Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-31 @ 4:16 AM
Study NCT ID:
NCT05322057
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2022-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-03', 'studyFirstSubmitDate': '2022-04-03', 'studyFirstSubmitQcDate': '2022-04-03', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fistula Closure', 'timeFrame': '1 year', 'description': "The study's primary endpoint was established at week 52 with clinically assessed fistula closure."}], 'secondaryOutcomes': [{'measure': 'Evaluation of perianal disease', 'timeFrame': '1 year', 'description': 'At every follow up visit the perianal disease was evaluated using the PDAI (Perianal disease activity index)'}, {'measure': "Evaluation of Crohn's disease", 'timeFrame': '1 year', 'description': "Crohn's disease was evaluated by using the HBI (Harvey Bradshaw Index)"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease', 'Fistula Perianal']}, 'descriptionModule': {'briefSummary': "The use of mesenchymal stem cells is considered a novel and promising therapeutic option for patients with perianal fistulizing Crohn's disease. However, due to limited clinical data, this multicentre, nationwide study aimed to assess its clinical efficacy in closing complex anal fistula.", 'detailedDescription': 'Fifteen applications in 14 patients (3 male, 11 female) with complex anal fistulas treated in three tertiary hospitals in Austria were included between October 2018 and April 2021. Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells (Cx601 - Darvadstrocel, Alofisel®) was performed in each patient. Closure of the external fistula opening without secretion by finger compression was defined as success.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "14 patients with Crohn's disease and complex fistula got enrolled in this study.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged 18 and older who had a non-active or mildly active luminal CD with complex fistula with a maximum of two internal and three external fistulas\n\nExclusion Criteria:\n\n* rectovaginal fistulas\n* rectal and/or anal stenosis\n* active proctitis\n* diverting stomas\n* an abscess (\\<2cm) that was not drained at the fistula preperation visit'}, 'identificationModule': {'nctId': 'NCT05322057', 'briefTitle': "Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': "Efficacy of Cx601 (Darvadstrocel) for the Treatment of Perianal Fistulizing Crohn's Disease - a Prospective Nationwide Multicentre Study", 'orgStudyIdInfo': {'id': '1682/2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': "patients with Crohn's disease and complex perianal fistula", 'description': "14 patients with Crohn's disease refractory to standard treatment for complex perianal fistula got enrolled in this study.", 'interventionNames': ['Drug: Darvadstrocel']}], 'interventions': [{'name': 'Darvadstrocel', 'type': 'DRUG', 'otherNames': ['Alofisel'], 'description': 'Injection of 120 million allogeneic expanded adipose-derived mesenchymal stem cells around the fistula opening and around the fistula tract', 'armGroupLabels': ["patients with Crohn's disease and complex perianal fistula"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Stefan Riss, Prof.MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Vienna, Head of Pelvic Floor Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD can be shared just in anonymised form in case of an ethical agreement with other researches.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. univ.', 'investigatorFullName': 'Dr. Christopher Dawoud', 'investigatorAffiliation': 'Medical University of Vienna'}}}}