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| Name | Class |
|---|---|
| R&D Kanglin Biotech | OTHER |
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This is a non-randomized, open label, dose-escalation study to evaluate the safety and efficacy of KL002 in the treatment of advanced primary Parkinson's disease.
Condition or disease: Parkinson's Disease Intervention/treatment: Drug: KL002 Phase: NA
9 patients will be enrolled to this open-label dose escalation study to evaluate up to three dose levels of KL002 of three patients each. All patients will receive bilateral intraputaminal injections of KL002 through stereotactic brain surgery. The safety and potential clinical responses to KL002 will be assessed by clinical evaluations of Parkinson's disease, cognitive tests, laboratory blood tests and neuroimaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KL002 injection solution | Experimental | single dose, neurosurgically infused, bilaterally into the striatum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KL002 injection solution | Genetic | Neurosurgical delivery of KL002 to the brain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events | Safety and Tolerability of KL002 assessed by Treatment Emergent Adverse Events | Day 0 through month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson's Symptoms | Effect of KL002 on Parkinson's symptoms as recorded in subject diaries, neurological, motor, and non-motor assessments, quality of life surveys and changes to Parkinson's medications. | Day 0 through month 24 |
| PET Scan Imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Ruan, M.D. | Contact | +86 18858736151 | 11818236@zju.edu.cn | |
| Jiali Pu, Ph.D. | Contact | jialipu@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Baorong Zhang, M.D. | The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou, Zhejiang province, China, 310009 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310000 | 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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Relationship between KL002 distribution in the brain and change in dopamine expression as indicated in PET imaging.
| Day 0 through month 24 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |