UMIN-CTR Clinical Trial

Basic information
Public title	Therapeutic angiogenesis for peripheral artery diseases by combination of adrenomedullin and peripheral mononuclear cell transplantation
Acronym	Therapeutic angiogenseis by combination of adrenomedullin and cell transplantation
Scientific Title	Therapeutic angiogenesis for peripheral artery diseases by combination of adrenomedullin and peripheral mononuclear cell transplantation
Scientific Title:Acronym	Therapeutic angiogenseis by combination of adrenomedullin and cell transplantation
Region	Japan

Condition
Condition	peripheral artery disease
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of therapeutic angiogenesis for peripheral artery diseases by combination of peripheral mononuclear cell transplantation and adrenomedullin administration.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse events
Key secondary outcomes	Improvement of pain, skin necrosis, and walking distance

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	Transplantation of peripheral mononuclear cells into ischemic limb muscles, followed by administration of adrenomedullin.
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 rest pain, non-healing ischemic ulcers, and/or intermittent claudication. 2)Significant stenosis in superficial femoral, popliteal, and/or below knee arteries by DSA, CTA, and/or MRA. 3)Patients who are not candidates for angioplasty or bypass surgery. 4)Written informed consent.
Key exclusion criteria	1)malignant disorder. 2)uncontrolled liver disorder. 3)acute myocardial infarction, unstable angina, myocarditis, cerebral infarction within one month. 4)active infection. 5)pregnancy or child bearing potentials. 6)diabetic retinopathy (untreated proliferative retinopathy).
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Nakatani
Organization	National Cardiovascular Center
Division name	Department of Organ Transplantation
Zip code
Address	5-7-1 Fujishiro-dai, Suita, Osaka
TEL	06-6833-5012
Email

Public contact
Name of contact person	1st name Middle name Last name Satoshi Takeshita
Organization	National Cardiovascular Center
Division name	Cardiology
Zip code
Address
TEL	06-6833-5012
Homepage URL
Email

Sponsor
Institute	National Cardiovascular Center
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
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	2005 Year 09 Month 13 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	One out of 6 patients exhibited allergic reaction-like symptoms, and wediscontinued administration of the test drug to this patient, afterwards he hadgotten free from those symptoms. The Safety Committee assessed the causal relationship between theallergic reaction-like symptoms and the test drug, and it was concluded that thepatients was in extremely nervous situation, and this might have influenced tothe occurrence of those symptoms. This trial was completed without any severe adverse events.
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	2004 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2004 Year 08 Month 01 Day
Last follow-up date	2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 09 Month 13 Day
Last modified on	2011 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000186

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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