Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Assoc… (NCT00999115) | Clinical Trial Compass
CompletedPhase 1/2
Allogenic Stem Cells Derived From Lipoaspirates for the Treatment of Recto-vaginal Fistulas Associated to Crohn's Disease (ALOREVA)
Spain10 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 i…
What they're measuring
1
Percentage of subjects in whom the external openings of the treated rectovaginal fistula have closed
Timeframe: 12 weeks
Trial details
NCT IDNCT00999115
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario la Paz