UMIN-CTR Clinical Trial

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 Kenichi Middle name Last name Tsujita
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Zip code	860-8556
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 Koichiro Middle name Last name Fujisue
Organization	Kumamoto University Hospital
Division name	Department of Cardiovascular Medicine
Zip code	860-8556
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	the Institutional Review Board or Independent Ethics Committee of Kumamoto University Graduate of Medicine
Address	1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
Tel	81-96-373-5657
Email	byi-senshin@jimu.kumamoto-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

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	6
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	Terminated
Date of protocol fixation	2017 Year 07 Month 10 Day
Date of IRB	2017 Year 07 Month 10 Day
Anticipated trial start date	2017 Year 10 Month 20 Day
Last follow-up date	2021 Year 03 Month 31 Day
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	2021 Year 09 Month 13 Day

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