Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula (NCT01548092) | Clinical Trial Compass
UnknownPhase 1/2
Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula
Spain10 participantsStarted 2011-12
Plain-language summary
The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent
* Recto-vaginal fistula
* Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
* Crohn's disease diagnosed at least 3 months before accepting the clinical criteria
Exclusion Criteria:
* Presence of severe proctitis or dominant active luminal disease requiring immediately therapy
* 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 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, hepatitis B virus (HBV), hepatitis C virus (HCV) or treponema infection, whether active or latent
* Patients who have suffering major surgery or severe trauma in the prior 6 months
* Pregnant or breastf…
What they're measuring
1
Safety of treatment of treated recto-vaginal fistulae. Percentage of treated enterocutaneous fistulae and percentage of subjects with closed fistulae
Timeframe: 16 weeks
Trial details
NCT IDNCT01548092
SponsorInstituto de Investigación Hospital Universitario La Paz