Unique ID issued by UMIN | UMIN000018594 |
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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 |
Clinical Study of Therapeutic Angiogenesis Using Hypoxic Preconditioned Peripheral Blood Mononuclear Cells
Clinical Study of Therapeutic Angiogenesis Using Hypoxic preconditioned PBMNCs
Clinical Study of Therapeutic Angiogenesis Using Hypoxic Preconditioned Peripheral Blood Mononuclear Cells
Clinical Study of Therapeutic Angiogenesis Using Hypoxic preconditioned PBMNCs
Japan |
Peripheral arterial occlusive disease
Vascular surgery |
Others
NO
To examine the safety of cell therapy for ischemic lower limb with hypoxic preconditioned peripheral blood mononuclear cells
Safety
Phase I
The incidence and severity of the adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Implantation of PBMNCs collected from peripheral blood and cultured under hypoxia for 24 h.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
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.
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.
7
1st name | |
Middle name | |
Last name | Kimikazu Hamano |
Yamaguchi University Graduate School of Medicine
Department of Surgery and Clinical Science
Minamikogushi1-1-1, Ube, Yamaguchi, Japan
0836-22-2261
kimikazu@yamaguchi-u.ac.jp
1st name | |
Middle name | |
Last name | Makoto Samura |
Yamaguchi University Graduate School of Medicine
Department of Surgery and Clinical Science
Minamikogushi1-1-1, Ube, Yamaguchi, Japan
0836-22-2261
m.samura@yamaguchi-u.ac.jp
Yamaguchi University Graduate School of Medicine
Department of Surgery and Clinical Science
Yamaguchi University Graduate School of Medicine
Department of Surgery and Clinical Science
Self funding
NO
2015 | Year | 08 | Month | 07 | Day |
Unpublished
Terminated
2014 | Year | 04 | Month | 22 | Day |
2015 | Year | 08 | Month | 07 | Day |
2015 | Year | 08 | Month | 07 | Day |
2016 | Year | 03 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021031
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