Status:
COMPLETED
Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)
Lead Sponsor:
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Conditions:
Rectovaginal Fistula
Crohn Disease
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00999115
Start Date
September 1 2009
End Date
December 1 2011
Last Update
January 26 2012
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046