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

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

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Parkinson Disease; Primary Parkinsonism
• Intervention / Treatment: Drug: Mesencephalic Neuronal Precursor Cells

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sang Sup Chung, M.D., Ph.D.; Phone Number: 82-31-780-5261; Email: jmoon@cha.ac.kr
• Study Contact Backup: Name: Joo pyung Kim, M.D., Ph.D.; Phone Number: 82-31-780-5000; Email: jpkim@cha.ac.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
      • Recruiting
      • CHA Bundang Medical Center, CHA University
      • Contact: Sang Sup Chung, M.D., Ph.D.; Phone Number: 82-31-780-5261; Email: sschung@cha.ac.kr
      • Contact: In Bo Han, M.D., Ph.D.; Phone Number: 82-31-780-5688; Email: hanib@cha.ac.kr
      • Principal Investigator: Sang Sup Chung, M.D., Ph.D.
      • Sub-Investigator: In Bo Han, M.D., Ph.D.
      • Sub-Investigator: Joo Pyung Kim, M.D., Ph.D.
      • Sub-Investigator: Yong Soo Choi, Ph.D.
      • Sub-Investigator: Hyun Sook Kim, M.D., Ph.D.
      • Sub-Investigator: Won Chan Kim, M.D., Ph.D.
      • Sub-Investigator: Sang Heum Kim, M.D., Ph.D.
      • Sub-Investigator: Eun Hye Yoo, M.D., Ph.D.
      • Sub-Investigator: Su Jin Jang, M.D., Ph.D.
      • Sub-Investigator: Jisook Moon, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mesencephalic Neuronal Precursor Cells	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bundang CHA Hospital
• Investigators: Principal Investigator: Sang Sup Chung, M.D., Ph.D., CHA University

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 21, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Parkinsonian Disorders
• Other Study ID Numbers: PBC09-074