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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01860794
Other study ID # PBC09-074
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2013
Est. completion date April 2022

Study information

Verified date July 2020
Source Bundang CHA Hospital
Contact Sang Sup Chung, M.D., Ph.D.
Phone 82-31-780-5261
Email jmoon@cha.ac.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date April 2022
Est. primary completion date April 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Drug:
Mesencephalic Neuronal Precursor Cells
All the patients are continuously registered for this study. Data monitoring committee inspects the clinical results of first patient and decides whether the treatment for four subjects are appropriate to proceed. 5 subjects of each group are subject to inspection by Data monitoring committee after the end of tracking fifth patients.

Locations

Country Name City State
Korea, Republic of CHA Bundang Medical Center, CHA University Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Presence or absence of cancer foramtion and infection 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
5 years
Secondary Score of Unified Parkinson's Disease Rating Scale (UPDRS) UPDRS, most commonly used, is designed to assess the severity of parkinson's disease, making the quantitative measurement of the extent. Part III of UPDRS corresponds to motor evaluation and is the most reliable for detecting symptomatic progression.
UPDRS improvement ratio(%) = ((the value of UPDRS before surgery - the value of UPDRS after surgery) / (the value of UPDRS before surgery)) X 100
5 years
Secondary Detection of positron emission in Putamen using Positron emission tomograph(PET) In pet analysis, putamen activity is investigated via radioactivity before cell transplantation and 12,24,36,48,60 months after the treatment. 5 years
Secondary Dyskinesia scale scores(CAPSIT-PD) Overall inspection was carried out before transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60 months after the treatment for determining whether the cells have therapeutic effects. 5 years
Secondary Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test Comprehensive clinical assessment for examining the improvements in self reporting and timed testing before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment:Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test. 5 years
Secondary Score of activity of daily living (ADL) scale Comprehensive clinical assessment for examining the improvements in activity of daily living before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. 5 years
Secondary Score of Korean mini-mental examination (K-MMSE) Comprehensive clinical assessment for examining the improvements in mental state before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. 5 years
Secondary Motor fluctuation scale scores Comprehensive clinical assessment for identifying the presence of motor fluctuation symptoms before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. 5 years
Secondary Satisfaction score with patient questionnaire Measure of patient satisfaction before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. 5 years
Secondary Dopaminergic drug dose Measure of dopaminergic drug dose before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. 5 years
Secondary Tremor, postural instability, motor dysfunction, gait disturbance Using video recording, assessment for symptoms such as tremor, postural instability, motor dysfunction and gait disturbance before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. 5 years
Secondary Assessing the extent of recovery with patient's diary Assessing the extent of recovery based on patient's diary before the cell transplantation and 1, 3, 6, 9, 12, 15, 18, 21, 24,30, 36, 42, 48, 54, 60 months after the treatment. 5 years
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