Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-04-02 @ 12:45 AM
Study NCT ID:
NCT00115466
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}, {'id': 'D005402', 'term': 'Fistula'}], 'ancestors': [{'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': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-06', 'completionDateStruct': {'date': '2006-07'}, 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2005-06-22', 'studyFirstSubmitQcDate': '2005-06-22', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization)'}], 'secondaryOutcomes': [{'measure': 'No fistula recurrence after 1 year follow-up'}]}, 'conditionsModule': {'keywords': ['ASCs (adult stem cells derived from adipose tissue)', 'Fistula', 'Cell Therapy', 'Complex perianal fistula'], 'conditions': ['Anal Fistula']}, 'referencesModule': {'references': [{'pmid': '12756590', 'type': 'RESULT', '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."}]}, 'descriptionModule': {'briefSummary': 'This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the non-surgical treatment of complex perianal fistula.', 'detailedDescription': 'Comparative, multicentre, randomised clinical trial, designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the NON-SURGICAL treatment of complex perianal fistula. The closure/healing of the fistula will be evaluated periodically, and it will be considered completely closed if there is no suppuration from the external orifice and re-epithelialisation can be observed at 8 weeks after the administration of the randomised therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients of both sexes older than 18 years of age.\n* Patients with a complex perianal fistula pathology which we define as the subjects that fulfil some of the following conditions:\n\n * No palpation of the fistula tract beneath the perianal skin.\n * A tract that is parallel to the rectum on exploration with a stylet.\n * Associated faecal incontinence.\n * Risk factors of anal incontinence.\n * At least one previous operation for a fistulous disorder.\n * Suprasphincteric trajectories\n * Rectovaginal fistula\n * Prior diagnosis of Crohn's disease.\n* Patients from whom written informed consent has been obtained for them to participate in the study prior to performing any procedure described in the study.\n* Patients that have already been subjected to a colonoscopy within a period of up to 6 months prior to the study.\n\nExclusion Criteria:\n\n* Patients that are extremely thin who should not be subjected to liposuction.\n* Known allergy to local anaesthetics or to bovine proteins\n* History of neoplasia in the past 5 years.\n* Patients with a diagnosis of active Tuberculosis at the moment of inclusion.\n* Patients with prior positive markers for any of the following pathogens: Hepatitis B and C, HIV-1 or HIV-2.\n* Any other medical condition that in the judgement of the investigator could interfere with their optimal participation in the study or produce a significant risk to the patient.\n* Patients that have participated in another study in the 30 days prior to this one or that have planned to participate simultaneously in another study.\n* Patients that have not given their informed consent to participate in this study.\n* Psychiatric disorder or other factors that in the judgement of the investigator could complicate the participation of the patient in the study.\n* Breast feeding, gestation or intention to become pregnant up to 6 months after finalising their participation in the study, or that are not using adequate methods of contraception during the same period."}, 'identificationModule': {'nctId': 'NCT00115466', 'briefTitle': 'Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cellerix'}, 'officialTitle': 'Phase II Clinical Trial, Multicentre, Randomised and Comparative, to Evaluate the Efficacy and Safety of a New Therapy With Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula', 'orgStudyIdInfo': {'id': 'GX401/TCFIS'}, 'secondaryIdInfos': [{'id': 'Nr. 04-0211'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Non-surgical autologous implant of ASCs', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28760', 'city': 'Tres Cantos', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Cellerix Sl', 'geoPoint': {'lat': 40.60092, 'lon': -3.70806}}], 'overallOfficials': [{'name': 'Damian Garcia-Olmo, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cellerix'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cellerix', 'class': 'INDUSTRY'}}}}