Enterocutaneous Fistula Clinical Trial
— HULPUTCOfficial title:
A Phase II Clinical Trial to Study the Feasibility and Safety of Stromal Vascular Derived From Adipose Tissue for the Treatment of Enterocutaneous Fistula
The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of enterocutaneous 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 - Enterocutaneous 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 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, HBV, 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. |
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,
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García Olmo D, Trébol J, Herreros D, Garcia-Arranz M, Gonzalez M. TREATMENT OF FISTULAS USING ADIPOSE-DERIVED STEM CELLS. En: García Olmo D, García-Verdugo JM, Alemany J, Gonzalez M, Gutierrez-Fuentes JA. CELL THERAPHY .2008 Ed. Mac Graw Hill. Madrid 2007
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Garcia-Gomez, I; Olmedillas, S; Garcia-Arranz, M, et al. Adipose-Derived Stem Cells Reduce Abdominal Adhesion Formation in a Rat Experimental Model. HUMAN GENE THERAPY 2009. 20 (9): 1047-1047
García-Olmo D, García-Arranz M, Herreros D, Pascual I, Peiro C, Rodríguez-Montes JA. A phase I clinical trial of the treatment of Crohn's fistula by adipose mesenchymal stem cell transplantation. Dis Colon Rectum. 2005 Jul;48(7):1416-23. — View Citation
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Garcia-Olmo D, Garcia-Arranz M, Herreros Marcos D, Pascual Miguelañez I. Fibrina y terapia celular en el tratamiento de la patología fistulosa en la enfermedad de Crohn. Protocolo y resultados de un ensayo clínico en fase I. Rev Esp Enferm Dig 2005. 97(Supl. II):51-54.)
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García-Olmo D, Herreros D, De-La-Quintana P, Guadalajara H, Trébol J, Georgiev-Hristov T, García-Arranz M. Adipose-derived stem cells in Crohn's rectovaginal fistula. Case Rep Med. 2010;2010:961758. doi: 10.1155/2010/961758. Epub 2010 Mar 7. — View Citation
Garcia-Olmo D, Herreros D, Guadalajara H, Trebol J, Georgiev T, García-Arranz M.Adipose Derived Stem Cell for Treatment of Crohn´s fistula. Histology and Histopathology. 2011; 26(ss1):356
Garcia-Olmo D, Herreros D, Pascual I, Pascual JA, Del-Valle E, Zorrilla J, De-La-Quintana P, Garcia-Arranz M, Pascual M. Expanded adipose-derived stem cells for the treatment of complex perianal fistula: a phase II clinical trial. Dis Colon Rectum. 2009 Jan;52(1):79-86. doi: 10.1007/DCR.0b013e3181973487. — View Citation
Garcia-Olmo D, Herreros D, Pascual M, Pascual I, De-La-Quintana P, Trebol J, Garcia-Arranz M. Treatment of enterocutaneous fistula in Crohn's Disease with adipose-derived stem cells: a comparison of protocols with and without cell expansion. Int J Colorectal Dis. 2009 Jan;24(1):27-30. doi: 10.1007/s00384-008-0559-0. Epub 2008 Aug 12. — View Citation
Garcia-Olmo, D; Guadalajara, H; Trebol, J, García-Arranz M. Expanded Adipose-Derived Stem Cells for the Treatment of Complex Perianal Fistula. HUMAN GENE THERAPY 2009. 20 (9):1028-1028
Georgiev-Hristov, T; Garcia-Olmo, D; Alvarez, PDA, et al. Use of Surgical Sutures Enriched with Adipose-Derived Stem Cells for Tracheal Anastomosis in Rats. HUMAN GENE THERAPY 2009. 20 (9): 1074-1075
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Pascual I, de Miguel GF, Gómez-Pinedo UA, de Miguel F, Arranz MG, García-Olmo D. Adipose-derived mesenchymal stem cells in biosutures do not improve healing of experimental colonic anastomoses. Br J Surg. 2008 Sep;95(9):1180-4. doi: 10.1002/bjs.6242. — View Citation
Pascual I, Fernández de Miguel G, García Arranz M, García-Olmo D. Biosutures improve healing of experimental weak colonic anastomoses. Int J Colorectal Dis. 2010 Dec;25(12):1447-51. doi: 10.1007/s00384-010-0952-3. Epub 2010 Jun 11. — View Citation
Trebol Lopez J, Georgiev Hristov T, García-Arranz M, García-Olmo D. Stem cell therapy for digestive tract diseases: current state and future perspectives. Stem Cells Dev. 2011 Jul;20(7):1113-29. doi: 10.1089/scd.2010.0277. Epub 2011 Feb 17. Review. — View Citation
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 López MA, Vázquez García MN, Entrena A, Olmedillas Lopez S, García-Arranz M, García-Olmo D, Zapata A. Low doses of bone morphogenetic protein 4 increase the survival of human adipose-derived stem cells maintaining their stemness and multipotency. Stem Cells Dev. 2011 Jun;20(6):1011-9. doi: 10.1089/scd.2010.0355. Epub 2010 Nov 4. — View Citation
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
Vilalta M, Dégano IR, Bagó J, Gould D, Santos M, García-Arranz M, Ayats R, Fuster C, Chernajovsky Y, García-Olmo D, Rubio N, Blanco J. Biodistribution, long-term survival, and safety of human adipose tissue-derived mesenchymal stem cells transplanted in nude mice by high sensitivity non-invasive bioluminescence imaging. Stem Cells Dev. 2008 Oct;17(5):993-1003. doi: 10.1089/scd.2007.0201. — View Citation
* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of treatment of treated enterocutaneous fistulae. Percentage of treated subjects with closed fistulae | Safety by analyzing the number of adverse effects associated with experimental treatment. | 16 weeks | Yes |
Secondary | quality of life test | Test SF 12 of quality of life | 16 week | No |
Secondary | First efficacy data | Fistula closure by radiology | 16 weeks | No |
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