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

Idiopathic Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01860794
• Other study ID #: PBC09-074
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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

Related Conditions & MeSH terms

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

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