Stromal Vascular Fraction (SVF) for Treatment of Enterocutaneous Fistula (HULPUTC)

Enterocutaneous Fistula Clinical Trial

— HULPUTC  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01584713
• Other study ID #: EC10-345
• Secondary ID: 2010-024308-82
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 26, 2012
• Last updated: April 23, 2012
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2012
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Mariano Garcia Arranz
• Phone: +34912071022
• Email: mgarciaa.hulp[@]salud.madrid.org
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Description:

SF-12 Test

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enterocutaneous Fistula
• Fistula
• Intestinal Fistula

Intervention

Drug:
• Adipose-derived stem cells without expanded
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (23)

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

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

García-Arranz M, Gómez-Pinedo U, Hardisson D, Herreros D, Guadalajara H, García-Gómez I, García-Verdugo JM, García-Olmo D. Histopathological analysis of human specimens removed from the injection area of expanded adipose-derived stem cells. Histopathology. 2010 Jun;56(7):979-82. doi: 10.1111/j.1365-2559.2010.03573.x. — View Citation

García-Gómez I, Elvira G, Zapata AG, Lamana ML, Ramírez M, Castro JG, Arranz MG, Vicente A, Bueren J, García-Olmo D. Mesenchymal stem cells: biological properties and clinical applications. Expert Opin Biol Ther. 2010 Oct;10(10):1453-68. doi: 10.1517/14712598.2010.519333. Review. — View Citation

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

Garcia-Olmo D, Garcia-Arranz M, Herreros D. Expanded adipose-derived stem cells for the treatment of complex perianal fistula including Crohn's disease. Expert Opin Biol Ther. 2008 Sep;8(9):1417-23. doi: 10.1517/14712598.8.9.1417 . Review. — View Citation

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.)

García-Olmo D, García-Arranz M. [Cells for curing. From the heart to everything]. An Pediatr (Barc). 2011 Apr;74(4):215-7. doi: 10.1016/j.anpedi.2011.02.021. Spanish. — View Citation

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

Herreros Marcos D, Garcia-Arranz M, Pascual Miguelañez I, Garcia-Olmo D. THE ROLE OF STEM CELLS IN SUPPURATIVE ENVIROMENTS. Experimental Dermatology 2006, 15 (6): 482.

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

Outcome

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