Parkinson's disease
Conditions
Interventions
low-dose group:transnasal injection of hNSC
Middle dose group:transnasal injection of hNSC
High-dose group: transnasal injection of hNSC
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 50-75 years, regardless of gender. 2. Diagnosis consistent with clinically established Parkinson's disease in MDS-PD criteria23. 3. Duration of disease >= 5 years. 4. An OFF state Hoehn and Yahr scale (H&Y) score 3. 5. Stable use of levodopa equivalent daily dose >= 300 mg for at least 1 month prior to enrollment. 6. Patient and/or their legal authorized representative agree to participate in this clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergy or serious adverse reaction to the ingredients of the test preparation, or allergic constitution; 2. Various secondary Parkinsonism (including drugs, cerebrovascular diseases, encephalitis, hydrocephalus, brain tumors, etc.), atypical parkinsonism (multiple system atrophy, progressive suprachional palsy, cortical basal ganglia syndrome, Lewy body disease), and other non-primary Parkinson's diseases (including but not limited to Wilson's disease, Huntington's disease, Fahr disease, etc.); 3. Receiving surgical treatment for Parkinson's disease (including DBS and ablative brain surgery) in the past or during the planned study; 4. Receiving embryonic tissue transplantation for Parkinson's disease in the past or during the planned study; 5. Bilateral nasal diseases, which were judged by the investigators to affect intranasal administration of test preparations or could not be recovered within 1 week after surgery; 6. Complicated with serious cardiovascular and cerebrovascular diseases (history of myocardial infarction within 6 months, cerebrovascular accident within 3 months, NYHA grade III-IV) or major diseases of digestive, respiratory, blood and other systems; 7. Combined with tumor or previous tumor history; 8. Positive results of four tests (hepatitis B surface antigen, HIV antibody, hepatitis C antibody, syphilis antibody); 9. Abnormal liver and kidney function tests (ALT and AST values > 2 times the upper limit of normal, or SCr > 2 times the upper limit of normal); 10. alcoholics or drug abusers or drug addicts; 11. Patients with other serious neurological or psychiatric diseases who are unable or unwilling to cooperate to complete the required examination items, or patients with suicidal tendencies, or patients with dementia (MMSE= 2 times during the prior 6 months due to hypostatic pneumonia. 15. Participated in other clinical researchers within 3 months before enrollment; 16. Other conditions that the researcher considers inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| MDS-UPDRS score;Hoehn-Yahr scores;Scores of non-motor symptom related scales (NMSS, MMSE, MoCA, HAMD, HAMA, FSS, SCOPA-AUT, PDQ-39);levodopa equivalent daily dose;DAT-PET; | — |
Countries
China
Contacts
Public ContactWang Renzhi
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed