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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01860794
Recruitment Status : Recruiting
First Posted : May 23, 2013
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Sang Sup Chung, Bundang CHA Hospital

Tracking Information
First Submitted Date  ICMJE May 14, 2013
First Posted Date  ICMJE May 23, 2013
Last Update Posted Date July 10, 2020
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
Presence or absence of cancer foramtion and infection [ Time Frame: 5 years ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2013)
  • Score of Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 5 years ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease
Official Title  ICMJE Investigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Idiopathic Parkinson Disease
  • Primary Parkinsonism
Intervention  ICMJE 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.
Study Arms  ICMJE Mesencephalic Neuronal Precursor Cells
Intervention: Drug: Mesencephalic Neuronal Precursor Cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sang Sup Chung, M.D., Ph.D. 82-31-780-5261 jmoon@cha.ac.kr
Contact: Joo pyung Kim, M.D., Ph.D. 82-31-780-5000 jpkim@cha.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01860794
Other Study ID Numbers  ICMJE PBC09-074
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang Sup Chung, Bundang CHA Hospital
Study Sponsor  ICMJE Bundang CHA Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sang Sup Chung, M.D., Ph.D. CHA University
PRS Account Bundang CHA Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP