UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000330 |
|---|---|
| Receipt number | R000000377 |
| Scientific Title | Peripheral blood mononuclear cell therapy in PAD patients with intermittent claudication randamized trial |
| Date of disclosure of the study information | 2006/02/15 |
| Last modified on | 2013/08/14 14:31:05 |
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Basic information
Public title
Peripheral blood mononuclear cell therapy in PAD patients with intermittent claudication randamized trial
Acronym
PB-MNC therapy (PERTINENT) trial
Scientific Title
Peripheral blood mononuclear cell therapy in PAD patients with intermittent claudication randamized trial
Scientific Title:Acronym
PB-MNC therapy (PERTINENT) trial
Region
| Japan |
Condition
Condition
ASO/Buerger disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of PB-MNC therapy in PAD patients with IC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Maximum walking distance, Pain-free walking distance, Recovery time of lower leg BP after exercise, ABPI at 6 months after treatment as compared with those before treatment
Key secondary outcomes
Laser doppler image, Scintigraphy, MRI, Angiography, QOL estimation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PB-MNC implantation
Interventions/Control_2
Saline
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
PAD patients presenting with severe IC resistant to conventional therapies
Key exclusion criteria
Patients with malignant diseases, severe diabetic retinopathy, or severe renal failure.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Issei Komuro |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Science and Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2097
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tohru Minamino |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovascular Science and Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
043-226-2964
Homepage URL
t_minamino@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiovascular Science and Medicine, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2006 | Year | 02 | Month | 15 | 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
| 2006 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | 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
| 2006 | Year | 02 | Month | 14 | Day |
Last modified on
| 2013 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000377
