Stromal Vascular Fraction (SVF) for Treatment of Enterocutaneous Fistula (HULPUTC) (HULPUTC)
Primary Purpose
Enterocutaneous Fistula
Status
Unknown status
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Adipose-derived stem cells without expanded
Sponsored by
About this trial
This is an interventional treatment trial for Enterocutaneous Fistula focused on measuring Enterocutaneous fistula, Adipose Derived Stem Cells
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario La PazRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adipose derived Stem Cells
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
quality of life test
Test SF 12 of quality of life
First efficacy data
Fistula closure by radiology
Full Information
NCT ID
NCT01584713
First Posted
February 26, 2012
Last Updated
April 23, 2012
Sponsor
Instituto de Investigación Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT01584713
Brief Title
Stromal Vascular Fraction (SVF) for Treatment of Enterocutaneous Fistula (HULPUTC)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of enterocutaneous fistula.
Detailed Description
SF-12 Test
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterocutaneous Fistula
Keywords
Enterocutaneous fistula, Adipose Derived Stem Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adipose derived Stem Cells
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Adipose-derived stem cells without expanded
Other Intervention Name(s)
Non applicable
Intervention Description
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
Primary Outcome Measure Information:
Title
Safety of treatment of treated enterocutaneous fistulae. Percentage of treated subjects with closed fistulae
Description
Safety by analyzing the number of adverse effects associated with experimental treatment.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
quality of life test
Description
Test SF 12 of quality of life
Time Frame
16 week
Title
First efficacy data
Description
Fistula closure by radiology
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariano Garcia Arranz
Phone
+34912071022
Email
mgarciaa.hulp@salud.madrid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Héctor Guadalajara Labajo
Phone
+34912071022
Email
h.guadalajara@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariano Garcia-Arranz, Doctor
Organizational Affiliation
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariano García Arranz
Phone
+34912071022
Email
mgarciaa.hulp@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Héctor Guadalajara Labajo
First Name & Middle Initial & Last Name & Degree
Damián García Olmo
First Name & Middle Initial & Last Name & Degree
Tihomir G Hirstov
12. IPD Sharing Statement
Citations:
PubMed Identifier
15933795
Citation
Garcia-Olmo D, Garcia-Arranz M, Herreros D, Pascual I, Peiro C, Rodriguez-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. doi: 10.1007/s10350-005-0052-6.
Results Reference
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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.)
Results Reference
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Citation
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.
Results Reference
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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
Results Reference
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PubMed Identifier
18364447
Citation
Alvarez PD, Garcia-Arranz M, Georgiev-Hristov T, Garcia-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.
Results Reference
background
PubMed Identifier
18694359
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.
Results Reference
background
PubMed Identifier
18690635
Citation
Pascual I, de Miguel GF, Gomez-Pinedo UA, de Miguel F, Arranz MG, Garcia-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.
Results Reference
background
PubMed Identifier
18537463
Citation
Vilalta M, Degano IR, Bago J, Gould D, Santos M, Garcia-Arranz M, Ayats R, Fuster C, Chernajovsky Y, Garcia-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.
Results Reference
background
PubMed Identifier
19273960
Citation
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.
Results Reference
background
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
Results Reference
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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
Results Reference
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Citation
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
Results Reference
background
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
Results Reference
background
PubMed Identifier
18696086
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.
Results Reference
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PubMed Identifier
20224798
Citation
Garcia-Olmo D, Herreros D, De-La-Quintana P, Guadalajara H, Trebol J, Georgiev-Hristov T, Garcia-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.
Results Reference
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PubMed Identifier
20544210
Citation
Pascual I, Fernandez de Miguel G, Garcia Arranz M, Garcia-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.
Results Reference
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PubMed Identifier
20636801
Citation
Garcia-Arranz M, Gomez-Pinedo U, Hardisson D, Herreros D, Guadalajara H, Garcia-Gomez I, Garcia-Verdugo JM, Garcia-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. No abstract available.
Results Reference
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PubMed Identifier
20831449
Citation
Garcia-Gomez I, Elvira G, Zapata AG, Lamana ML, Ramirez M, Castro JG, Arranz MG, Vicente A, Bueren J, Garcia-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.
Results Reference
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PubMed Identifier
20846028
Citation
Vicente Lopez MA, Vazquez Garcia MN, Entrena A, Olmedillas Lopez S, Garcia-Arranz M, Garcia-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.
Results Reference
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PubMed Identifier
21187000
Citation
Trebol Lopez J, Georgiev Hristov T, Garcia-Arranz M, Garcia-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.
Results Reference
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PubMed Identifier
21459345
Citation
Garcia-Olmo D, Garcia-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. No abstract available. Spanish.
Results Reference
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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
Results Reference
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Stromal Vascular Fraction (SVF) for Treatment of Enterocutaneous Fistula (HULPUTC)
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