UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048476 |
|---|---|
| Receipt number | R000055244 |
| Scientific Title | Long-term follow up study after transplantation of human iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease |
| Date of disclosure of the study information | 2022/07/26 |
| Last modified on | 2022/07/27 20:41:42 |
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Basic information
Public title
Long-term follow up study after transplantation of human iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease
Acronym
Long-term follow up study after transplantation of human iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease
Scientific Title
Long-term follow up study after transplantation of human iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease
Scientific Title:Acronym
Long-term follow up study after transplantation of human iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of transplantation of human induced pluripotent stem cell-derived dopaminergic progenitors into the corpus striatum in patients with Parkinson's disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Observation of transplanted iPSC-derived dopaminergic progenitors
[18F]-FDOPA PET [With Carbidopa (Lodosyn)], [123I]-ioflupane SPECT and 7 tesla MRI
Key secondary outcomes
Evaluation of motor and non-motor symptoms
Evaluation of clinical and laboratory examinations
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study participants enrolled in the preceding clinical trial, transplanted human iPS cell-derived dopaminergic progenitors and completed the observation period of the clinical trial.
Key exclusion criteria
1. Serious communication problems (to ensure safety during examinations).
2. Bad general condition (such as abnormal vital signs).
3. Serious infectious and other complications.
4. Women who are pregnant or may be pregnant. Women who are breastfeeding.
5. Participants who are judged to be inappropriate to be involved by the investigators.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Nobukatsu |
| Middle name | |
| Last name | Sawamoto |
Organization
Kyoto University Hospital
Division name
Department of Neurology
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507
TEL
075-751-3771
neuroofc@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobukatsu |
| Middle name | |
| Last name | Sawamoto |
Organization
Kyoto University Hospital
Division name
Department of Neurology
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto 606-8507
TEL
075-751-3771
Homepage URL
neuroofc@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After fiscal year 2031, we plan to extend this observational study. This study will continue to import pharmaceutical [Carbidopa (Lodosyn)].
Management information
Registered date
| 2022 | Year | 07 | Month | 26 | Day |
Last modified on
| 2022 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055244
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
