Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula (HULPCIR)

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Recto-vaginal Fistula

Treatments: Drug: Adipose-derived stem cells without expanded

Study type: Interventional

Funder types: Other

Identifiers

NCT01548092

EC10-343

2010-024330-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.

Full description

SF-12 Test

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 breastfeeding women
• Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.
• Crohns Disease Activity Index (CDAI) Index above 200

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Autologous SVF

Experimental group

Description:

Intralesional application

Treatment:

Drug: Adipose-derived stem cells without expanded