UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001597 |
|---|---|
| Receipt number | R000001916 |
| Scientific Title | Improvement of peripheral blood flow following autologous peripheral mononuclear cells transplantation in patients with peripheral arterial diseases |
| Date of disclosure of the study information | 2008/12/24 |
| Last modified on | 2012/04/17 10:41:22 |
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Basic information
Public title
Improvement of peripheral blood flow following autologous peripheral mononuclear cells transplantation in patients with peripheral arterial diseases
Acronym
Autologous peripheral mononuclear cells transplantation for peripheral arterial diseases
Scientific Title
Improvement of peripheral blood flow following autologous peripheral mononuclear cells transplantation in patients with peripheral arterial diseases
Scientific Title:Acronym
Autologous peripheral mononuclear cells transplantation for peripheral arterial diseases
Region
| Japan |
Condition
Condition
peripheral arterial diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on blood flow following intramuscular administration of peripheral mononuclear cells collected by blood separator in patients with peripheral arterial diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Subjective ischemic symptoms
Key secondary outcomes
Improvement of arterial blood flow
Neovascularization
Time to amputation
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
intramuscular administration of peripheral mononuclear cells collected by blood separator
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with arteriosclerosis obliterans diagnosed as Fontaine's classification III or IV, or patients with Buerger's disease
Patients who were disclosed their arterial disease and agreed with enrollment into the study by document
Key exclusion criteria
Patients intolerable for extracorporeal circulation
Congestive heart failure (ejection fraction <50%)
Renal failure (serum creatinine < 1.6 mg/dL)
Women on (possible) pregnancy or lactation
Patients judged inadequate by doctor in charge of the patient or the study
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ippei Sakamaki |
Organization
National Hospital Organization Awara Hospital
Division name
Department of Internal Medicine
Zip code
Address
238-1 Kitagata, Awara, Fukui 910-4272, Japan
TEL
0776-79-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuaki Tanaka |
Organization
National Hospital Organization Awara Hospital
Division name
Department of Pharmacy
Zip code
Address
238-1 Kitagata, Awara, Fukui 910-4272, Japan
TEL
0776-79-1211
Homepage URL
http://www.hosp.go.jp/~awara/kenkyu.html
nhoawara-secretary@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Awara Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Awara Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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 | 12 | Month | 24 | 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
| 2005 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 24 | Day |
Last modified on
| 2012 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001916
