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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000199
Receipt No. R000000186
Scientific Title Therapeutic angiogenesis for peripheral artery diseases by combination of adrenomedullin and peripheral mononuclear cell transplantation
Date of disclosure of the study information 2005/09/13
Last modified on 2011/09/06

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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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