Abstract
In Israel, as elsewhere in the world, people with vascular disease suffer severe complications, including critical limb ischemia, which can result in gangrene and amputation. This chapter describes the step-wise progression in translational medical research as a scientific breakthrough progresses from a laboratory invention to the start of a clinical trial. The novel idea is a method whereby a sub-population of non-mobilized peripheral blood cells can be turned, within a day, into a cellular therapeutic product code-named BGC101, composed of endothelial progenitor cells (EPCs) and Stem/progenitor cell (SPCs). In addition, the benefits of collaboration between an Israeli biotechnology company and an Israeli medical center in overcoming the hurdles of bringing the idea to fruition will be described.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
CDC. Deaths final data for 2011. 2015. http://www.cdc.gov/nchs/data/nvsr/nvsr63/nvsr63_03.pdf. Accessed 27 July 2015.
Alwan, A. Global status report on non-communicable disease 2010, Geneva World Health Organization. 2011. http://www.who.int/nmh/publications/ncd_report_full_en.pdf.
Nichols M, Townsend N, Scarborough P, Rayner M. Cardiovascular disease in Europe 2014: epidemiological update. Eur Heart J. 2014;35:2950–9.
Mozaffarian D, Benjamin EJ, Go AS, et al. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation. 2015;131:e29–322.
Lumsden AB, Davies MG, Peden EK. Medical and endovascular management of critical limb ischemia. J Endovasc Ther. 2009;16:II31–62.
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FGR. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45:S5–67.
Peacock JM, Keo HH, Duval S, Baumgartner I, Oldenburg NC, Jaff MR, Henry TD, Yu X, Hirsch AT. The incidence and health economic burden of ischemic amputation in Minnesota, 2005–2008. Prev Chronic Dis. 2011;8(6):141. http://www.cdc.gov/pcd/issues/2011/nov/11_0023.htm.
Alonso A, Garcia LA. The costs of critical limb ischemia. Endovasc Today. 2011;2011:32–6.
Benoit E, O’Donnell TF, Kitsios GD, Iafrati MD. Improved amputation-free survival in unreconstructable critical limb ischemia and its implications for clinical trial design and quality measurement. J Vasc Surg. 2012;55:781–9.
Benoit E, O’Donnell TF, Patel AN. Safety and efficacy of autologous cell therapy in critical limb ischemia: a systematic review. Cell Transplant. 2013;22:545–62.
Fadini GP, Agostini C, Avogaro A. Autologous stem cell therapy for peripheral arterial disease meta-analysis and systematic review of the literature. Atherosclerosis. 2010;209:10–7.
Fuh E, Brinton TJ. Bone marrow stem cells for the treatment of ischemic heart disease: a clinical trial review. J Cardiovasc Transl Res. 2009;2:202–18.
Gratwohl A, Baldomero H, Aljurf M, Pasquini MC, Bouzas LF, Yoshimi A, Szer J, Lipton J, Schwendener A, Gratwohl M, et al. Hematopoietic stem cell transplantation: a global perspective. JAMA. 2010;303:1617–24.
Losordo DW, Siscovick DS, Manolio TA, Udelson JE, Veereshwarayya V, Durgin M, Poh KK, Weinstein R, Kearney M, Chaudhry M, Burg A, Eaton L, Heyd L, Thorne T, Shturman L, Hoffmeister P, Story K, Zak V, Dowling D, Traverse JH, Olson RE, Flanagan J, Sodano D, Murayama T, Kawamoto A, Kusano KF, Wollins J, Welt F, Shah P, Soukas P, Asahara T, Henry TD. Intramyocardial transplantation of autologous CD34+ stem cells for intractable angina: a phase I/IIa double-blind, randomized controlled trial. Circulation. 2007;115:3165–72.
Quirici N, Soligo D, Caneva L, Servida F, Bossolasco P, Deliliers GL. Differentiation and expansion of endothelial cells from human bone marrow CD133+ cells. Br J Haematol. 2001;115:186–94.
Porat Y, Assa-Kunik E, Belkin M, Krakovsky M, Lamensdorf I, Duvdevani R, Sivak G, Niven M, Bulvik S. A novel potential therapy for vascular diseases: blood-derived stem/progenitor cells specifically activated by dendritic cells. Diabetes Metab Res Rev. 2014;30:623–34.
U.S. Food and Drug Administration. 2011. Guidance for industry regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) small entity compliance guide. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/ucm062592.pdf. Accessed 21 Oct 2011.
European Medicines Agency. Advanced-therapy classification. 2015. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000296.jsp. Accessed 6 May 2015.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2017 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Porat, Y., Belkin, M., Bulvik, S., Frogel, M., Galili, O., Niven, M. (2017). Cell Therapy for Vascular Diseases in Israel. In: Dardik, A. (eds) Vascular Surgery. Springer, Cham. https://doi.org/10.1007/978-3-319-33745-6_23
Download citation
DOI: https://doi.org/10.1007/978-3-319-33745-6_23
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-33743-2
Online ISBN: 978-3-319-33745-6
eBook Packages: MedicineMedicine (R0)