Clinical trial NCT01860794: Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Idiopathic Parkinson Disease
Primary Parkinsonism
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Presence or absence of cancer foramtion and infection
timeFrame: 5 years
Secondary outcomes:
measure: Score of Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 5 years
measure: Detection of positron emission in Putamen using Positron emission tomograph(PET)
timeFrame: 5 years
measure: Dyskinesia scale scores(CAPSIT-PD)
timeFrame: 5 years
measure: Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test
timeFrame: 5 years
measure: Score of activity of daily living (ADL) scale
timeFrame: 5 years
measure: Score of Korean mini-mental examination (K-MMSE)
timeFrame: 5 years
measure: Motor fluctuation scale scores
timeFrame: 5 years
measure: Satisfaction score with patient questionnaire
timeFrame: 5 years
measure: Dopaminergic drug dose
timeFrame: 5 years
measure: Tremor, postural instability, motor dysfunction, gait disturbance
timeFrame: 5 years
measure: Assessing the extent of recovery with patient's diary
timeFrame: 5 years
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: Sang Sup Chung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: