Recto-vaginal Fistula
Conditions
Keywords
Recto-vaginal fistula, Adipose Derived Stem Cells
Brief summary
The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.
Detailed description
SF-12 Test
Interventions
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
Sponsors
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of treatment of treated recto-vaginal fistulae. Percentage of treated enterocutaneous fistulae and percentage of subjects with closed fistulae | 16 weeks | Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessment using the SF-12 Questionnaire | 1, 4, 16, 24 weeks | Test SF-12 of quality of life |
| Adverse events | 1, 4, 12, 24 weeks | Control by investigation team of CRD (data collections) |
Countries
Spain
Contacts
Primary ContactMariano Garcia Arranz
Backup ContactMaria Dolores Herreos
Outcome results
None listed