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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Bundang CHA Hospital
Sponsor:
Information provided by (Responsible Party):
Sang Sup Chung, Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT01860794
First received: May 14, 2013
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Idiopathic Parkinson Disease
Primary Parkinsonism
Drug: Mesencephalic Neuronal Precursor Cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bundang CHA Hospital:

Primary Outcome Measures:
  • Presence or absence of cancer foramtion and infection [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 15
Study Start Date: May 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860794

Contacts
Contact: Sang Sup Chung, M.D., Ph.D. 82-31-780-5261 sschung@cha.ac.kr
Contact: In Bo Han, M.D., Ph.D. 82-31-780-5688 hanib@cha.ac.kr

Locations
Korea, Republic of
CHA Bundang Medical Center, CHA University Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Contact: Sang Sup Chung, M.D., Ph.D.    82-31-780-5261    sschung@cha.ac.kr   
Contact: In Bo Han, M.D., Ph.D.    82-31-780-5688    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.         
Sponsors and Collaborators
Bundang CHA Hospital
Investigators
Principal Investigator: Sang Sup Chung, M.D., Ph.D. CHA University
  More Information

No publications provided

Responsible Party: Sang Sup Chung, Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT01860794     History of Changes
Other Study ID Numbers: PBC09-074
Study First Received: May 14, 2013
Last Updated: May 21, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dopamine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 22, 2014