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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01860794
• Date of registration: 14/05/2013
• Prospective Registration: No
• Primary sponsor: Bundang CHA Hospital
• Public title: Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease
• Scientific title: Investigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's Disease
• Date of first enrolment: May 2013
• Target sample size: 15
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT01860794
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Korea, Republic of

Contacts

• Name: Sang Sup Chung, M.D., Ph.D.

• Name: Sang Sup Chung, M.D., Ph.D.
• Affiliation: CHA University

• Name: Sang Sup Chung, M.D., Ph.D.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Primary Parkinsonism

Idiopathic Parkinson Disease

Intervention(s)

Drug: Mesencephalic Neuronal Precursor Cells

Primary Outcome(s)

Presence or absence of cancer foramtion and infection [Time Frame: 5 years]

Secondary Outcome(s)

Dopaminergic drug dose [Time Frame: 5 years]

Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test [Time Frame: 5 years]

Tremor, postural instability, motor dysfunction, gait disturbance [Time Frame: 5 years]

Assessing the extent of recovery with patient's diary [Time Frame: 5 years]

Score of activity of daily living (ADL) scale [Time Frame: 5 years]

Score of Korean mini-mental examination (K-MMSE) [Time Frame: 5 years]

Satisfaction score with patient questionnaire [Time Frame: 5 years]

Motor fluctuation scale scores [Time Frame: 5 years]

Score of Unified Parkinson's Disease Rating Scale (UPDRS) [Time Frame: 5 years]

Detection of positron emission in Putamen using Positron emission tomograph(PET) [Time Frame: 5 years]

Dyskinesia scale scores(CAPSIT-PD) [Time Frame: 5 years]

Secondary ID(s)

PBC09-074

Source(s) of Monetary Support

Please refer to primary and secondary sponsors