Commercialization of trials for peripheral artery disease

Cytotherapy

Volumn 13, Issue 10, 2011, Pages 1157-1161

  Sherman, Warren ^a   Mazouz, Chaya ^b   Deans, Robert ^c   Patel, Amit N ^d  

^a NewYork Presbyterian Hospital   (United States)

^b Pluristem Therapeutics   (United States)

^c ATHERSYS INC   (United States)

^d UNIVERSITY OF UTAH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADIPOSE TISSUE; ANGIOGENESIS; ARTICLE; BONE MARROW; CELL THERAPY; CLINICAL FEATURE; CLINICAL PRACTICE; CLINICAL PROTOCOL; COMMERCIAL PHENOMENA; COST EFFECTIVENESS ANALYSIS; ENDOMETRIUM; HEALTH CARE COST; HUMAN; INTERMITTENT CLAUDICATION; LIMB ISCHEMIA; MEDICAL INFORMATION; OUTCOME ASSESSMENT; PATIENT SAFETY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; REGISTER; REVASCULARIZATION; STEM CELL; STEM CELL TRANSPLANTATION; UMBILICAL CORD BLOOD;

EID: 80054774332     PISSN: 14653249     EISSN: 14772566     Source Type: Journal    
DOI: 10.3109/14653249.2011.620795     Document Type: Article

References (12)

1. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, et al. ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): A collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006;113:e463 - 654.
2. Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, et al. Peripheral arterial disease detection, awareness, and treatment in primary care. J Am Med Ass. 2001;286:1317-24. (Pubitemid 33015522)
3. Asahara T, Masuda H, Takahashi T, Kalka C, Pastore C, Silver M, et al. Bone marrow origin of endothelial progenitor cells responsible for postnatal vasculogenesis in physiological and pathological neovascularization. Circ Res. 1999;85:221-8. (Pubitemid 29377293)
4. Kalka C, Masuda H, Takahashi T, Kalka-Moll WM, Silver M, Kearney M, et al. Transplantation of ex vivo expanded endothelial progenitor cells for therapeutic neovascularization. Proc Natl Acad Sci USA. 2000;97:3422-7. (Pubitemid 30183318)
5. Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, et al. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: A pilot study and a randomised controlled trial. Lancet. 2002;360:427-35.
6. Nguyen LL, Henry AJ. Disparities in vascular surgery: Is it biology or environment? J Vasc Surg. 2010;51(Suppl 4):36S - 41S.
7. Wrobel JS, Mayfi eld JA, Reiber GE. Geographic variation of lower-extremity major amputation in individuals with and without diabetes in the Medicare population. Diabetes Care. 2001 24 860-4. (Pubitemid 33636059)
8. Conte MS, Bandyk DF, Clowes AW, Moneta GL, Namini H, Seely L. Risk factors, medical therapies and perioperative events in limb salvage surgery: Observations from the PREVENT III multicenter trial. J Vasc Surg. 2005;42:456-65.
9. Vasa M, Fichtlscherer S, Aicher A, Adler K, Urbich C, Martin H, et al. Number and migratory activity of circulating endothelial progenitor cells inversely correlate with risk factors for coronary artery disease. Circ Res. 2001;89:E1 - 7.
10. Vasa M, Fichtlscherer S, Adler K, Aicher A, Martin H, Zeiher AM, et al. Increase in circulating endothelial progenitor cells by statin therapy in patients with stable coronary artery disease. Circulation. 2001;103:2885-90. (Pubitemid 32578123)
11. Heeschen C, Lehmann R, Honold J, Assmus B, Aicher A, Walter DH, et al. Profoundly reduced neovascularization capacity of bone marrow mononuclear cells derived from patients with chronic ischemic heart disease. Circulation. 2004;109:1615-22. (Pubitemid 38451717)
12. FDA. Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products. FDA Silver Spring Maryland, US; 2011.