Unique ID issued by UMIN | UMIN000009943 |
---|---|
Receipt number | R000011647 |
Scientific Title | Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease |
Date of disclosure of the study information | 2013/12/01 |
Last modified on | 2017/02/05 17:10:43 |
Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Vascular regeneration using autologous mesenchymal stem cells for peripheral arterial disease
Japan |
Peripheral Arterial Disease (Fontaine stages three and four)
Cardiology | Vascular surgery | Orthopedics |
Cardiovascular surgery |
Others
NO
We have reported that mesenhymal stem cells (MSC)could differentiate into vascular endothelial cells and produce vascular endothelial grows factor.The aim of this study is to investigate the efficacy and safety of culture expanded MSC for the treatments of peripheral artery disease. The MSC is derived from small amount(about 20ml) of patient's bone marrow cells and will be injected into the same patient's limb
Safety,Efficacy
Confirmatory
Explanatory
Phase I,II
ABI(Ankle Brechial Pressure Index): 7days, 1,6 and 12 months post transplantation.
Angiography : 12 months post transplantation.
Walking time without pain using tredmil: 1, 6 and 12 months post transplantation
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Bone marrow of about 20ml is taken from the patient. The bone marrow is transferred to National Institute of Advanced Industrial Science and Technology (AIST) at Amagasaki city and cultured to expand the mesenchymal stem cell. The stem cell is transferred back to the hospital. Half ml of mesenchymal stem cells (2.5 x 106 cells/ml) is injected into ischemic area of lower extremity. The injection sites per extremity are about 40. When both extremities show ischemic change, more severe extremity is selected. If some clinical effect after the injection appear but not satisfactory, several repeated injection will be done, furthermore, if injection into other extremity is thought to be effective, another injection is done for this extremity. Total duration of the injection is within a half year after the first injection of the MSCs.
20 | years-old | <= |
Not applicable |
Male and Female
(1) Peripheral Artery Disease: PAD
(2) Fontaine stages III and IV (ABI less than 0.6)
(3) The patient showing contraindications of angioplasty and bypass surgery due to spread areas of stricture or the stricture in small peripheral artery. Patients already treated with such angioplasty and bypass surgery, but showing the symptoms corresponding to above category (2).
(4) The patients by whom written consent is got from himself/herself by aged 20 and over (at the time of consent acquisition).
(1) The patient of hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) infection, and adult T-cell leukemia
(2) The hypersensitivity to a cow or pig origin protein, the patient that has the past of side effects
(3) The patient showing severe cardiac failure evidenced by cardiac echo examination.
(4) Malignant diseases.
(5) High-risk retinopathy
(6) Serious problems of liver and renal function
(7) Interstitial pneumonia.
(8) Blood diseases such as anemia and leykocytosis.
(9) A pregnant woman, a nursing mother, the patient that may have become pregnant, the female patient who is planning pregnancy by the end of this treatment term.
(10) In addition, the patient whom the principal investigator or the researcher judged to be unsuitable based on the medical rationale
5
1st name | |
Middle name | |
Last name | Hajime Ohgushi |
Ookuma Hospital
Department of Orthopedics
2-17-13 Kuise-honmachi, Amagasaki City, Hyogo 660-0814, JAPAN
06+64811667
1st name | |
Middle name | |
Last name | Hiroaki Narita |
Rogenkai Welfare Group
Headquarters
4-27-6 Higashi- sonoda -cho, Amagasaki, City, Hyogo 661-0953, JAPAN
06+64158590
narita@ookuma.or.jp
Rogenkai Welfare Group
National Institute of Advanced Industrial Science and Technology (AIST)
National Institute of Advanced Industrial Science and Technology (AIST)
NO
2013 | Year | 12 | Month | 01 | Day |
Unpublished
Completed
2013 | Year | 02 | Month | 03 | Day |
2014 | Year | 01 | Month | 21 | Day |
2016 | Year | 11 | Month | 12 | Day |
2016 | Year | 11 | Month | 12 | Day |
2013 | Year | 02 | Month | 03 | Day |
2017 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011647