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The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment. The main questions it aims to answer are:
What medical problems do participants have when transplanting NouvNeu001 into bilateral putamen using stereotactic neurosurgery? Does injection of NouvNeu001 improve the motor function and non-motor function in participants?
Participants will:
Be injectioned the NouvNeu001 into bilateral putamen using stereotactic neurosurgery.
Take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NouvNeu001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Dopaminergic Progenitor Cells | Biological | Single injection of Human Dopaminergic Progenitor Cells into the putamen of brain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). | Enrollment to 96 weeks post-transplant. |
| Measure | Description | Time Frame |
|---|---|---|
| The Motor Function and Non-motor Function | Changes in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I-IV Score from baseline. A higher score indicates more severe symptoms or worse health. | Baseline to 48 weeks and 96 weeks post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Positron Emission Tomography Imaging | Change in uptake value from baseline using positron emission tomography (PET). | Baseline to 48 weeks post-transplant. |
| Dopamine Metabolism | Change in the levels of dopamine and its metabolites from baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Cai | Contact | 86-027-59338180 | caimeng@iregene.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College Hust | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Baseline to 48 weeks post-transplant. |
| D009069 | Movement Disorders |