Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-27 @ 9:11 PM
Study NCT ID:
NCT07113795
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-11
First Post:
2025-05-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on the Integration of Traditional Chinese Medicine Virtual Hanging Therapy With Mesenchymal Stem Cells for the Treatment of Crohn's Disease-Associated Anal Fistula.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD anal fistula healing rate', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': "Post-treatment healing rate of Crohn's disease-related anal fistula, defined as clinical closure of all external fistula openings in patients, combined with MRI-confirmed fistula tract healing."}], 'secondaryOutcomes': [{'measure': 'CDAI', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': "A clinical scoring system to quantify disease activity in Crohn's disease (CD) patients, integrating symptoms (e.g., abdominal pain, diarrhea) and laboratory parameters (e.g., hemoglobin, ESR).0\\~600(\\~600, theoretically no upper limit).Higher scores indicate worse disease activity (poorer outcome)."}, {'measure': 'PDAI', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': "A standardized tool to assess the severity of perianal complications (e.g., fistulas, abscesses) in Crohn's disease, combining clinical symptoms (e.g., pain, discharge) and imaging findings.0-20.Higher scores indicate worse perianal disease activity (poorer outcome)."}, {'measure': 'IBDQ', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': 'A validated patient-reported outcome measure evaluating the quality of life in IBD patients across physical, emotional, and social domains.32-224.Higher scores indicate better health-related quality of life (better outcome).'}, {'measure': 'Van Assche', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': 'An MRI-based scoring system for perianal fistulas, grading anatomical complexity (e.g., fistula branches, abscesses) and inflammatory activity to guide therapeutic strategies.0-12.Higher scores indicate more severe perianal fistulizing disease on MRI (poorer outcome).'}, {'measure': 'VAS', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': 'A unidimensional pain assessment tool where patients mark their pain intensity on a 10-cm line (0=no pain, 10=worst pain).'}, {'measure': 'Wexner', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': 'A validated scoring system to evaluate constipation severity based on stool frequency, straining, incomplete evacuation, and associated symptoms (e.g., abdominal bloating).0-20.Higher scores indicate worse fecal incontinence severity (poorer outcome).'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': 'A nonspecific inflammatory marker reflecting the rate at which red blood cells settle in a tube over one hour; elevated in infections, autoimmune diseases, or chronic inflammation.'}, {'measure': 'Fecal Calprotectin', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': 'A stool biomarker of intestinal inflammation, reflecting neutrophil activity; used to differentiate inflammatory bowel disease (IBD) from functional gastrointestinal disorders.'}, {'measure': 'C-reactive Protein (CRP)', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': 'An acute-phase protein synthesized by the liver; elevated serum levels indicate systemic inflammation, infection, or tissue damage.'}, {'measure': 'Anorectal Manometry', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': 'Primary outcome measures: Anal Resting Pressure (basal sphincter pressure at rest; normal 40-80mmHg; \\<40mmHg=incontinence risk), Maximum Anal Squeeze Pressure (peak voluntary squeeze; normal 100-200mmHg; \\<100mmHg=sphincter impairment), Recto-anal Pressure Gradient (rectal-anal pressure difference; normal -20 to -50mmHg; positive=dyssynergic defecation). Secondary: First Sensation Volume (minimal rectal balloon volume for sensation; normal 10-30mL; \\>30mL=hyposensitivity), Urge Volume (volume for sustained defecation urge; normal 40-80mL; \\>80mL=severe sensory dysfunction), Max Rectal Volume (max tolerated distension; normal 120-200mL; \\<120mL=low compliance), Balloon Expulsion Time (time to expel 50mL balloon; normal ≤60s; \\>60s=pelvic dyssynergia), Anal High Pressure Zone Length (axial sphincter length; normal 2.0-4.0cm; \\<2.0cm=anatomical defect).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Traditional Chinese Medicine', 'Virtual Hanging therapy', 'Mesenchymal Stem Cells', "Crohn's Disease-Associated Anal Fistula", 'Randomized Controlled Trial'], 'conditions': ['Crohn's Disease With Perianal Fistulas']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of TCM virtual hanging therapy combined with mesenchymal stem cellsin the treatment of CD anal fistula. To establish the standard of clinical diagnosis and treatment and thestandard procedure of operation for the treatment of CD anal fistula by virtual hanging therapy combinedwith mesenchymal stem cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSigned informed consent form.\n\nDiagnosis of Crohn's disease (CD) confirmed at least 6 months prior to screening, based on the Chinese Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2018, Beijing).\n\nCrohn's Disease Activity Index (CDAI) score ≤220, indicating inactive or mildly active CD.\n\nPresence of complex anal fistula confirmed by clinical and MRI evaluation.\n\nAge 18-60 years (inclusive), regardless of sex.\n\nNegative serum/urine pregnancy test for women of childbearing potential; all participants must agree to use effective contraception during and for 6 months after the trial.\n\nGood general health status confirmed by medical history and relevant examinations.\n\nExclusion Criteria:\n\nCDAI \\>220 or requiring immediate treatment for active CD.\n\nPatients with rectal/anal stenosis or active proctitis (due to procedural limitations).\n\nPresence of abscess \\>2 cm unless treated ≥2 weeks prior to the trial.\n\nHistory of fistula surgery (except drainage or seton placement), concurrent need for perianal surgery unrelated to fistula, or anticipated need for such surgery within 24 weeks post-treatment.\n\nSystemic steroid therapy within 4 weeks prior to screening.\n\nAbnormal laboratory results:\n\nLiver function: Total bilirubin ≥1.5×ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5×ULN.\n\nRenal function: Creatinine clearance \\<60 mL/min or serum creatinine ≥1.5×ULN (measured or calculated by Cockcroft-Gault formula).\n\nCurrent or history of malignancy (including fistula-related carcinoma).\n\nSevere, progressive, or uncontrolled hepatic, hematologic, gastrointestinal (excluding CD), endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral diseases.\n\nHIV/syphilis antibody positivity, active HCV/HBV infection, or active tuberculosis.\n\nKnown allergy to antibiotics or trial-related agents (e.g., penicillin, streptomycin, gentamicin, aminoglycosides, human serum albumin, human platelet lysate, DMEM cell culture medium, or bovine-derived materials).\n\nIntolerance to anesthesia or contraindications to MRI scanning (e.g., pacemaker, hip prosthesis, severe claustrophobia, gadolinium allergy).\n\nPregnancy, lactation, or refusal to use effective contraception during and for 6 months post-trial.\n\nMajor surgery or severe trauma within the past 6 months.\n\nHistory of alcohol/drug abuse within 6 months prior to enrollment.\n\nUse of investigational drugs within 12 weeks (84 days) prior to screening.\n\nInability to comply with the study protocol or other conditions deemed unsuitable by investigators."}, 'identificationModule': {'nctId': 'NCT07113795', 'acronym': 'VH-MSC-CDAF', 'briefTitle': "Clinical Study on the Integration of Traditional Chinese Medicine Virtual Hanging Therapy With Mesenchymal Stem Cells for the Treatment of Crohn's Disease-Associated Anal Fistula.", 'organization': {'class': 'NETWORK', 'fullName': 'The Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine'}, 'officialTitle': "Clinical Study on the Integration of Traditional Chinese Medicine Xu Gua Therapy With Mesenchymal Stem Cells for the Treatment of Crohn's Disease-Associated Anal Fistula.", 'orgStudyIdInfo': {'id': 'BE2022674'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Association Group', 'description': 'receiving a combination of TCM dummy therapy and mesenchymal stem cell injection therapy', 'interventionNames': ['Procedure: TCM dummy therapy combined with mesenchymal stem cell injection therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dummy Line Therapy Group', 'description': 'treated solely with dummy line therapy', 'interventionNames': ['Procedure: Dummy Line Therapy Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MSC Group', 'description': 'administered only mesenchymal stem cell injection therapy', 'interventionNames': ['Procedure: MSC Group']}], 'interventions': [{'name': 'TCM dummy therapy combined with mesenchymal stem cell injection therapy', 'type': 'PROCEDURE', 'description': 'Combines TCM dummy therapy with mesenchymal stem cell injection, integrating traditional local stimulation and modern stem cell regenerative mechanisms.', 'armGroupLabels': ['Association Group']}, {'name': 'Dummy Line Therapy Group', 'type': 'PROCEDURE', 'description': 'Utilizes traditional thread-embedding techniques, placing specialized threads at specific sites to effectively drain inflammatory exudates and necrotic materials.', 'armGroupLabels': ['Dummy Line Therapy Group']}, {'name': 'MSC Group', 'type': 'PROCEDURE', 'description': 'Administers mesenchymal stem cell injections directly to target areas, leveraging their differentiation and anti-inflammatory properties to enhance tissue repair.', 'armGroupLabels': ['MSC Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Hospital of Traditional Chinese Medicine (Affiliated Hospital of Nanjing University of Chinese Medicine)', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is a single-center study without involvement of other institutions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Anorectal Center of Nanjing Hospital of Traditional Chinese Medicine', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}