Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-05 @ 6:15 PM
Study NCT ID:
NCT06636032
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula
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': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adverse events of grade ≥ 2 at 6 months', 'timeFrame': '6 months after injection', 'description': 'Number of adverse events of grade ≥ 2 related to the experimental treatment (CellReady®) or related to surgical/medical procedures,'}, {'measure': 'Efficacy of AdMSC by clinical evaluation at 6 months', 'timeFrame': '6 months after injection', 'description': 'This evaluation will be measured by the presence or absence of flow through the internal or external orifice see in anoscopy and through the external orifice'}, {'measure': 'Efficacy of AdMSC by radiological evaluation at 6 months', 'timeFrame': '6 months after injection', 'description': 'This evaluation will be measured by disappearance of fistula tract or fistula tract present but inactive.'}], 'secondaryOutcomes': [{'measure': 'Safety at 1 and 3 and 6 months', 'timeFrame': '1, 3 and 6 months after injection', 'description': 'adverse effects will be assessed'}, {'measure': 'Efficacy of AdMSC by clinical evaluation 1 and 3 months', 'timeFrame': '1 and 3 months after injection', 'description': 'This evaluation will be measured by the presence or absence of flow through the internal or external orifice see in anoscopy and through the external orifice'}, {'measure': 'Efficacy of AdMSC by biological evaluation', 'timeFrame': '1, 3 and 6 months after injection', 'description': 'complete blood count , platelets, C-reactive protein (CRP) , liver enzyme profile, Prothrombin level (TP), activated clotting time (ACT), albumin, ferritinemia will be measured in blood samples'}, {'measure': 'Change from Baseline in quality of life', 'timeFrame': '1, 3 and 6 months after injection', 'description': 'Evaluation of quality of life by CAF QoL'}, {'measure': 'Change from Baseline in disease activity', 'timeFrame': '1, 3 and 6 months after injection', 'description': 'Evaluation of quality of life by Harvey-Bradshaw Index'}, {'measure': 'Change from Baseline in perianal disease activity', 'timeFrame': '1, 3 and 6 months after injection', 'description': 'Evaluation by perianal disease activity index (PDAI) . This index evaluate the presence of a fistula, the presence of pain and its impact on activity, the characteristics of the APL, the impact on the sexual activity'}, {'measure': 'Change from Baseline in lesions', 'timeFrame': '1, 3 and 6 months after injection', 'description': 'Evaluation by Cardiff classifcation . The creation of subclasses of anoperineal lesions allowing the comparison of superimposable groups in therapeutic trials. This classification allows a standardized and precise description of lesions.'}, {'measure': 'Change from Baseline in anal incontinence', 'timeFrame': '1, 3 and 6 months after injection', 'description': 'Evaluation by Wexner anal incontinence score: score to quickly and simply assess the severity of anal incontinence.'}, {'measure': 'Change from Baseline in patient symptoms', 'timeFrame': '1, 3 and 6 months after injection', 'description': 'Evaluation by Allan score: score used to assess patient symptoms and assess the impact of treatment on perineal lesions.'}, {'measure': 'tryptophan metabolists', 'timeFrame': '3 and 6 months after injection', 'description': 'tryptophan metabolists are measured by high pressure liquid chromatography coupled with tandem mass spectrometry'}, {'measure': 'faecal microbiota', 'timeFrame': '3 and 6 months after injection', 'description': 'faecal microbiota is analysed by Illumina Mi-Seq'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Crohn's disease", 'perianal fistula', 'regenerative medicine', 'immunomodulation', 'allogeneic adipose-derived stem cell'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "Perianal fistulas are in the forefront (42 to 72, 4%) of morbid complication of Crohn's disease, affecting nearly one- third of patients and complicating abscesses in 35-48% of cases. The current treatment is based on the combination of drainage (proctologic and surgical), and biologics techniques, but the failure rate varies from 30 to 80%. Actually, innovative cell therapy procedures are validated by Cell-Easy with the use of allogenic mesenchymal stem cells for the immunomodulatory, anti-inflammatory, angiogenic and trophic properties (CellReady®) and represent a promising option in the treatment of perianal fistulas associated with Crohn's disease. This phase I/II study is designed to evaluate the treatment of complex perianal fistulas associated with Crohn's disease, after failure of conventional treatment by injection of allogeneic cultured adipose-derived stromal cell (AdMSC) into the fistula.", 'detailedDescription': "The injection of adipose stromal cells is currently evaluated in clinical studies for repair-damaged tissues in various diseases (limb ischemia, osteoarthritis, systemic slerosis...). Immunoregulatory and anti-inflammatory properties of AdMSC's are responsible for accelerating healing and represents an innovative approach to treat perianal fistulas associated with Crohn's disease.\n\nThis phase I/II study is designed to evaluate the treatment of complex perianal fistulas associated with Crohn's disease, after failure of conventional treatment by injection of AdMSC (CellReady®) into the fistula.\n\nDifferent doses of AdMSC will be tested for a dose escalation (5.10\\*7 and 10.10\\*7 cells) and injected in the in the wall of the fistula."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over 18 years old,\n* Patients who signed the informed consent,\n* Patient affiliated to a social security system,\n* Controlled luminal Crohn's disease characterized by an Harvey-Bradshaw score less or equal than 8 and diagnosed on clinical, endoscopic, histological and/or radiological criteria for more than 3 months,\n* Colonoscopy less than a year old without ulcer in the rectum,\n* Presence of complex chronic perianal fistula with a maximum of two internal ports and three external ports,\n* Patient treated with a combined treatment (drainage on setons + anti-TNFα) and who failed conventional treatment after 6 months and whose intraluminal disease (intestinal damage) is controlled\n\nExclusion Criteria:\n\n* Refusal of the patient to participate in the study,\n* Positive QuantiFERON test,\n* Patient with transplanted organ,\n* History of cancer in the last five years or lympho-proliferative disease,\n* Persistent bacterial or viral infection,\n* Patient with a contraindication to MRI,\n* Known allergy to Gadolinium,\n* Known allergy to Albumine,\n* End-stage organ failure,\n* Pregnant or breastfeeding women,\n* Women of childbearing age without effective contraception throughout the duration of the study,\n* Patient under judicial protection, under guardianship or curatorship.\n* Patient previously treated with ALOFISEL®"}, 'identificationModule': {'nctId': 'NCT06636032', 'acronym': 'ALLOFIST', 'briefTitle': "Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': "Dose Escalation of Allogeneic Adipose Derived Stroma/Stem Cells for the Treatment of Crohn's Fistula:a Phase I/II Clinical Study", 'orgStudyIdInfo': {'id': 'RC31/13/7030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AdMSC (CellReady®)', 'description': 'Different doses of AdMSC will be tested for a dose escalation (5.10\\*7 and 10.10\\*7 cells) and injected in the in the wall of the fistula', 'interventionNames': ['Drug: AdMSC (CellReady®)']}], 'interventions': [{'name': 'AdMSC (CellReady®)', 'type': 'DRUG', 'otherNames': ['AdMSC'], 'description': 'At day 0, patients will have AdMSC injections. Patients will be followed-up for 6 months', 'armGroupLabels': ['AdMSC (CellReady®)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Etienne BUSCAIL, MD', 'role': 'CONTACT', 'email': 'buscail.e@chu-toulouse.fr', 'phone': '05 61 32 23 73', 'phoneExt': '+33'}], 'facility': 'Toulouse Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Etienne BUSCAIL, MD', 'role': 'CONTACT', 'email': 'buscail.e@chu-toulouse.fr', 'phone': '05 61 32 23 73', 'phoneExt': '+33'}, {'name': 'Louis BSUCAIL, MD', 'role': 'CONTACT', 'email': 'buscail.l@chu-toulouse.fr', 'phone': '05 61 32 33 98', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Etienne BUSCAIL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toulouse Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}