Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-27 @ 2:28 PM
Study NCT ID:
NCT01548092
Status:
UNKNOWN
Last Update Posted:
2012-03-08
First Post:
2012-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012006', 'term': 'Rectovaginal Fistula'}], 'ancestors': [{'id': 'D012003', 'term': 'Rectal Fistula'}, {'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014624', 'term': 'Vaginal Fistula'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-05', 'studyFirstSubmitDate': '2012-02-26', 'studyFirstSubmitQcDate': '2012-03-05', 'lastUpdatePostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of treatment of treated recto-vaginal fistulae. Percentage of treated enterocutaneous fistulae and percentage of subjects with closed fistulae', 'timeFrame': '16 weeks', 'description': 'Safety by control the adverse effects associated with treatment Fistula close by 3D ultrasound'}], 'secondaryOutcomes': [{'measure': 'Quality of life assessment using the SF-12 Questionnaire', 'timeFrame': '1, 4, 16, 24 weeks', 'description': 'Test SF-12 of quality of life'}, {'measure': 'Adverse events', 'timeFrame': '1, 4, 12, 24 weeks', 'description': 'Control by investigation team of CRD (data collections)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Recto-vaginal fistula', 'Adipose Derived Stem Cells'], 'conditions': ['Recto-vaginal Fistula']}, 'referencesModule': {'references': [{'pmid': '12756590', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '15933795', 'type': 'BACKGROUND', '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."}, {'type': 'BACKGROUND', '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'}, {'pmid': '18696086', 'type': 'BACKGROUND', '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."}, {'pmid': '18364447', 'type': 'BACKGROUND', '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.'}, {'pmid': '18537463', 'type': 'BACKGROUND', '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.'}, {'pmid': '19273960', 'type': 'BACKGROUND', '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.'}, {'pmid': '18690635', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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 . Ed. Mac Graw Hill. Madrid 2007)'}, {'pmid': '18694359', 'type': 'BACKGROUND', '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."}, {'type': 'BACKGROUND', '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'}, {'type': '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"}, {'type': 'BACKGROUND', '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'}, {'type': 'BACKGROUND', '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'}, {'type': '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'}, {'pmid': '20068178', 'type': 'BACKGROUND', 'citation': 'Garcia-Olmo DC, Dominguez C, Garcia-Arranz M, Anker P, Stroun M, Garcia-Verdugo JM, Garcia-Olmo D. Cell-free nucleic acids circulating in the plasma of colorectal cancer patients induce the oncogenic transformation of susceptible cultured cells. Cancer Res. 2010 Jan 15;70(2):560-7. doi: 10.1158/0008-5472.CAN-09-3513. Epub 2010 Jan 12.'}, {'pmid': '20636801', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': '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)'}, {'pmid': '20224798', 'type': 'BACKGROUND', '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."}, {'type': 'BACKGROUND', 'citation': 'Pascual I, De Miguel Fernandez G, García-Arranz M, García-Olmo D.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine safety of Stromal Vascular Fraction (SVF) for the treatment of recto-vaginal fistula.', 'detailedDescription': 'SF-12 Test'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed informed consent\n* Recto-vaginal fistula\n* Men and women over 18 years old. Good general state of health according to the findings of the clinical history and the physical examination\n* Crohn's disease diagnosed at least 3 months before accepting the clinical criteria\n\nExclusion Criteria:\n\n* Presence of severe proctitis or dominant active luminal disease requiring immediately therapy\n* 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\n* Patients with a history of abuse of alcohol or other addictive substances in the 6 months prior to inclusion\n* 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\n* Patients with cardiopulmonary disease which, in opinion of the investigator, in unstable or sufficiently serious to exclude the patient from the study.\n* Patients with any type of medical or psychiatric disease which, in the opinion of the investigator, could be grounds for exclusion from study\n* Patients with congenital or acquired immunodeficiencies. HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) or treponema infection, whether active or latent\n* Patients who have suffering major surgery or severe trauma in the prior 6 months\n* Pregnant or breastfeeding women\n* Patients currently receiving, or having received within 1 month prior to enrollment into this clinical trial, any investigational drug.\n* Crohns Disease Activity Index (CDAI) Index above 200"}, 'identificationModule': {'nctId': 'NCT01548092', 'acronym': 'HULPCIR', 'briefTitle': 'Stromal Vascular Fraction (SVF) for Treatment of Recto-vaginal Fistula', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Investigación Hospital Universitario La Paz'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EC10-343'}, 'secondaryIdInfos': [{'id': '2010-024330-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous SVF', 'description': 'Intralesional application', 'interventionNames': ['Drug: Adipose-derived stem cells without expanded']}], 'interventions': [{'name': 'Adipose-derived stem cells without expanded', 'type': 'DRUG', 'otherNames': ['Adipose-Derived Mesenchymal Stem Cells'], 'description': 'Administration will be intralesional injection of cells suspension. They will be placed into fistula walls', 'armGroupLabels': ['Autologous SVF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28039', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Mariano García Arranz', 'role': 'CONTACT', 'email': 'mgarciaa.hulp@salud.madrid.org', 'phone': '+34912071022'}, {'name': 'Maria Dolores Herreros', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Damián García Olmo', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tihomir Hirstov', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Héctor Guadalajara', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Mariano Garcia Arranz', 'role': 'CONTACT', 'email': 'mgarciaa.hulp@salud.madrid.org', 'phone': '+34912071022'}, {'name': 'Maria Dolores Herreos', 'role': 'CONTACT', 'email': 'loles.herreros@gmail.com', 'phone': '+34912071022'}], 'overallOfficials': [{'name': 'Mariano García Arranz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cell Therapy laboratory and general Surgery Department, Hospital Universitario La Paz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Investigación Hospital Universitario La Paz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}