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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Bundang CHA Hospital |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04202757 -
Intravenous Plasma Treatment for Parkinson's Disease
|
Early Phase 1 | |
Not yet recruiting |
NCT05103618 -
Effect of Meditation and Controls and Subjects With Parkinson's Disease on Brain Activity Measured by fMRI With FDOPA
|
Phase 2 | |
Completed |
NCT03700684 -
Voice Treatment for Parkinson's Disease
|
N/A | |
Completed |
NCT05027620 -
Feasibility of Motor-cognitive Home Training for Parkinson's Disease Using eHealth Technology
|
N/A | |
Completed |
NCT03652363 -
GDNF in ideopathicParkinsons Disease
|
Phase 2 | |
Recruiting |
NCT02960464 -
tDCS for Treatment of Depression in Parkinson's Disease
|
N/A | |
Completed |
NCT05699161 -
Adipose-derived Stromal Vascular Fraction Cells to Treat Parkinson
|
Phase 1/Phase 2 | |
Completed |
NCT03944785 -
Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)
|
||
Completed |
NCT01227265 -
Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)
|
Phase 3 | |
Terminated |
NCT01215227 -
An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)
|
Phase 3 | |
Withdrawn |
NCT05832775 -
Study to Assess the Safety of MRx0029 or MRx0005 Compared to Placebo, in People With Parkinson's
|
Phase 1 | |
Active, not recruiting |
NCT02780895 -
Parkinsonian Brain Repair Using Human Stem Cells
|
Phase 1 | |
Completed |
NCT02373072 -
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's Disease
|
Phase 1 | |
Terminated |
NCT02393027 -
Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999
|
Early Phase 1 | |
Completed |
NCT02445651 -
Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
|
N/A | |
Completed |
NCT00437125 -
Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease
|
Phase 4 | |
Completed |
NCT02723396 -
Sleep, Awake & Move - Part I
|
||
Completed |
NCT00599339 -
Transdermal Rotigotine User Surveillance Study
|
||
Suspended |
NCT05471609 -
Sustained Release Oral Formulation for Treatment of Parkinson's Disease
|
Early Phase 1 | |
Completed |
NCT00160576 -
Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias
|
Phase 2 |