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This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's Disease who have previously undergone deep brain stimulation or deep brain nucleus lesioning surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NouvNeu001 | Experimental | Low-dose and high-dose groups are set, with 5 subjects in each dose group. All eligible subjects who are screened and successfully enrolled will receive a single administration of NouvNeu001 injection during the surgical period, delivered via stereotactic neurosurgical injection into the bilateral putamen/striatum. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NouvNeu001 injection | Biological | NouvNeu001 injection is a Human Dopaminergic Progenitor Cell injection, administered as a single injection into the putamen/striatum region of the brain. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Adverse Events as Assessed by CTCAE V5.0 | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). | 48 weeks post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in the MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score, as well as MDS-UPDRS Parts I, II, III (off state and on state), and IV scores at 12, 24, 36, 48, 72, and 96 weeks after administration. | Change from baseline in the MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (Part I Score 0 ~ 52 + Part II Score 0 ~ 52 + Part III Score 0 ~ 72 + Part IV Score 0 ~ 24) at Weeks 12, 24, 36, 48, 72, and 96. A higher score indicates more severe symptoms or worse health. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Cai, Ph.D | Contact | 0086-027-59337986 | caimeng@iregene.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC | Hefei | Anhui | 230001 | China |
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| Weeks 12, 24, 36, 48, 72, and 96 |
| Changes from baseline in the Modified Hoehn and Yahr Staging at 12, 24, 36, 48, 72, and 96 weeks after administration | Change from baseline in the Modified Hoehn and Yahr Staging (0, 1, 1.5, 2, 2.5, 3, 4, 5) at Weeks 12, 24, 36, 48, 72, and 96. A higher Stage indicates more severe symptoms or worse health. | Weeks 12, 24, 36, 48, 72, and 96 |
| Changes from baseline in the Hamilton Depression Rating Scale (HAMD) score at 12, 24, 36, 48, 72, and 96 weeks after administration | Change from baseline in the Hamilton Depression Rating Scale (HAMD) score (0 ~ 53) at Weeks 12, 24, 36, 48, 72, and 96. A higher score indicates more severe symptoms or worse health. | Weeks 12, 24, 36, 48, 72, and 96 |
| Changes from baseline in the Parkinson's Disease Questionnaire (PDQ-39) score at 12, 24, 36, 48, 72, and 96 weeks after administration | Change from baseline in the Parkinson's Disease Questionnaire (PDQ-39) score (0 ~ 156) at Weeks 12, 24, 36, 48, 72, and 96. A higher score indicates more severe symptoms or worse health. | Weeks 12, 24, 36, 48, 72, and 96 |
| Changes from baseline in "off" time and "on" time at 12, 24, 36, 48, 72, and 96 weeks after administration | Change from baseline in the "off" time and "on" time at Weeks 12, 24, 36, 48, 72, and 96. The shorter the "on" time, the longer the "off" time indicates more severe symptoms or worse health. | Weeks 12, 24, 36, 48, 72, and 96 |
| Changes from preoperative baseline in the daily oral levodopa equivalent dose (LEDD) of patients at 12, 24, 36, 48, 72, and 96 weeks after administration | Change from baseline in the daily oral levodopa equivalent dose (LEDD) of patients at Weeks 12, 24, 36, 48, 72, and 96, A higher LEDD value indicates that the patient has used a larger dose of levodopa-class medications. | Weeks 12, 24, 36, 48, 72, and 96 |
| Changes from baseline in Total Electrical Energy Delivered (TEED) at 12, 24, 36, 48, 72, and 96 weeks after administration | Change from baseline in Total Electrical Energy Delivered (TEED) at Weeks 12, 24, 36, 48, 72, and 96. A higher TEED value indicates that the patient has received a greater amount of electrical stimulation | Weeks 12, 24, 36, 48, 72, and 96 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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