47. バージャー病 Buerger disease Clinical trials / Disease details
|1||JPRN-UMIN000021374||2016/03/07||07/03/2016||Ex Vivo Expanded Erythroblast-Transplantation for patient with critical limb ischemia||Ex Vivo Expanded Erythroblast-Transplantation for patient with critical limb ischemia - EVEETA study||Peripheral Arterial Disease (PAD) , Buerger disease, and arteritis associated with collagen diseases (Fontaines stage: III and IV)||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.
|EVEETA Study Group||NULL||Complete: follow-up complete||20years-old||80years-old||Male and Female||11||Not selected||Japan|