UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050104 |
|---|---|
| Receipt number | R000056992 |
| Scientific Title | Observational study one year after transplantation of iPS cell-derived neural precursor/stem cells for spinal cord injury |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2025/07/31 11:21:04 |
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Basic information
Public title
Observational study one year after transplantation of iPS cell-derived neural precursor/stem cells for spinal cord injury
Acronym
Observational study one year after transplantation of iPS-NS/PCs for spinal cord injury
Scientific Title
Observational study one year after transplantation of iPS cell-derived neural precursor/stem cells for spinal cord injury
Scientific Title:Acronym
Observational study one year after transplantation of iPS-NS/PCs for spinal cord injury
Region
| Japan |
Condition
Condition
spinal cord injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Follow up after transplantation of iPS-NS/PC
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Efficacy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Finished follow up of one-year observation from the clinical study "regeneration therapy for spinal cord injury by transplantation of iPS-NS/PC"
2. 18 years old or older
3. Agreement by signature
Key exclusion criteria
1, transplantation of other cells
2, judged as not applicable
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University
Division name
School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokkyo, Japan
TEL
03-3353-1211
okanolab2020sci@gmail.com
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Nakamura |
Organization
Keio University
Division name
School of Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku, Tokkyo, Japan
TEL
03-3353-1211
Homepage URL
okanolab2020sci@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio Universitiy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Keio University school of medicine
Address
35 Shinanomachi, Shinjuku, Tokkyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2023 | Year | 05 | Month | 01 | 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
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2035 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2023 | Year | 01 | Month | 23 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056992
| Research Plan | |
|---|---|
| Registered date | File name |
| 2025/01/27 | B_プロトコル_iPS観察研究20230303.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2025/01/27 | H_CRF.pptx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2025/01/27 | H_CRF.pptx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/56992
