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Investigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's Disease


Phase 1/Phase 2
18 Years
70 Years
Open (Enrolling)
Female
Idiopathic Parkinson Disease, Primary Parkinsonism

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Trial Information

Investigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's Disease


This study is phase I/II clinical trials which is accessible to those involved in the study
and conducted by only Bundang CHA hospital.

The progress of the clinical trails is reported to and evaluated by Data monitoring
committee before the enrolment of next human subject.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Presence or absence of cancer foramtion and infection

Outcome Description:

If not included in the following criteria, the cells are are considered to be safe and tolerable. Cells with grade 3 or more in NCI grading system Cells contaminated with infectious materials Cells with risk of cancer formation

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Sang Sup Chung, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHA Bundang Medical center, CHA university

Authority:

Korea: Institutional Review Board

Study ID:

PBC09-074

NCT ID:

NCT01860794

Start Date:

May 2013

Completion Date:

February 2018

Related Keywords:

  • Idiopathic Parkinson Disease
  • Primary Parkinsonism
  • Parkinson Disease
  • Parkinsonian Disorders

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