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

Primary Purpose

Idiopathic Parkinson Disease, Primary Parkinsonism

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mesencephalic Neuronal Precursor Cells
Sponsored by
Bundang CHA Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CHA Bundang Medical Center, CHA UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Mesencephalic Neuronal Precursor Cells

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 14, 2013
Last Updated
July 9, 2020
Sponsor
Bundang CHA Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01860794
Brief Title
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bundang CHA Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson Disease, Primary Parkinsonism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesencephalic Neuronal Precursor Cells
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Mesencephalic Neuronal Precursor Cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence or absence of cancer foramtion and infection
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Score of Unified Parkinson's Disease Rating Scale (UPDRS)
Description
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
Time Frame
5 years
Title
Detection of positron emission in Putamen using Positron emission tomograph(PET)
Description
In pet analysis, putamen activity is investigated via radioactivity before cell transplantation and 12,24,36,48,60 months after the treatment.
Time Frame
5 years
Title
Dyskinesia scale scores(CAPSIT-PD)
Description
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.
Time Frame
5 years
Title
Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test
Description
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.
Time Frame
5 years
Title
Score of activity of daily living (ADL) scale
Description
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.
Time Frame
5 years
Title
Score of Korean mini-mental examination (K-MMSE)
Description
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.
Time Frame
5 years
Title
Motor fluctuation scale scores
Description
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.
Time Frame
5 years
Title
Satisfaction score with patient questionnaire
Description
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.
Time Frame
5 years
Title
Dopaminergic drug dose
Description
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.
Time Frame
5 years
Title
Tremor, postural instability, motor dysfunction, gait disturbance
Description
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.
Time Frame
5 years
Title
Assessing the extent of recovery with patient's diary
Description
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.
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female patients with idiopathic or primary Parkinson's disease Hoehn and Yare (HY) stage III or IV more than 33% improvement Part III UPDRS score after one injection of levodopa in the morning Patients aged less than 70 Great decrease of dopamine uptake in putamen, particularly posterior part, in Positron emission tomograph(PET) before surgery Exclusion Criteria: Atypical or secondary parkinsonism Medical history of severe depression with Beck Depression Inventory(BDI) scores greater than 30 Psychological disorders (illusion, delusion, schizophrenia) Dementia with K-MMSE(Korean mini-mental state examination) scores less than 24 Epilepsy Medial history of brain surgery Medical history of other brain diseases Hemorrhagic tendency Severe internal diseases such as poor general condition, hypertension, chronic respiratory disease, ischemic heart disease, cancer Experience of participating in clinical trial within 30 days Female patients who have the chances of getting pregnant during clinical trial and do not use the approved birth controls Pregnant or lactating women Patients who are not considered to be eligible to participate in clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Sup Chung, M.D., Ph.D.
Phone
82-31-780-5261
Email
jmoon@cha.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Joo pyung Kim, M.D., Ph.D.
Phone
82-31-780-5000
Email
jpkim@cha.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Sup Chung, M.D., Ph.D.
Organizational Affiliation
CHA University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA Bundang Medical Center, CHA University
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Sup Chung, M.D., Ph.D.
Phone
82-31-780-5261
Email
sschung@cha.ac.kr
First Name & Middle Initial & Last Name & Degree
In Bo Han, M.D., Ph.D.
Phone
82-31-780-5688
Email
hanib@cha.ac.kr
First Name & Middle Initial & Last Name & Degree
Sang Sup Chung, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
In Bo Han, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Joo Pyung Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Yong Soo Choi, Ph.D.
First Name & Middle Initial & Last Name & Degree
Hyun Sook Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Won Chan Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Sang Heum Kim, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Eun Hye Yoo, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Su Jin Jang, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
Jisook Moon, Ph.D.

12. IPD Sharing Statement

Learn more about this trial

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

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