the safety, tolerability and efficacy of nouvneu001 for parkinson's disease

Conditions: Parkinson Disease

Summary: 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.

this is a multi-center, single arm, and open label trial. the nouvneu001 will be transplanted into bilateral putamen/striatum using stereotactic neurosurgery. subjects will take immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.

Eligibility criteria:
inclusion criteria: * age 50-75 years old, male or female * able to understand the rationale of the clinical trial and sign informed consent form (icf) * diagnosis of parkinson's disease in accordance with the mds clinical diagnostic criteria for parkinson's disease (2015) * diagnosis of parkinson's disease made between 4 to 20 years ago * medically suitable for neurosurgery under anesthesia and able to participate in magnetic resonance imaging (mri) and positron emission tomography (pet) scan. * hoehn-yahr staging for "off" episodes is 2.5 to 4 * the mds-updrs part iii (mds-updrs-iii) score in the "off" state \> 35, and positive for the acute levodopa challenge test (alct) * acceptable laboratory test results during screening and prior to transplantation exclusion criteria: * atypical parkinsonism * patients who have had previous pallidotomy, deep brain stimulation (dbs) surgery, striatal or extrapyramidal surgery, brain stereotaxy or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's participation in this study * patients who have a previous head ct/mri examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery. * patients with a history of severe cardiovascular and cerebrovascular diseases * patients with a history of malignant tumors * patients who have had previous cellular therapy * patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to screening, or who cannot temporarily suspend anti-platelet agents or other anti-coagulant medications for at least 5 days before surgery * patients with long-term, heavy use of glucocorticoids or immunosuppressive drugs within 3 months prior to signing the icf * patients with a history of mental illness who are deemed unfit to participate in the study by the investigator; or a history of suicidal ideation or suicide attempts within the past year or currently; * patients who have used botulinum toxin within 6 months prior to signing the icf * patients with active epilepsy or currently on anti-epileptic drugs * patients with a history of dementia or severe cognitive disorder, or the score of mds-updrs 1.1 during screening is \> 3; poor compliance, inability to accurately keep diary, and/or inability to sign icf due to dementia * patients with severe depression or with severe anxiety during screening; * patients with the following abnormalities during screening, including: abnormal coagulation; abnormal immunological tests, and assessed by the investigator it is not suitable to participate in the trial; hypertensive patients with poorly controlled blood pressure and patients with severe postural hypotension; diabetic patients with poorly controlled blood glucose * patients with surgical contraindications, or with other surgical procedures within 6 months before screening which, in the opinion of the investigator, have an impact on this trial; patients with other neurosurgical contraindications * patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (copd) * presence of one of the following: positive for human immunodeficiency virus (hiv) antibody, treponema pallidum antibody, hepatitis c virus (hcv) antibody and hcv rna; hepatitis b virus (hbv) surface antigen positive and hbv dna copy number \> detection of normal values; tuberculosis is in the active stage; other active infections that the investigator believes may affect patients' participation in the study or affect study outcomes; * patients with alcohol addiction or positive for drug of abuse testing * patients with a history of contraindication or allergy to the drugs used during the study or any of its components, or are allergic to the same drugs or other macrolides, or have allergies; * female of childbearing potential who are not surgically sterilized/premenopausal/unwilling to use medically approved effective contraception with 2 years after administration of investigational drug and lactating women; men who are not surgically sterilized/unwilling to use medically approved effective contraception with 2 years after administration of investigational drug * patients who have received electric shock therapy within 30 days prior to surgery * patients who are participating in other clinical trials, or have been enrolled in other clinical studies and received intervention therapy within 3 months prior to the surgery * patients with poor compliance based on clinical evaluation of the investigator * patients who are being treated with drugs such as apomorphine, or levodopa/carbidopa infusion therapy * patients with severe dyskinesia in both on- and off-drug states

Keywords: parkinson disease dopaminergic progenitor cells