Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 8:29 AM
Study NCT ID:
NCT07099066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Generation of Cell Banks and Biomarker Isolation From Patients With Amyotrophic Lateral Sclerosis (ALS) (HCD-SLA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017218', 'term': 'Cordocentesis'}], 'ancestors': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019152', 'term': 'Paracentesis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-07-25', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cell banking', 'timeFrame': '8 months', 'description': 'Number of cell batches cryopreserved that meet predefined quality criteria (cell viability ≥ 80%, absence of mycoplasma). Data will be summarized as percentage of compliant batches over total batches produced.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amyotrophic Lateral Sclerosis (ALS)'], 'conditions': ['Amyotrophic Lateral Sclerosis (ALS)']}, 'descriptionModule': {'briefSummary': 'The aim of this research is to establish different cell banks from patients with amyotrophic lateral sclerosis (ALS).', 'detailedDescription': 'The objective of this research is to:\n\n* Create banks of skin fibroblasts from skin biopsy samples\n* Create banks of urine-derived cells (UDCs) from urine samples\n* Build a collection of blood samples to enable isolation of biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ALS patients who are part of a cohort from the ALS Center of Toulouse University Hospital and are treated at that hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects over 18 years old;\n* Subjects who have given their consent and signed an informed, free and express consent form;\n* Subjects with diagnosed ALS;\n* Subjects affiliated to or benefiting from a social security scheme.\n\nExclusion Criteria:\n\n* Subjects with contraindications to the collection of biological samples (blood, skin, urine).\n* Subjects undergoing treatment likely to affect hemostasis (anticoagulants, platelet anti-aggregants, etc.) in the month prior to inclusion and during the study;\n* Subjects with hereditary or acquired haemostasis disorders;\n* Subjects who have undergone physical treatment (radiotherapy, etc.) on the area to be biopsied in the last 6 months;\n* Lidocaine-intolerant subjects;\n* Subjects who have reached the age of majority and are subject to a protective measure or are unable to express their consent.'}, 'identificationModule': {'nctId': 'NCT07099066', 'acronym': 'HCD-SLA', 'briefTitle': 'Generation of Cell Banks and Biomarker Isolation From Patients With Amyotrophic Lateral Sclerosis (ALS) (HCD-SLA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Human Cell Design'}, 'officialTitle': 'Generation of Skin Fibroblast Banks, Urine-derived Cells and Biomarker Isolation From Patients With Amyotrophic Lateral Sclerosis (Als)', 'orgStudyIdInfo': {'id': '2025-A00776-43'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALS patients', 'interventionNames': ['Other: sampling blood']}], 'interventions': [{'name': 'sampling blood', 'type': 'OTHER', 'description': '3 types of sampling : urine, skin and blood.', 'armGroupLabels': ['ALS patients']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Human Cell Design', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}