UMIN-CTR Clinical Trial

Basic information
Public title	Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Acronym	Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Scientific Title	Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Scientific Title:Acronym	Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Region	Japan

Condition
Condition	Peripheral Arterial Disease (Fontaine stages three and four)
Classification by specialty	Cardiology Vascular surgery Orthopedics Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We have reported that mesenhymal stem cells (MSC)could differentiate into vascular endothelial cells and produce vascular endothelial grows factor.The aim of this study is to investigate the efficacy and safety of culture expanded MSC for the treatments of peripheral artery disease. The MSC is derived from small amount(about 20ml) of patient's bone marrow cells and will be injected into the same patient's limb
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	ABI(Ankle Brechial Pressure Index): 7days, 1,6 and 12 months post transplantation. Angiography : 12 months post transplantation.
Key secondary outcomes	Walking time without pain using tredmil: 1, 6 and 12 months post transplantation

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	Bone marrow of about 20ml is taken from the patient. The bone marrow is transferred to National Institute of Advanced Industrial Science and Technology (AIST) at Amagasaki city and cultured to expand the mesenchymal stem cell. The stem cell is transferred back to the hospital. Half ml of mesenchymal stem cells (2.5 x 106 cells/ml) is injected into ischemic area of lower extremity. The injection sites per extremity are about 40. When both extremities show ischemic change, more severe extremity is selected. If some clinical effect after the injection appear but not satisfactory, several repeated injection will be done, furthermore, if injection into other extremity is thought to be effective, another injection is done for this extremity. Total duration of the injection is within a half year after the first injection of the MSCs.
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) Peripheral Artery Disease: PAD (2) Fontaine stages III and IV (ABI less than 0.6) (3) The patient showing contraindications of angioplasty and bypass surgery due to spread areas of stricture or the stricture in small peripheral artery. Patients already treated with such angioplasty and bypass surgery, but showing the symptoms corresponding to above category (2). (4) The patients by whom written consent is got from himself/herself by aged 20 and over (at the time of consent acquisition).
Key exclusion criteria	(1) The patient of hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, and adult T-cell leukemia (2) The hypersensitivity to a cow or pig origin protein, the patient that has the past of side effects (3) The patient showing severe cardiac failure evidenced by cardiac echo examination. (4) Malignant diseases. (5) High-risk retinopathy (6) Serious problems of liver and renal function (7) Interstitial pneumonia. (8) Blood diseases such as anemia and leykocytosis. (9) A pregnant woman, a nursing mother, the patient that may have become pregnant, the female patient who is planning pregnancy by the end of this treatment term. (10) In addition, the patient whom the principal investigator or the researcher judged to be unsuitable based on the medical rationale
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hajime Ohgushi
Organization	Ookuma Hospital
Division name	Department of Orthopedics
Zip code
Address	2-17-13 Kuise-honmachi, Amagasaki City, Hyogo 660-0814, JAPAN
TEL	06+64811667
Email

Public contact
Name of contact person	1st name Middle name Last name Hiroaki Narita
Organization	Rogenkai Welfare Group
Division name	Headquarters
Zip code
Address	4-27-6 Higashi- sonoda -cho, Amagasaki, City, Hyogo 661-0953, JAPAN
TEL	06+64158590
Homepage URL
Email	narita@ookuma.or.jp

Sponsor
Institute	Rogenkai Welfare Group
Institute
Department

Funding Source
Organization	National Institute of Advanced Industrial Science and Technology (AIST)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Institute of Advanced Industrial Science and Technology (AIST)
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 12 Month 01 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	2013 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date	2014 Year 01 Month 21 Day
Last follow-up date	2016 Year 11 Month 12 Day
Date of closure to data entry	2016 Year 11 Month 12 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 02 Month 03 Day
Last modified on	2017 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011647

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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