Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT07145502
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Outcomes of Cellular and Exosome-based Therapies in Autoinflammatory and Post-infectious Neuroinflammatory Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-06-08', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in neurological symptom severity', 'timeFrame': 'from enrollment to the end of treatment at 8 weeks', 'description': 'Change in neurological symptom severity as measured by the National Institutes of Health Stroke Scale (NIHSS; range 0-42, higher scores indicate greater severity)'}], 'secondaryOutcomes': [{'measure': 'Change in serum cytokine levels', 'timeFrame': 'From the enrolment till the end of the treatment (8 weeks)', 'description': 'IL-6, TNF-α, pg/mL'}, {'measure': 'Change in patient-reported quality of life', 'timeFrame': 'From the enrolment to the end of the treatment (8 weeks)', 'description': 'EQ-5D (range: 5-25, lower scores indicate better health-related quality of life)'}, {'measure': 'Change in patient-reported quality of life', 'timeFrame': 'From the enrolment till the end of the treatment (8 weeks)', 'description': 'SF-36 (range: 0-100, higher scores indicate better health-related quality of life)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autoimmune encephalitis', 'Early-stage panencephalitis'], 'conditions': ['Autoimmune Encephalitis', 'Early-stage Panencephalitis', 'Neuroinflammatory Demyelination']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-randomized, observational registry study evaluating the clinical outcomes of patients with autoimmune or post-infectious neuroinflammatory syndromes receiving stem cell-derived biologics (including mesenchymal stem cells and exosomes) at Biocells Medical clinics. The study aims to track improvements in neurological function, inflammatory biomarkers, and patient-reported quality of life following individualized regenerative interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include pediatric, adult, and older adult patients aged 6 to 70 years who present with clinically confirmed or strongly suspected neuroinflammatory conditions of autoimmune or post-infectious origin. These include but are not limited to autoimmune encephalitis, post-viral encephalopathies (e.g., following measles, CMV, EBV, SARS-CoV-2), early-stage panencephalitis, and chronic neuroimmune syndromes such as ME/CFS and long COVID with CNS involvement.\n\nPatients are eligible for inclusion if they have a persistent neuroinflammatory or neurocognitive condition that has not responded adequately to standard therapies or has relapsed. Diagnostic confirmation may include MRI findings, CSF analysis, neuropsychological testing, and immunological profiling (e.g., autoantibodies, cytokines).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Age 6-70\n\n * Diagnosis of one of the eligible syndromes by neurologist or immunologist\n * Unresponsive or partially responsive to conventional therapy\n * Informed consent provided\n\nExclusion Criteria:\n\n* • Active malignancy\n\n * Severe systemic infection\n * Contraindications to IV biologics'}, 'identificationModule': {'nctId': 'NCT07145502', 'briefTitle': 'Monitoring of Outcomes of Cellular and Exosome-based Therapies in Autoinflammatory and Post-infectious Neuroinflammatory Syndromes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocells Medical'}, 'officialTitle': 'Monitoring of Outcomes of Cellular and Exosome-based Therapies in Autoinflammatory and Post-infectious Neuroinflammatory Syndromes', 'orgStudyIdInfo': {'id': 'Bio120001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'B1', 'description': '* Age 6-70\n* Diagnosis of one of the eligible syndromes by neurologist or immunologist\n* Unresponsive or partially responsive to conventional therapy\n* Informed consent provided', 'interventionNames': ['Biological: Allogeneic MSC infusions (IV)']}], 'interventions': [{'name': 'Allogeneic MSC infusions (IV)', 'type': 'BIOLOGICAL', 'otherNames': ['MSC-derived exosomes (IV or intranasal)', 'Supportive immunomodulatory agents'], 'description': 'Optional T-reg therapy (experimental/compassionate-use basis)', 'armGroupLabels': ['B1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-234', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Biocells Medical', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocells Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}