Unique ID issued by UMIN | UMIN000021374 |
---|---|
Receipt number | R000024652 |
Scientific Title | Ex Vivo Expanded Erythroblast-Transplantation for patient with critical limb ischemia |
Date of disclosure of the study information | 2016/03/07 |
Last modified on | 2021/09/23 10:06:26 |
Ex Vivo Expanded Erythroblast-Transplantation for patient with critical limb ischemia
EVEETA study
Ex Vivo Expanded Erythroblast-Transplantation for patient with critical limb ischemia
EVEETA study
Japan |
Peripheral Arterial Disease (PAD) , Buerger disease, and arteritis associated with collagen diseases (Fontaines stage: III and IV)
Cardiology |
Others
NO
To investigated the safety and efficacy of angiogenic cell therapy by implantation of ex vivo expanded immature erythroblasts cultured from autologous bone marrow cells for patient with critical limb ischemia
Safety,Efficacy
improvement of skin perfusion pressure level at ischemic leg 1 month after EVEETA
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
1)Autologous Bone Marrow Collection: 40 to 60 ml of bone marrow is collected from iliaccrest under local anaesthesia 14 days before the implantation.
2)Ex vivo expanded immature erythroblasts from autologous bone marrow cells : All procedures are enforced by exclusive
technical exparts along the approved protocols in GMP-grade Cell Processing Room established in Bioscience Medical Research Center, Niigata University Medical and Dental Hospital. Mononuclear cells separated from the bone marrow are incubated in a suspension culture in the presence of rh Flt-ligand, rh SCF, rh Thrombopoietin, and culture supplements for 7 days to expand myeloid progenitors. Harvested and washed cells are further cultured in the presence of rh SCF, rh IGF-I, rh Erythropoietin, and culture supplements for additional 7 days to expand immature erythroblasts and macrophages. Cultured cells are finally harvested, washed, suspended in 50 ml of autologous platelet rich plasma, and transferred from the bio clean room to bedside.
3)Transplantation of cultured cell: Aliquots of the 50 ml of cell suspension are intramuscularly injected in 100 points of the ischaemic limb. Daily intramuscular injection of 6000 IU of rh erythropoietin in the same loci follows from day 0 for consecutive 5 days.
20 | years-old | <= |
80 | years-old | >= |
Male and Female
Peripheral Arterial Disease (PAD) , Buerger disease, and arteritis associated with collagen diseases
1. Fontaines stage: III and IV
2. Patient with critical limb ischemia, who were not candidates for endovascular treatment /surgical revascularisation, or skin perfusion pressure<40mmHg at ischemic leg even after endovascular treatment /surgical revascularisation
4. Age: greater than 20 or less than 80 years
1. Patients with the expected rest of their life less than 1 year
2. Patients with drug dependence during the past 3 months
3. Patients with malignant evidence of malignant disorder during the past 5 years
4. Patients with poorly controlled diabetes mellitus accompanied with proliferative retinopathy
5. Patients with polycythemia; Hematcrit >55%(male), >50%(female)
6. Patients without informed consent
7. Pregnant or possibly pregnant females
8. Patients with acute myocardial infarction, unstable angina, myocarditis, or cerebral infarction during the past 1 month
9. Patients with active infection including Treponema pallidum, or positive test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
10. Patients with history of allergy for antibiotics
11. Patients with anemia or thrombocytopenia
12. Patients judged inappropriate for this study by phisician
13. Patients without agreement for including in this study
11
1st name | Tohru |
Middle name | |
Last name | Minamino |
Niigata University Graduate School of Medical and Dental Sciences
Department of Cardiovascular Biology and Medicine
9518510
1-754 Asahimachi-Dori, Niigata, Japan
0252272185
tminamino@med.niigata-u.ac.jp
1st name | Takao |
Middle name | |
Last name | Yanagawa |
Niigata University Graduate School of Medical and Dental Sciences
Department of Cardiovascular Biology and Medicine
9518510
1-754 Asahimachi-Dori, Niigata, Japan
0252272185
takao-ya@med.niigata-u.ac.jp
EVEETA Study Group
JSPS KAKENHI Grant Numbers 15K09117
Japanese Governmental office
Kyushu University Hospitals Specially Certified Committee for Regenerative Medicine
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, JAPAN
092-642-5774
byskenkyu@jimu.kyushu-u.ac.jp
NO
2016 | Year | 03 | Month | 07 | Day |
Unpublished
Terminated
2015 | Year | 08 | Month | 20 | Day |
2016 | Year | 01 | Month | 28 | Day |
2016 | Year | 03 | Month | 07 | Day |
2020 | Year | 06 | Month | 30 | Day |
2020 | Year | 06 | Month | 30 | Day |
2020 | Year | 06 | Month | 30 | Day |
2020 | Year | 06 | Month | 30 | Day |
2016 | Year | 03 | Month | 07 | Day |
2021 | Year | 09 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024652
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |