UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000016065