Parkinson's disease
Conditions
Interventions
cell treatment:human amniotic epithelial stem cells stereotactic transplantation
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 30-70 years with primary Parkinson's disease have a history of more than 5 years, no limit for men and women; 2. Hoehn and Yahr of Parkinson's disease were classified into 2-4 grades (UPDRS score of "close period" was between 38-70; UPDRS score of "close period" before operation was stable, i.e. (high-low value) / high value <= 10%); 3. Patients with stable application of anti Parkinson drugs for more than 3 months; 4. Levodopa was used to treat patients who had been effective; 5. Patients with stable condition, good control of complications, no contraindications of anesthesia, no contraindications of directional operation and other conditions interfering with clinical evaluation; 6. No abnormal patients were found in the head MRI; 7. The patient can be taken care of by someone. The caregiver can provide information about the patient before and after transplantation, and can provide assistance to the researcher if necessary.
Exclusion criteria
Exclusion criteria: 1. Patients with atypical Parkinson's disease, such as Parkinson's syndrome and secondary Parkinson's disease; 2. Parkinson's disease patients with tremor only; 3. Patients who have serious motor disorders and are unable to complete routine motor tasks; 4. Patients with severe neurological deficit caused by other diseases; 5. Patients with severe mental symptoms or dementia; 6. The patient is unwilling to cooperate or unable to complete the self-evaluation, and cannot complete the evaluation with the help of the doctor; 7. Patients with surgical history of striatum or extrapyramidal system, including deep brain stimulation (DBS); 8. Patients who are being treated with apomorphine; 9. Patients with abnormal coagulation or undergoing anticoagulant therapy; 10. Women of childbearing age who do not take effective contraceptive measures; 11. Pregnant or lactating women; 12. Patients who have participated in clinical research of other drugs or medical devices within 3 months; 13. 6 months later, the patients were treated with botulinum toxin, phenol, baclofen or interventional therapy for dystonia or spasm; 14. Patients with epilepsy history or prophylactic use of antiepileptic drugs; 15. Contraindications to general anesthesia or stereotactic surgery, such as sleep apnea, chronic obstructive pulmonary disease; 16. Other situations judged by the researcher that may bring harm to the subjects; 17. Patients with alcohol or drug abuse; 18. Patients who have used diazepam drugs within 3 months; 19. Patients with severe cognitive disorder, depression or behavior disorder were defined as less than 26 points on MMSE and more than 35 points on HAMD; 20. Patients with active diseases or tumors indicated by chest CT; 21. Patients who are suffering from or have suffered from tumors other than basal cell tumors of the skin and carcinoma in situ of the cervix; 22. The patients with HIV and syphilis could not be excluded by the detection of HIV, HBV, HCV and syphilis before operation; 23. For the patients with abnormal liver and kidney function, the basic definition of normal liver and kidney function is that alt, AST are 2.5 times less than the upper limit of normal, bun and Cr are less than the upper limit of normal. 24. Other conditions that the researchers think are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| UPDRS-III;Hoehn-Yahr scores;PDQ-39 scores; | — |
Countries
China
Contacts
Public ContactWu Jing-Wen
Shanghai East Hospital
Outcome results
None listed