Idiopathic Parkinson DiseasePhase 1/2NCT01860794
Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's Disease
A Phase 1/2 study testing Mesencephalic Neuronal Precursor Cells in people with Idiopathic Parkinson Disease and Primary Parkinsonism, run by Bundang CHA Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Parkinson Disease, Primary Parkinsonism
- What is being tested?
- Mesencephalic Neuronal Precursor Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to Apr 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, 463-712
Sang Sup Chung, M.D., Ph.D., 82-31-780-5261, sschung@cha.ac.kr
In Bo Han, M.D., Ph.D., 82-31-780-5688, hanib@cha.ac.kr
About this study
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.
Read the 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.
- Conditions
- Idiopathic Parkinson Disease, Primary Parkinsonism
- Being tested
- Mesencephalic Neuronal Precursor Cells
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesencephalic Neuronal Precursor CellsDrug
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 group | Role | What they receive |
|---|---|---|
| Mesencephalic Neuronal Precursor Cells | Other | Not described Receives: Drug: Mesencephalic Neuronal Precursor Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (11)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startMay 2013
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Sup Chung, Bundang CHA Hospital
- Investigators
- Sang Sup Chung, M.D., Ph.D., Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860794
- Sponsor's protocol ID
- PBC09-074
- Status last verified
- Jul 2020
- First submitted
- 14 May 2013
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01860794
- Acronym / sponsor ID
- PBC09-074
- Conditions
- Idiopathic Parkinson Disease, Primary Parkinsonism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 23 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesencephalic Neuronal Precursor Cells | Other | Drug: Mesencephalic Neuronal Precursor Cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesencephalic Neuronal Precursor CellsAll 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. | Drug | Mesencephalic Neuronal Precursor Cells |
Primary outcome
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
11 secondary outcomes
Score of Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 5 years
Detection of positron emission in Putamen using Positron emission tomograph(PET)
Time frame: 5 years
Dyskinesia scale scores(CAPSIT-PD)
Time frame: 5 years
Pronation-supination test, Hand/Arm movement between two points, finger dexterity, stand-walk-sit-test
Time frame: 5 years
Score of activity of daily living (ADL) scale
Time frame: 5 years
Score of Korean mini-mental examination (K-MMSE)
Time frame: 5 years
Motor fluctuation scale scores
Time frame: 5 years
Satisfaction score with patient questionnaire
Time frame: 5 years
Dopaminergic drug dose
Time frame: 5 years
Tremor, postural instability, motor dysfunction, gait disturbance
Time frame: 5 years
Assessing the extent of recovery with patient's diary
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Sup Chung, M.D., Ph.D. principal investigator
CHA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesencephalic Neuronal Precursor Cells in people with Idiopathic Parkinson Disease and Primary Parkinsonism, run by Bundang CHA Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Sup Chung, M.D., Ph.D. (82-31-780-5261, jmoon@cha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of cancer foramtion and infection (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.