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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001597
Receipt No. R000001916
Scientific Title Improvement of peripheral blood flow following autologous peripheral mononuclear cells transplantation in patients with peripheral arterial diseases
Date of disclosure of the study information 2008/12/24
Last modified on 2012/04/17

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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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