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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046192
Receipt No. R000052717
Scientific Title Long term outcomes survey of bone marrow-derived mononuclear cells implantation for chronic limb-threatening ischemia
Date of disclosure of the study information 2021/12/01
Last modified on 2021/11/26

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Basic information
Public title Long term outcomes survey of bone marrow-derived mononuclear cells implantation for chronic limb-threatening ischemia
Acronym Long term outcomes survey of bone marrow-derived mononuclear cells implantation for chronic limb-threatening ischemia
Scientific Title Long term outcomes survey of bone marrow-derived mononuclear cells implantation for chronic limb-threatening ischemia
Scientific Title:Acronym Long term outcomes survey of bone marrow-derived mononuclear cells implantation for chronic limb-threatening ischemia
Region
Japan

Condition
Condition chronic limb threatening ischemia
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of long term outcomes for bone marrow-derived mononuclear cells implantation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Death
Amputation
Key secondary outcomes

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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who were performed the bone marrow-derived mononuclear cells implantation from 2010 January to 2019 December.
Key exclusion criteria none
Target sample size 88

Research contact person
Name of lead principal investigator
1st name Satoaki
Middle name
Last name Matoba
Organization Kyoto prefectural university of medicine
Division name Department of Cardiovascular Medicine
Zip code 6028566
Address 465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL 075-251-5511
Email yanishi@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Yanishi
Organization Kyoto prefectural university of medicine
Division name Department of Cardiovascular Medicine
Zip code 6028566
Address 465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL 075-251-5511
Homepage URL
Email yanishi@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural university of medicine
Institute
Department

Funding Source
Organization Kyoto prefectural university of medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto prefectural university of medicine
Address 465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
Tel 075-251-5511
Email yanishi@koto.kpu-m.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
2021 Year 12 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 12 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2021 Year 11 Month 26 Day
Last modified on
2021 Year 11 Month 26 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052717

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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