UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029597 |
|---|---|
| Receipt number | R000033817 |
| Scientific Title | Revascularization by Peripheral Blood Mononuclear Cell Transplantation |
| Date of disclosure of the study information | 2017/10/17 |
| Last modified on | 2021/09/13 09:08:40 |
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Basic information
Public title
Revascularization by Peripheral Blood Mononuclear Cell Transplantation
Acronym
Revascularization by Peripheral Blood Mononuclear Cell Transplantation
Scientific Title
Revascularization by Peripheral Blood Mononuclear Cell Transplantation
Scientific Title:Acronym
Revascularization by Peripheral Blood Mononuclear Cell Transplantation
Region
| Japan |
Condition
Condition
Critical limb ischemia due to peripheral artery disease (critical limb ischemia) and Buerger's disease
Classification by specialty
| Medicine in general | Cardiology | Dermatology |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study is to demonstrate the benefit of peripheral blood mononuclear cell transplantation on critical limb ischemia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of skin perfusion pressure at 6 weeks after initial administration of peripheral blood mononuclear cell transplantation.
Key secondary outcomes
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
| Other |
Interventions/Control_1
The concentrated solution of the patien ts' mononuclear cells administered to th e affected limb with ulcer lesions by int ramuscular injection. Repeat again the same treatment after two weeks.
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 critical limb ischemia caused by peripheral artery disease or Burger's disease.
2) over 20 years old
3) patient who can take a informed con sent
Key exclusion criteria
1) Patients who have severe hypersensitivity or history of side effects to aphaeresis.
2) Patients who have malignant tumor or history of malignancy within the past 3 years.
3) Patients who have experienced acute myocardial infarction, unstable angina pectoris, myocarditis or cerebral infarction within 3 months.
4) Patients with active infection.
5) Patients who are pregnant or might be pregnant.
6) Patients with proliferative diabetic retinopathy (untreated, medium-term and late proliferative retinopathy)
the end of treatment example is excluded.
7) Patients with platelets less than 70,000 platelets in blood test just before apheresies.
8) Patients with less than serum albumin 2 mg/dL.
9) Patients who are judged inappropriate for this trial by their attending physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tsujita |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL
81-96-373-5175
tsujita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Fujisue |
Organization
Kumamoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
TEL
81-96-373-5175
Homepage URL
fujisues@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board or Independent Ethics Committee of Kumamoto University Graduate of Medicine
Address
1-1-1 Honjo, Chuo-ku, Kumamoto, Japan.
Tel
81-96-373-5657
byi-senshin@jimu.kumamoto-u.ac.jp
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
| 2017 | Year | 10 | Month | 17 | 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
6
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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 17 | Day |
Last modified on
| 2021 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033817
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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