Recto-vaginal Fistula Clinical Trial
— HULPCIROfficial title:
A Phase II Clinical Trial to Study the Feasibility and Safety of Stromal Vascular Derived From Adipose Tissue for the Treatment of Recto-vaginal Fistula
The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | December 2013 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario La Paz | Madrid |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto de Investigación Hospital Universitario La Paz |
Spain,
Alvarez PD, García-Arranz M, Georgiev-Hristov T, García-Olmo D. A new bronchoscopic treatment of tracheomediastinal fistula using autologous adipose-derived stem cells. Thorax. 2008 Apr;63(4):374-6. doi: 10.1136/thx.2007.083857. — View Citation
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Tihomir Georgiev-Hristov, M.D.; Ignacio García-Gómez, Ph.D.; Prudencio Díaz-Agero, M.D.; Luz Vega-Clemente; Jacobo Trébol, M.D.; Damián García-Olmo, M.D., Ph.D.; Mariano García-Arranz, Ph.D. "SUTURES ENRICHED WITH ADIPOSE-DERIVED STEM CELLS FOR ENHANCED HEALING OF TRACHEAL ANASTOMOSIS IN RATS" Histology and Histopathology. 2010 (UNDER REVISION)
Trebol, J; Garcia-Arranz, M; Georgiev-Hristov, T, et al. Cell Therapy for Enterocutaneous Fistula Associated with Crohn's Disease: A Clinical and Biological Comparison of Protocols With and Without Cell Expansion. HUMAN GENE THERAPY 2009. 20 (9): 1045-1045
Vicente, A; Vazquez, MN; Entrena, A, Gqarcía-Arranz M,et al. BMP-4 Regulates the Expansion and Survival of Human Adipose Mesenchymal Cells. HUMAN GENE THERAPY .2009. 20 (9):1080-1081
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* Note: There are 19 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety of treatment of treated recto-vaginal fistulae. Percentage of treated enterocutaneous fistulae and percentage of subjects with closed fistulae | Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound | 16 weeks | Yes |
| Secondary | Quality of life assessment using the SF-12 Questionnaire | Test SF-12 of quality of life | 1, 4, 16, 24 weeks | No |
| Secondary | Adverse events | Control by investigation team of CRD (data collections) | 1, 4, 12, 24 weeks | Yes |