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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029597
Receipt No. R000033817
Scientific Title Revascularization by Peripheral Blood Mononuclear Cell Transplantation
Date of disclosure of the study information 2017/10/17
Last modified on 2017/10/17

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Basic information
Public title Revascularization by Peripheral Blood Mononuclear Cell Transplantation
Acronym Revascularization by Peripheral Blood Mononuclear Cell Transplantation
Scientific Title Revascularization by Peripheral Blood Mononuclear Cell Transplantation
Scientific Title:Acronym Revascularization by Peripheral Blood Mononuclear Cell Transplantation
Region
Japan

Condition
Condition Critical limb ischemia due to peripheral artery disease (critical limb ischemia) and Buerger's disease
Classification by specialty
Medicine in general Cardiology Dermatology
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study is to demonstrate the benefit of peripheral blood mononuclear cell transplantation on critical limb ischemia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of skin perfusion pressure at 6 weeks after initial administration of peripheral blood mononuclear cell transplantation.
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 The concentrated solution of the patien ts' mononuclear cells administered to th e affected limb with ulcer lesions by int ramuscular injection. Repeat again the same treatment after two weeks.
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) Patients with critical limb ischemia caused by peripheral artery disease or Burger's disease.
2) over 20 years old
3) patient who can take a informed con sent
Key exclusion criteria 1) Patients who have severe hypersensitivity or history of side effects to aphaeresis.
2) Patients who have malignant tumor or history of malignancy within the past 3 years.
3) Patients who have experienced acute myocardial infarction, unstable angina pectoris, myocarditis or cerebral infarction within 3 months.
4) Patients with active infection.
5) Patients who are pregnant or might be pregnant.
6) Patients with proliferative diabetic retinopathy (untreated, medium-term and late proliferative retinopathy)
the end of treatment example is excluded.
7) Patients with platelets less than 70,000 platelets in blood test just before apheresies.
8) Patients with less than serum albumin 2 mg/dL.
9) Patients who are judged inappropriate for this trial by their attending physician.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Tsujita
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL 81-96-373-5175
Email tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Fujisue
Organization Kumamoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
TEL 81-96-373-5175
Homepage URL
Email fujisues@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Kumamoto University
Organization
Division
Category of Funding Organization Other
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
2017 Year 10 Month 17 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
2017 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 20 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
2017 Year 10 Month 17 Day
Last modified on
2017 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033817

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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