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.

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to asses the safety and efficacy of adipose-derived adult stem cells from healthy donnors for treatment of complex perianal fistulas in Crohn's disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cellerix; Tigenix S.A.U.

Criteria

Inclusion Criteria:

• Signed informed consent.

• Subjects 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,

• Subjects with persistent and active complex perianal fistula and non active luminal CD defined by a CDAI ≤ 200.

• Subjects of either sex aged over 18 years. Good general state of health according to the findings of the clinical history and the physical examination.

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.