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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013820
Receipt No. R000016065
Scientific Title Autologous mesenchymal cell implantation in patients with peripheral artery disease (Arteriosclerosis obliterans, Buerger's disease, collagen disease)
Date of disclosure of the study information 2014/05/01
Last modified on 2019/05/01

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Basic information
Public title Autologous mesenchymal cell implantation in patients with peripheral artery disease (Arteriosclerosis obliterans, Buerger's disease, collagen disease)
Acronym Autologous mesenchymal cell implantation in patients with peripheral artery disease
Scientific Title Autologous mesenchymal cell implantation in patients with peripheral artery disease (Arteriosclerosis obliterans, Buerger's disease, collagen disease)
Scientific Title:Acronym Autologous mesenchymal cell implantation in patients with peripheral artery disease
Region
Japan

Condition
Condition Peripheral artery disease (arteriosclerosis obliterans, Buerger's disease, collagen disease)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the efficacy to improve limb blood flow and safety of autologous mesenchymal cell implantation in patients with peripheral artery disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Safety
a) Adverse event, side effect
b) Laboratory data

2) Efficacy
Primary outcomes (6 months after implantation)
Improvement of symptom or physical examination according to Fontaine classification at baseline
a) Fontaine IIb: >20% improvement of initial claudication distance or absolute claudication distance
b) Fontaine III: >2cm improvement of visual analogue scale
c) Fontaine IV: >25% reduction of ulcer size in patients with ulcer or free of major amputation in patients with gangrene
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Autologous mesenchymal cell implantation
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) written informed consent
2) >20 years of age
3) rest pain, ulcer or gangrene accompanying by stenosis or occlusion of arteries either superficial femoral artery, popliteal artery or below the knee artery
4) not applicable for endovascular therapy or bypass surgery
Key exclusion criteria 1) having malignancy
2) prior myocardial infarction, unstable angina, myocarditis, cerebrovascular infarction within 2 months
3) activating inflammation
4) possible pregnancy
5) activating proliferative retinopathy
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Suzuki
Organization Showa University Fujigaoka Hospital
Division name Deartment of Invernal Medicine, Division of Cardiology
Zip code 227-8501
Address 1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
TEL 0459711151
Email hrsuzuki@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Suzuki
Organization Showa University Fujigaoka Hospital
Division name Deartment of Invernal Medicine, Division of Cardiology
Zip code Hiroshi
Address 1-30 Fujigaoka, Aoba-ku, Yokohama 227-8501, Japan
TEL 045-971-1151
Homepage URL http://www.f-circ.com/
Email hrsuzuki@med.showa-u.ac.jp

Sponsor
Institute Showa University Fujigaoka Hospital
Institute
Department

Funding Source
Organization Showa University Fujigaoka Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Center for Child Health and Development
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University Fujigaoka Hospital
Address 1-30 Fujigaoka, Aoba-ku, Yokohama, Kanagawa
Tel 045-971-1151
Email hrsuzuki@med.showa-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 昭和大学藤が丘病院
Showa University Fujigaoka Hospital

独立行政法人国立成育医療研究センター
National Center for Child Health and Development

Other administrative information
Date of disclosure of the study information
2014 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 Completed
Date of protocol fixation
2013 Year 11 Month 25 Day
Date of IRB
2013 Year 11 Month 25 Day
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 04 Month 27 Day
Last modified on
2019 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016065

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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