Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of clinical trials is to evaluate safety and tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells as a treatment for Patients with Parkinson's disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bundang CHA Hospital
• Treatments: Dopamine

Criteria

Inclusion Criteria:

1. Female patients with idiopathic or primary Parkinson's disease

2. Hoehn and Yare (HY) stage III or IV

3. more than 33% improvement Part III UPDRS score after one injection of levodopa in the morning

4. Patients aged less than 70

5. Great decrease of dopamine uptake in putamen, particularly posterior part, in Positron emission tomograph(PET) before surgery

Exclusion Criteria:

1. Atypical or secondary parkinsonism

2. Medical history of severe depression with Beck Depression Inventory(BDI) scores greater than 30

3. Psychological disorders (illusion, delusion, schizophrenia)

4. Dementia with K-MMSE(Korean mini-mental state examination) scores less than 24

5. Epilepsy

6. Medial history of brain surgery

7. Medical history of other brain diseases

8. Hemorrhagic tendency

9. Severe internal diseases such as poor general condition, hypertension, chronic respiratory disease, ischemic heart disease, cancer

10. Experience of participating in clinical trial within 30 days

11. Female patients who have the chances of getting pregnant during clinical trial and do not use the approved birth controls

12. Pregnant or lactating women

13. Patients who are not considered to be eligible to participate in clinical trial