rectal and/or anal stenosis evaluated by rectoscopy or EUA.
• •Subjects who have received infliximab or any other anti-TNF agent in the 8 weeks before the cell treatment administration.
• •Subjects who have received tracrolimus or ciclosporine in the 4 weeks before the cell treatment administration.
• •Subjects with rectovaginal fistula, anal fistula(s), and/or non-perianal enterocutaneous fistula.
• •Subjects with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion.
• •Subjects with malignant tumor, except for basal cell or cutaneous squamous cell carcinoma, or Subjects with a prior history of malignant tumors, unless the neoplastic disease has been in remission for the previous 5 years.
• •Subjects with cardiopulmonary disease which, in the opinion of the investigator, is unstable or sufficiently serious to exclude the patient from the study.
• •Subjects with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from the study.
• •Subjects with congenital or acquired immunodeficiencies.
• •Subjects with abnormal laboratory test findings that contraindicate their inclusion in the study.
• •Subjects allergic to anesthetics or MRI contrast.
• •MRI is unfeasible, (e.g. due to the presence of pacemakers, hip replacements or severe claustrophobia)
• •Subjects 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.
• •Subjects who have suffered major surgery or severe trauma in the prior 6 months.
• •Pregnant or breastfeeding women. (Both men and women should use appropriate birth control methods defined by the investigator).
• •Subjects currently receiving, or having received within 1 month prior to enrolment into this clinical trial, any investigational drug.