Safety and Efficacy Study of KL002 in the Treatment of Advanced Primary PD
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, KL002, Putamen, Stereotactic brain surgery
Eligibility Criteria
Inclusion Criteria: Males/females between 40 and 70 years (inclusive) Diagnosed with idiopathic Parkinson's disease, Hoehn and Yahr stage 4 and 5 Disease duration at least 5 years MDS UPDRS Part III (total motor) score ≥ 25 and a maximum of 60 in the OFF state Good compliance and can complete all follow-up in accordance with the protocol requirements Exclusion Criteria: Prior brain surgery including deep brain stimulation or abnormal brain imaging. Presence of depression as measured by Hamilton Depression Scale ≥20 History of brain injury or central nervous system infection. Cognitive impairment score<26 on MoCA and ≤ 20 on MMSE dementia scale Evidence of significant medical or psychosis, such as dementia, psychosis, and a history of drug abuse Atypical or secondary parkinsonism, including but not limited to symptoms believed to be due to trauma, brain tumor, infection, cerebrovascular disease, other neurological disease, or to drugs, chemicals, or toxins. Prior gene therapy. Chronic immunosuppressive therapy, including chronic steroids, immunotherapy, cytotoxic therapy and chemotherapy Any other conditions that the investigator believed unsuitable for participation in this study.
Sites / Locations
- Second Affiliated Hospital of Zhejiang University School of Medicine
Arms of the Study
Arm 1
Experimental
KL002 injection solution
single dose, neurosurgically infused, bilaterally into the striatum