Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT06978920
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR201 in the Treatment of Subjects With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events.', 'timeFrame': 'Within 24 weeks post-transplantation', 'description': 'Safety and tolerability'}], 'secondaryOutcomes': [{'measure': "Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part III, in comparison with baseline values.", 'timeFrame': 'Within 24 months post-transplantation', 'description': 'Minimum score: 0; Maximum score: 132; Higher scores mean a worse outcome.'}, {'measure': "Assessment of changes in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I,II,IV, in comparison with baseline values.", 'timeFrame': 'Within 24 months post-transplantation', 'description': 'Higher scores mean a worse outcome.'}, {'measure': 'Assessment of changes in Hoehn & Yahr scale in comparison with baseline values.', 'timeFrame': 'Within 24 months post-transplantation', 'description': 'Comprehensive clinical assessment for examining the improvements in Parkinson disease.'}, {'measure': 'Assessment of changes in Hamilton Depression Scale (HAMD)-17 in comparison with baseline values.', 'timeFrame': 'Within 24 months post-transplantation', 'description': 'Comprehensive clinical assessment for examining the improvements in mental state.'}, {'measure': 'Assessment of changes in Hamilton Anxiety Scale (HAMA)-14 in comparison with baseline values.', 'timeFrame': 'Within 24 months post-transplantation', 'description': 'Comprehensive clinical assessment for examining the improvements in mental state.'}, {'measure': "Assessment of changes in Parkinson's Disease Questionnaire-39 (PDQ-39) in comparison with baseline values.", 'timeFrame': 'Within 24 months post-transplantation', 'description': 'Comprehensive clinical assessment for examining the improvements in activity of daily living.'}, {'measure': "Bilateral putamen standardized uptake value as demonstrated on positron emission tomography(PET) compared with baseline in the 'off' state.", 'timeFrame': 'Within 24 months post-transplantation', 'description': 'Evidence of cell survival'}, {'measure': 'Patient L-dopa equivalent dose compared with baseline.', 'timeFrame': 'Within 24 months post-transplantation', 'description': 'Measure of dopaminergic drug dose'}, {'measure': 'Incidence and severity of adverse events.', 'timeFrame': 'Within 24 months post-transplantation', 'description': 'Safety and tolerability'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to evaluate the safety, tolerability and preliminary efficacy that NCR201 has on Parkinson's disease (PD) patients.", 'detailedDescription': 'Parkinson\'s disease (PD) is a common neurodegenerative disease in the middle-aged and elderly. It is the "third killer" of the middle-aged and elderly after tumors and cardiovascular and cerebrovascular diseases. Its main clinical manifestations are resting tremor, reduced voluntary movement, muscle rigidity, postural reflex impairment, and autonomic dysfunction, which seriously affect patients\' work ability and quality of life. It is estimated that nearly 100,000 people in China become new Parkinson\'s patients every year. Experts from the World Health Organization predict that the number of Parkinson\'s patients in China will reach 5 million in 2030, which will be more than half of the world\'s total. As the disease progresses, the symptoms of Parkinson\'s patients will become increasingly severe. The high prevalence and high disability rate of Parkinson\'s disease bring heavy burdens to individuals, families, and society.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ages between 40 and 75 years;\n* Diagnosed to be Parkinson's disease according to Parkinson's disease diagnostic criteria;\n* Disease history over 5 years;\n* Stable dose of dopamine treatment;\n* Able to undergo PET/CT/MRI detection;\n\nExclusion Criteria:\n\n* Patients who have previously undergone brain surgery;\n* Past use of stem cell therapy or participation in stem cell clinical research;\n* Cognitive impairment;\n* History of mental disorders;\n* Patients with other serious systemic diseases;\n* Past or current metastatic malignant tumors."}, 'identificationModule': {'nctId': 'NCT06978920', 'briefTitle': "A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR201 in the Treatment of Subjects With Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Nuwacell Biotechnologies Co., Ltd.'}, 'officialTitle': "A Phase I, Open Label, Single Arm, Dose Escalation and Dose Expansion Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Human Induced Pluripotent Stem Cell Derived Dopaminergic Progenitor Cells (NCR201) Injection in the Treatment of Subjects With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'NCR201-2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose', 'description': 'MRI-guided bilateral stereotactic cell implantation', 'interventionNames': ['Drug: Allogeneic dopaminergic neural precursor cell(NCR201)']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose', 'description': 'MRI-guided bilateral stereotactic cell implantation', 'interventionNames': ['Drug: Allogeneic dopaminergic neural precursor cell(NCR201)']}], 'interventions': [{'name': 'Allogeneic dopaminergic neural precursor cell(NCR201)', 'type': 'DRUG', 'description': 'Bilateral implantation', 'armGroupLabels': ['High Dose', 'Low Dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'The First Affiliated Hospital of USTC', 'role': 'CONTACT', 'email': 'ahslyyxcb@163.com', 'phone': '0551-96512'}], 'facility': 'The First Affiliated Hospital of USTC', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nuwacell Biotechnologies Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}