Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.

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

Details

• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz

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.

• Fulfilling one of the following criteria:

• At least, one previous surgery for fistulous disease.

• Physical status which discourage liposuction.

• Rectovaginal fistula.

• Women of a childbearing age. 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

• Patients with 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

• 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 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 opinion of the investigator, in 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 study

• Patients with congenital or acquired immunodeficiencies. HIV, HBV, HCV or treponema infection, whether active or latent.

• 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)

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

• Pregnant or breastfeeding women

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