UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000939 |
|---|---|
| Receipt number | R000001125 |
| Scientific Title | Multicenter trial of therapeutic angiogenesis in patients with intractable vasculitis |
| Date of disclosure of the study information | 2007/12/10 |
| Last modified on | 2010/06/09 17:12:31 |
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Basic information
Public title
Multicenter trial of therapeutic angiogenesis in patients with intractable vasculitis
Acronym
Therapeutic angiogenesis in intractable vasculitis
Scientific Title
Multicenter trial of therapeutic angiogenesis in patients with intractable vasculitis
Scientific Title:Acronym
Therapeutic angiogenesis in intractable vasculitis
Region
| Japan |
Condition
Condition
Intractable vasculitis
Classification by specialty
| Cardiology | Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy and safety of therapeutic angiogenesis using autologous bone marrow or peripheral blood mononuclear cells in patients with intractable vasculitis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amputation, Pain scale, Ischemic ulcer size
Key secondary outcomes
Clinical symptom (numbness, coldness), Skin temperature, Blood flow (Lazer Doppler image, angiography)
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
| Maneuver |
Interventions/Control_1
Implantation of bone marrow or peripheral blood mononuclear cells
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Intractable vasculitis patients with severe peripheral ischemia resistant to conventional therapies.
Key exclusion criteria
Patients with malignancy or severe diabetic retinopathy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uichi Ikeda |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1, Asahai, Matsumoto, Nagano 390-8621, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Izawa |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-1, Asahai, Matsumoto, Nagano 390-8621, Japan
TEL
Homepage URL
izawa611@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Shinshu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2007 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Date of protocol fixation
| 2004 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | 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
| 2007 | Year | 12 | Month | 07 | Day |
Last modified on
| 2010 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001125
