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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010799
Receipt No. R000012642
Scientific Title Hematopoietic stem cell transplantation for patients with ischemic limbs
Date of disclosure of the study information 2013/05/24
Last modified on 2016/03/02

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Basic information
Public title Hematopoietic stem cell transplantation for patients with ischemic limbs
Acronym Therapeutic angiogenesis
Scientific Title Hematopoietic stem cell transplantation for patients with ischemic limbs
Scientific Title:Acronym Therapeutic angiogenesis
Region
Japan

Condition
Condition Patients with intractable ulcers caused by collagen diseases
Classification by specialty
Medicine in general Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness and tolerability of angiogenesis by autologous transplantation of bone marrow-derived cells in patients with ischemic limbs
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of gangrene and reduction of ulcer size
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
Maneuver
Interventions/Control_1 Under general anesthesia, about 500-700 ml of bone marrow cells are collected from the ilium and mononuclear cells are separated on a centrifugal blood-cell separator. After separation, cells are concentrated by centrifugation. The cells are immediately implanted by intramuscular injection into an ischemic limb. In practice, we injected 0.5 ml of cells with
a 20-gauge needle 50 times at even intervals into an ischemic limb.
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
65 years-old >
Gender Male and Female
Key inclusion criteria Patients with collagen diseases are eligible
for the study if they have nonhealing ischemic ulcer caused by vasculopathy and their ulcers are resistant to conventional therapy.
Key exclusion criteria We exclude patients with severe
involvement of the lung and heart.
We also exclude patients with active retinopathy due to diabetes mellitus, with evidence of malignant disorder during the past 5 years, or with history of cerebral stroke during the past a year. Patients with a history of alcohol and/or drug dependency during the past 3 months are also excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Ishigatsubo
Organization Yokohama City University Graduate School of Medicine
Division name Department of Internal Medicine and Clinical Immunology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2630
Email ishigats@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryusuke Yoshimi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Internal Medicine and Clinical Immunology
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2630
Homepage URL
Email yoshiryu@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Internal Medicine and Clinical Immunology
Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University
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
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
2013 Year 05 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 Open public recruiting
Date of protocol fixation
2013 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 24 Day
Last modified on
2016 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012642

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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