Stem Cells Treatment for Extremely Complex Fistulae (HULPCIR)
NCT ID: NCT01586715
Last Updated: 2012-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2012-03-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous Stem Cells
Adipose-derived stem cells without expanded
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
Interventions
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Adipose-derived stem cells without expanded
Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
Eligibility Criteria
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Inclusion Criteria
* Extremely Complex perianal fistulae
* Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination
* Previous failure in at least one closing fistula standard treatment
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Instituto de Investigación Hospital Universitario La Paz
OTHER
Responsible Party
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Principal Investigators
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Damián García Olmo, Prof MD
Role: PRINCIPAL_INVESTIGATOR
General Surgery Department (Hospital Universitario La Paz) and Cell Therapy laboratory
Locations
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Hospital Universitario La Paz
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Bey NM. A new technique in dealing with superior rectovaginal fistulae. J. Obstrt Gynecol 1934. 41: 579-587
Given FT Jr. Rectovaginal fistula. A review of 20 years' experience in a community hospital. Am J Obstet Gynecol. 1970 Sep 1;108(1):41-6. No abstract available.
Daniels BT. Rectovaginal fistula: a clinical and pathological study. Doctoral dissertation. Minneapolis: University of Minnesota 1949
LAIRD DR. Procedures used in treatment of complicated fistulas. Am J Surg. 1948 Dec;76(6):701-8. doi: 10.1016/s0002-9610(48)90211-6. No abstract available.
Hoexter B, Labow SB, Moseson MD. Transanal rectovaginal fistula repair. Dis Colon Rectum. 1985 Aug;28(8):572-5. doi: 10.1007/BF02554145.
Fry RD, Shemesh EI, Kodner IJ, Timmcke A. Techniques and results in the management of anal and perianal Crohn's disease. Surg Gynecol Obstet. 1989 Jan;168(1):42-8.
Radcliffe AG, Ritchie JK, Hawley PR, Lennard-Jones JE, Northover JM. Anovaginal and rectovaginal fistulas in Crohn's disease. Dis Colon Rectum. 1988 Feb;31(2):94-9. doi: 10.1007/BF02562636.
Tuxen PA, Castro AF. Rectovaginal fistula in Crohn's disease. Dis Colon Rectum. 1979 Jan-Feb;22(1):58-62. doi: 10.1007/BF02586761. No abstract available.
Hellers G, Bergstrand O, Ewerth S, Holmstrom B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7. doi: 10.1136/gut.21.6.525.
Bandy LC, Addison A, Parker RT. Surgical management of rectovaginal fistulas in Crohn's disease. Am J Obstet Gynecol. 1983 Oct 15;147(4):359-63. doi: 10.1016/s0002-9378(16)32225-6.
Bauer JJ, Sher ME, Jaffin H, Present D, Gelerent I. Transvaginal approach for repair of rectovaginal fistulae complicating Crohn's disease. Ann Surg. 1991 Feb;213(2):151-8. doi: 10.1097/00000658-199102000-00010.
Tsang CB, Madoff RD, Wong WD, Rothenberger DA, Finne CO, Singer D, Lowry AC. Anal sphincter integrity and function influences outcome in rectovaginal fistula repair. Dis Colon Rectum. 1998 Sep;41(9):1141-6. doi: 10.1007/BF02239436.
Andreani SM, Dang HH, Grondona P, Khan AZ, Edwards DP. Rectovaginal fistula in Crohn's disease. Dis Colon Rectum. 2007 Dec;50(12):2215-22. doi: 10.1007/s10350-007-9057-7. Epub 2007 Sep 11.
García Olmo D, García-Verdugo JM, Alemany J, Gonzalez M, Gutierrez-Fuentes JA. CELL THERAPHY . Ed. Mac Graw Hill. Madrid 2007
Aggarwal S, Pittenger MF. Human mesenchymal stem cells modulate allogeneic immune cell responses. Blood. 2005 Feb 15;105(4):1815-22. doi: 10.1182/blood-2004-04-1559. Epub 2004 Oct 19.
Puissant B, Barreau C, Bourin P, Clavel C, Corre J, Bousquet C, Taureau C, Cousin B, Abbal M, Laharrague P, Penicaud L, Casteilla L, Blancher A. Immunomodulatory effect of human adipose tissue-derived adult stem cells: comparison with bone marrow mesenchymal stem cells. Br J Haematol. 2005 Apr;129(1):118-29. doi: 10.1111/j.1365-2141.2005.05409.x.
Tse WT, Pendleton JD, Beyer WM, Egalka MC, Guinan EC. Suppression of allogeneic T-cell proliferation by human marrow stromal cells: implications in transplantation. Transplantation. 2003 Feb 15;75(3):389-97. doi: 10.1097/01.TP.0000045055.63901.A9.
Chamberlain G, Fox J, Ashton B, Middleton J. Concise review: mesenchymal stem cells: their phenotype, differentiation capacity, immunological features, and potential for homing. Stem Cells. 2007 Nov;25(11):2739-49. doi: 10.1634/stemcells.2007-0197. Epub 2007 Jul 26.
Le Blanc K, Ringden O. Immunobiology of human mesenchymal stem cells and future use in hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2005 May;11(5):321-34. doi: 10.1016/j.bbmt.2005.01.005.
Maccario R, Podesta M, Moretta A, Cometa A, Comoli P, Montagna D, Daudt L, Ibatici A, Piaggio G, Pozzi S, Frassoni F, Locatelli F. Interaction of human mesenchymal stem cells with cells involved in alloantigen-specific immune response favors the differentiation of CD4+ T-cell subsets expressing a regulatory/suppressive phenotype. Haematologica. 2005 Apr;90(4):516-25.
Barrett AJ, Rezvani K, Solomon S, Dickinson AM, Wang XN, Stark G, Cullup H, Jarvis M, Middleton PG, Chao N. New developments in allotransplant immunology. Hematology Am Soc Hematol Educ Program. 2003:350-71. doi: 10.1182/asheducation-2003.1.350.
Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20.
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.
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.
Other Identifiers
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2010-024329-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HULPCIR-2010-01
Identifier Type: -
Identifier Source: org_study_id
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