Phase
Condition
N/ATreatment
Human Dopaminergic Progenitor Cells
Clinical Study ID
Ages 50-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 50-75 years old, male or female
Able to understand the rationale of the clinical trial and sign informed consentform (ICF)
Diagnosis of Parkinson's Disease in accordance with the MDS clinical diagnosticcriteria 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 inMagnetic 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 positivefor the Acute Levodopa Challenge Test (ALCT)
Acceptable laboratory test results during screening and prior to transplantation
Exclusion
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 wellas other surgical procedures that are judged by the investigator to affect patient'sparticipation 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 brainimaging abnormalities in the striatum or other brain areas leading to asignificantly 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 significanthemorrhagic tendency within 3 months prior to screening, or who cannot temporarilysuspend anti-platelet agents or other anti-coagulant medications for at least 5 daysbefore surgery
Patients with long-term, heavy use of glucocorticoids or immunosuppressive drugswithin 3 months prior to signing the ICF
Patients with a history of mental illness who are deemed unfit to participate in thestudy by the investigator; or a history of suicidal ideation or suicide attemptswithin 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 ofMDS-UPDRS 1.1 during screening is > 3; poor compliance, inability to accurately keepdiary, 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: Abnormalcoagulation; Abnormal immunological tests, and assessed by the investigator it isnot suitable to participate in the trial; Hypertensive patients with poorlycontrolled blood pressure and patients with severe postural hypotension; Diabeticpatients with poorly controlled blood glucose
Patients with surgical contraindications, or with other surgical procedures within 6months before screening which, in the opinion of the investigator, have an impact onthis trial; Patients with other neurosurgical contraindications
Patients with other combined severe systemic diseases, such as pulmonary heartdisease, 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 > detectionof normal values; Tuberculosis is in the active stage; Other active infections thatthe investigator believes may affect Patients' participation in the study or affectstudy 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 thestudy or any of its components, or are allergic to the same drugs or othermacrolides, or have allergies;
Female of childbearing potential who are not surgicallysterilized/premenopausal/unwilling to use medically approved effective contraceptionwith 2 years after administration of investigational drug and lactating women; menwho are not surgically sterilized/unwilling to use medically approved effectivecontraception 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 inother clinical studies and received intervention therapy within 3 months prior tothe surgery
Patients with poor compliance based on clinical evaluation of the investigator
Patients who are being treated with drugs such as apomorphine, or levodopa/carbidopainfusion therapy
Patients with severe dyskinesia in both on- and off-drug states
Study Design
Study Description
Connect with a study center
Beijing Hospital
Beijing, Beijing 100730
ChinaActive - Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei 430071
ChinaSite Not Available
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