Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:58 AM
Study NCT ID:
NCT07467733
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001259', 'term': 'Ataxia'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MDS-UPDRS', 'timeFrame': '92 weeks', 'description': "Change in motor symptoms measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III - Motor Examination Range: 0-132 Where 132 is the worst motor impairment; 0 - the best motor impairment"}, {'measure': 'SARA', 'timeFrame': '92 weeks', 'description': 'Change in motor function as measured by the Scale for the Assessment and Rating of Ataxia (SARA) Range: 0-40 40 - the most severe ataxia; 0 - the mildest'}], 'secondaryOutcomes': [{'measure': 'ICARS', 'timeFrame': '92 weeks', 'description': 'Change in neurological function measured by the International Cooperative Ataxia Rating Scale (ICARS) Range: 0-100 100 is the worst neurological impairment; 0 - the best'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ataxia', 'mesenchymal stem cells', 'exosomes'], 'conditions': ['Spinocerebellar Ataxia - All Sub-types']}, 'descriptionModule': {'briefSummary': 'This clinical study aims to evaluate the safety and preliminary therapeutic potential of mesenchymal stem cell-derived therapies in patients diagnosed with spinocerebellar palsy. The investigational treatment includes neuroinduced mesenchymal stem cells and their derived exosomes administered via intravenous and intranasal infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of spinocerebellar palsy confirmed by neurological examination; Disease duration ≤10 years; Ability to provide informed consent.\n\nExclusion Criteria:\n\nSevere systemic illness; Active infection; History of malignancy within 5 years; Prior stem cell therapy; Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT07467733', 'acronym': 'NEURO-SCP', 'briefTitle': 'Evaluation of the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocells Medical'}, 'officialTitle': 'Phase I/II Randomized Controlled Study Evaluating the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy', 'orgStudyIdInfo': {'id': 'Bio120006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Neuroinduced Mesenchymal Stem Cells', 'interventionNames': ['Drug: Intrathecal infusion']}, {'type': 'EXPERIMENTAL', 'label': 'Mesenchymal Stem Cell Derived Exosomes', 'interventionNames': ['Drug: Intranasal infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline solution', 'interventionNames': ['Drug: Intranasal infusion']}], 'interventions': [{'name': 'Intrathecal infusion', 'type': 'DRUG', 'description': '200,000,000 neuroinduced mesenchymal stem cells administered via intravenous infusion.', 'armGroupLabels': ['Neuroinduced Mesenchymal Stem Cells']}, {'name': 'Intranasal infusion', 'type': 'DRUG', 'description': 'Intranasal infusion of purified exosomes derived from mesenchymal stem cells', 'armGroupLabels': ['Mesenchymal Stem Cell Derived Exosomes', 'Saline solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-797', 'city': 'Warsaw', 'country': 'Poland', 'contacts': [{'name': 'Anita Gerder', 'role': 'CONTACT', 'email': 'info@biocellsmedical.com', 'phone': '+48223074882'}], 'facility': 'BioCells Medical', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Andrei Peskau', 'role': 'CONTACT', 'email': 'info@biocellsmedical.com', 'phone': '+48452365311'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocells Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Biocells Medical', 'investigatorFullName': 'Andrei Peskau', 'investigatorAffiliation': 'Biocells Medical'}}}}