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 2024/01/26 13:13:25

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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

Email

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


Email

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

Email

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

Enrolling by invitation

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

2024 Year 01 Month 26 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

Research case data specifications
Registered date File name

Research case data
Registered date File name