Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)
Phase 1
Completed
- Conditions
- Rectovaginal FistulaCrohn Disease
- Interventions
- Drug: Expanded allogenic adipose-derived adult stem cells
- Registration Number
- NCT00999115
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Allogenic ASCs Expanded allogenic adipose-derived adult stem cells Intralesional dose of 20 million cells at baseline with a possible second administration of 40 million in case of incomplete fistula closure following week 12 assessment.
- Primary Outcome Measures
Name Time Method Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed 12 weeks
- Secondary Outcome Measures
Name Time Method Quality of life assessment using the SF-36 questionnaire 24 weeks Adverse events 1, 4, 8,12, 24, 54 weeks Clinically relevant variations in laboratory test 1, 4 8, 12, 24, 54 weeks
Trial Locations
- Locations (1)
Hospital Universitario La Paz
🇪🇸Madrid, Spain