UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018594 |
|---|---|
| Receipt number | R000021031 |
| Scientific Title | Clinical Study of Therapeutic Angiogenesis Using Hypoxic Preconditioned Peripheral Blood Mononuclear Cells |
| Date of disclosure of the study information | 2015/08/07 |
| Last modified on | 2016/03/23 19:23:52 |
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Basic information
Public title
Clinical Study of Therapeutic Angiogenesis Using Hypoxic Preconditioned Peripheral Blood Mononuclear Cells
Acronym
Clinical Study of Therapeutic Angiogenesis Using Hypoxic preconditioned PBMNCs
Scientific Title
Clinical Study of Therapeutic Angiogenesis Using Hypoxic Preconditioned Peripheral Blood Mononuclear Cells
Scientific Title:Acronym
Clinical Study of Therapeutic Angiogenesis Using Hypoxic preconditioned PBMNCs
Region
| Japan |
Condition
Condition
Peripheral arterial occlusive disease
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety of cell therapy for ischemic lower limb with hypoxic preconditioned peripheral blood mononuclear cells
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
The incidence and severity of the adverse events
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Implantation of PBMNCs collected from peripheral blood and cultured under hypoxia for 24 h.
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
1. Patients with age 20 to 85 years.
2. Patients with Fontaine class III-IV symptoms.
3. Patients with not expected further improvement with recomended therapy.
4. Patients not adequate for conventional operative therapy.
5. Patients can provide written informed consent for study participation.
Key exclusion criteria
1. Patients suffering from bacterial infections such as treponema palladium, chlamydia, gonorrhea and tuberculosis.
2. Patients suffering from infections such as hepatitis B and C viruses, human immunodeficiency virus, human T lymphotropic virus type 1 and parvovirus B19.
3. Patients with sepsis or suspected with.
4. Patients with malignant neoplasm or history of malignant neoplasm treatmented within five years.
5. Patients with serious endocrine disorders such as uncontrolled thyroid disfunction.
6. Patients with blood disorders except for chronic kidney disease.
7. Patients with liver disease with Child-Pugh classification B or more.
8. Patients with transmissible spongiform encephalopathy or suspected with.
9. Patients with dementia with a a revised version Hasegawa dementia scale score smaller than 4.
10. Patient determined to be ineligible for this clinical study by research attending physician.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimikazu Hamano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
Minamikogushi1-1-1, Ube, Yamaguchi, Japan
TEL
0836-22-2261
kimikazu@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Samura |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Surgery and Clinical Science
Zip code
Address
Minamikogushi1-1-1, Ube, Yamaguchi, Japan
TEL
0836-22-2261
Homepage URL
m.samura@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Department of Surgery and Clinical Science
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine
Department of Surgery and Clinical Science
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
| 2015 | Year | 08 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 07 | Day |
Last modified on
| 2016 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021031
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
