UMIN-CTR Clinical Trial

Basic information
Public title	Improvement of peripheral blood flow following autologous peripheral mononuclear cells transplantation in patients with peripheral arterial diseases
Acronym	Autologous peripheral mononuclear cells transplantation for peripheral arterial diseases
Scientific Title	Improvement of peripheral blood flow following autologous peripheral mononuclear cells transplantation in patients with peripheral arterial diseases
Scientific Title:Acronym	Autologous peripheral mononuclear cells transplantation for peripheral arterial diseases
Region	Japan

Condition
Condition	peripheral arterial diseases
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect on blood flow following intramuscular administration of peripheral mononuclear cells collected by blood separator in patients with peripheral arterial diseases
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Subjective ischemic symptoms
Key secondary outcomes	Improvement of arterial blood flow Neovascularization Time to amputation

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	Medicine
Interventions/Control_1	intramuscular administration of peripheral mononuclear cells collected by blood separator
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with arteriosclerosis obliterans diagnosed as Fontaine's classification III or IV, or patients with Buerger's disease Patients who were disclosed their arterial disease and agreed with enrollment into the study by document
Key exclusion criteria	Patients intolerable for extracorporeal circulation Congestive heart failure (ejection fraction <50%) Renal failure (serum creatinine < 1.6 mg/dL) Women on (possible) pregnancy or lactation Patients judged inadequate by doctor in charge of the patient or the study
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ippei Sakamaki
Organization	National Hospital Organization Awara Hospital
Division name	Department of Internal Medicine
Zip code
Address	238-1 Kitagata, Awara, Fukui 910-4272, Japan
TEL	0776-79-1211
Email

Public contact
Name of contact person	1st name Middle name Last name Mitsuaki Tanaka
Organization	National Hospital Organization Awara Hospital
Division name	Department of Pharmacy
Zip code
Address	238-1 Kitagata, Awara, Fukui 910-4272, Japan
TEL	0776-79-1211
Homepage URL	http://www.hosp.go.jp/~awara/kenkyu.html
Email	nhoawara-secretary@umin.ac.jp

Sponsor
Institute	National Hospital Organization Awara Hospital
Institute
Department

Funding Source
Organization	National Hospital Organization Awara Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2008 Year 12 Month 24 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	2005 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date	2005 Year 08 Month 01 Day
Last follow-up date	2009 Year 06 Month 01 Day
Date of closure to data entry	2009 Year 07 Month 01 Day
Date trial data considered complete	2009 Year 07 Month 01 Day
Date analysis concluded	2009 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2008 Year 12 Month 24 Day
Last modified on	2012 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001916

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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