UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001289 |
|---|---|
| Receipt number | R000001505 |
| Scientific Title | Peripheral blood mononuclear cell implantation for patients with severe ischemic heart disease |
| Date of disclosure of the study information | 2008/08/03 |
| Last modified on | 2008/12/01 15:38:18 |
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Basic information
Public title
Peripheral blood mononuclear cell implantation for patients with severe ischemic heart disease
Acronym
PROCEED
Scientific Title
Peripheral blood mononuclear cell implantation for patients with severe ischemic heart disease
Scientific Title:Acronym
PROCEED
Region
| Japan |
Condition
Condition
Severe ischemic heart disease
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of this treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety throughout this treatment.
Key secondary outcomes
Improvement of regional left ventriculer ejection fraction, gloval left ventriculer ejection fraction, perfusion, ischemic mitral regurgitation, symptom.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
CABG+injection of 10^7 autologous peripheral blood mononuclear cells
Interventions/Control_2
CABG+injection of 10^8 autologous peripheral blood mononuclear cells
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient with severe ischemic heart disease and remained ischemic area after CABG.
Key exclusion criteria
shock
emergency operation
malignant neoplasm
severe retinopathy
severe renal dysfunction(including who receiving chronic hemotherapy)
femail with pregnancy
others
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Issei Komuro |
Organization
Graduate School of Medicine,Chiba University
Division name
Department of Cardiovascular Science and Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-226-2555
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Minamino |
Organization
Graduate School of Medicine,Chiba University
Division name
Department of Cardiovascular Science and Medicine
Zip code
Address
TEL
Homepage URL
t_minamino@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiovascular Science and Medicine,Graduate School of Medicine,Chiba University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health,Labour and Welfare
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
| 2008 | Year | 08 | Month | 03 | 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
Date of protocol fixation
| 2008 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 03 | Day |
Last modified on
| 2008 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001505
