Parkinson’s disease
Conditions
Interventions
Sponsors
Shanghai tongji hospital
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 30 to 65 years male and female; 2. The clinical diagnosis is in line with the clinical diagnosis of PD patients in the diagnostic criteria of Parkinson's disease formulated by the international dyskinesia Association (MDS) in 2015; 3. Disease course >=5 years, onset age =300mg/day) of levodopa for at least 1 month; 7. Before enrollment, the following requirements need be met: ALT, AST<=2 times normal upper limit, SCr<=1.5 times normal upper limit; 8. Female patients must meet the following condition: (1) Menopause (defined as at least 1 year without menstruation); (2) Surgical sterilization; (3) If have fertility, must meet: 1) Pregnancy test performed must be negative within 7 days prior to enrollment; 2) Agree to use appropriate contraception (including at least one method) throughout the trial period; 3) Do not breastfeed; 9. Male patients must agree to use appropriate contraception (including at least one method); 10. The patient and/or his/her guardian have agreed to participate in the clinical trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known or suspected patients who are allergic to or have severe adverse reaction to the ingredients of the preparation, or allergy; 2. Parkinson's syndrome and Parkinson's superposition (patients with clear damage in basal ganglia region and not belong to the idiopathic Parkinson's disease confirmed by CT or MRI within 2 years) caused by drugs (such as: metoclopramide, flunarizine), metabolic diseases (Wilson's disease), encephalitis and central nervous system degenerative diseases (such as youth Huntington disease, progressive cores palsy, multiple system atrophy) or basal ganglia diseases (such as Fahr disease or syndrome, etc.); 3. Patients who have had surgery or plan to have surgery during the experiment for treatment to Parkinson's disease; 4. Patients who have received deep brain stimulation or embryonic tissue transplantation; 5. Patients with bilateral nasal cavity disease or judged are unsuitable by the researchers; 6. Patients with the following cardiovascular and cerebrovascular conditions: (1) Heart disease occurred within 6 months, including congestive heart failure unstable angina pectoris (angina pectoris at rest), new angina pectoris (3 months before enrollment) or myocardial infarction these are greater severity than grade II-IV of the New York heart association; (2) Ventricular arrhythmia that need to receive antiarrhythmic drugs; QTc > 470 ms; hypertension that is not well controlled (systolic >150mmHg or diastolic >100mmHg); (3) Thrombotic or embolic venous or arterial events occurred within 6 months before the enrollment, such as cerebrovascular accidents, including transient ischemic attack, stroke, arterial thrombosis, deep venous thrombosis and pulmonary embolism; 7. Patents with mental abnormality; 8. Patients who have autoimmune diseases, immunodeficiency diseases or a history of organ transplantation; 9. Patients infected with HIV, syphilis, HCV or HBV, or have severe infections requiring systemic treatment with antibiotics; 10. Patients who are receiving active treatment for CNS disorders (e.g., sedatives, sleeping pills, antidepressants, anti-anxiety medications), unless the drug dose has been stable for at least 28 days prior to enrollment and may remain stable for the duration of the study; 11. Patients with epilepsy or have a history of epilepsy; 12. Suffering malignancy or during anti-cancer treatment period; 13. Patients with liver dysfunction or kidney dysfunction; 14. Patients who drink heavy, or prone to drug abuse within 5 years; 15. Patients who had used stem cell therapy or participated in stem cell clinical investigation; 16. Patients with any diseases unstable or might compromise patient safety and compliance with the study; 17. Attended other intervention clinical trial within 3 months or during the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;MDS-UPDRS-IV;Evaluation of non-motor symptoms in Parkinson's disease, Mental State Examination; Cognitive assessment; Depression; anxious;; | — |
Secondary
| Measure | Time frame |
|---|---|
| MDS-UPDRS;Hoehn-Yahr;DAT-PET; | — |
Countries
China
Contacts
Public ContactJin Lingjing
Shanghai Tongji Hospital
Outcome results
None listed