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| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments primarily manage symptoms but do not halt or reverse neuronal loss. Cellular replacement therapy has emerged as a potential strategy to restore dopaminergic function and address the underlying neuronal deficits. This study aims to evaluate the safety, feasibility, and efficacy of transplanting dopaminergic neurons into the brain to improve motor function and quality of life in patients with advanced Parkinson's disease.
Patients with Parkinson's disease will be treated with allogenic induced pluripotent stem cell-derived dopamine progenitor cells (iPSC-DAPs). These cells will be transplanted directly into the striatum to restore dopamine-producing capacity. Patients will be evaluated at 1, 3, 6, 9 and 12 months after transplantation for safety, feasibility, and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose ALC01 therapy | Experimental | Stereotactic Intracerebral Injection of iPSC-DAPs into the putamen on each side of the brain |
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| High Dose ALC01 therapy | Experimental | Stereotactic Intracerebral Injection of iPSC-DAPs into the putamen on each side of the brain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALC01 therapy | Biological | A single dose of iPSC-DAPs will be administered into the putamen on each side of the brain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and servility of Treatment-Emergent Adverse Events | Incidence of adverse event (AE), serious adverse event(SAE) is defined as the composite of number and severity of adverse events, regardless of causality, clinical laboratory abnormalities, clinical meaningful changes from baseline | From baseline to 12 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in motor function | Changes in motor function that measured by Movement and Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III. TheMDA- UPDRS Part III score ranges from 0 to 132, with higher score indicating greater disability | From baseline to 12 months post surgery |
| Changes in the Hoehn and Yahr scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Yan, PhD, MD | Contact | +86 13868137422 | yan.feng7@163.com | |
| Jiemin Zhou, MD | Contact | 7789262190 | Jo.Zhou@icamuno.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao Chen, PhD, MD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Hoehn and Yahr scale is used to provide a general estimate of clinical function of PD patients, combining functional deficits (disability) and objective signs (impairment). The Hoehn and Yahr score ranges from 0 to 5, with higher score indicating higher dysfunction of PD patients |
| From baseline to 12 months post surgery |
| Changes in quality of life (QoL) | Measured by Parkinson's Disease Quality of Life Rating Scale (PDQ-39) from baseline to 12 months post surgery. PDQ-39 score ranges from 0 to 156 and provides the evidence of the quality of life of a PD patient. The higher the score, the lower the quality of life of PD patients. | From baseline to 12 months post surgery |
| Change in PD medication usage | Change in the Parkinson's disease medication usage as defined by the levodopa equivalent daily dose (LEDD) | From baseline to 12 months post surgery |
| 18-F DAT PET uptake | Changes in putamen 18F DAT PET uptake that measured by PET/CT | Baseline, 6 and 12 months post surgery |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |