Rationale and design for PACE: Patients with intermittent claudication injected with ALDH bright cells

American Heart Journal

Volumn 168, Issue 5, 2014, Pages 667-673.e2

  Perin, Emerson C ^a   Murphy, Michael ^b   Cooke, John P ^c   Moyé, Lem ^d,l   Henry, Timothy D ^e   Bettencourt, Judy ^d   Gahremanpour, Amir ^a   Leeper, Nicholas ^f   Anderson, R David ^g   Hiatt, William R ^h   Lima, Joao A ⁱ   Venkatesh, Bharath ⁱ   Sayre, Shelly L ^d   Vojvodic, Rachel W ^d   Taylor, Doris A ^a   Ebert, Ray F ^j   Hirsch, Alan T ^k  

^a TEXAS HEART INSTITUTE   (United States)

^b INDIANA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c HOUSTON METHODIST RESEARCH INSTITUTE   (United States)

^d UNIVERSITY OF TEXAS SCHOOL OF PUBLIC HEALTH   (United States)

^e CEDARS SINAI MEDICAL CENTER   (United States)

^f STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^h UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

ⁱ JOHNS HOPKINS UNIVERSITY   (United States)

^j NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^k UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^l NONE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALDEHYDE DEHYDROGENASE;

ANKLE BRACHIAL INDEX; ARTERY OCCLUSION; ARTICLE; AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION; CLINICAL EFFECTIVENESS; COLLATERAL CIRCULATION; FOLLOW UP; GASTROCNEMIUS MUSCLE; HUMAN; INFRAINGUINAL ARTERY; INTERMITTENT CLAUDICATION; LEG ARTERY; LEG BLOOD FLOW; MUSCLE BLOOD FLOW; MUSCLE PERFUSION; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PATIENT SAFETY; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); STUDY DESIGN; WALKING; AUTOTRANSPLANTATION; COMPLICATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; ENZYMOLOGY; HEMATOPOIETIC STEM CELL; HEMATOPOIETIC STEM CELL TRANSPLANTATION; INTRAMUSCULAR DRUG ADMINISTRATION; LEG; METABOLISM; PERIPHERAL ARTERIAL DISEASE; PROCEDURES; RANDOMIZED CONTROLLED TRIAL; SCINTIGRAPHY; SKELETAL MUSCLE; TREATMENT OUTCOME; VASCULARIZATION;

ALDEHYDE DEHYDROGENASE; ANKLE BRACHIAL INDEX; DOUBLE-BLIND METHOD; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HEMATOPOIETIC STEM CELLS; HUMANS; INJECTIONS, INTRAMUSCULAR; INTERMITTENT CLAUDICATION; LEG; MAGNETIC RESONANCE IMAGING; MUSCLE, SKELETAL; PERFUSION IMAGING; PERIPHERAL ARTERIAL DISEASE; TRANSPLANTATION, AUTOLOGOUS; TREATMENT OUTCOME;

EID: 84908332709     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2014.07.021     Document Type: Article

References (29)

1. R. Gupta, and D.W. Losordo Cell therapy for critical limb ischemia: moving forward one step at a time Circ Cardiovasc Interv 4 2011 2 5
2. D.W. Losordo, M.R. Kibbe, and F. Mendelsohn A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia Circ Cardiovasc Interv 5 2012 821 830
3. W. Rosamond, K. Flegal, and K. Furie Heart disease and stroke statistics-2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee Circulation 117 2008 e25 e146
4. E.M. Mahoney, K. Wang, and H.H. Keo Vascular hospitalization rates and costs in patients with peripheral artery disease in the United States Circ Cardiovasc Qual Outcomes 3 2010 642 651
5. A.T. Hirsch, Z.J. Haskal, and N.R. Hertzer ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report Circulation 113 2006 e463 e654
6. J.W. Olin, and B.A. Sealove Peripheral artery disease: current insight into the disease and its diagnosis and management Mayo Clin Proc 85 2010 678 692
7. T. Asahara, T. Murohara, and A. Sullivan Isolation of putative progenitor endothelial cells for angiogenesis Science 275 1997 964 967
8. T. Ziegelhoeffer, B. Fernandez, and S. Kostin Bone marrow-derived cells do not incorporate into the adult growing vasculature Circ Res 94 2004 230 238
9. Y. Higashi, M. Kimura, and K. Hara Autologous bone-marrow mononuclear cell implantation improves endothelium-dependent vasodilation in patients with limb ischemia Circulation 109 2004 1215 1218
10. E.C. Perin, G. Silva, and A. Gahremanpour A randomized, controlled study of autologous therapy with bone marrow-derived aldehyde dehydrogenase bright cells in patients with critical limb ischemia Catheter Cardiovasc Interv 78 2011 1060 1067
11. E. Tateishi-Yuyama, H. Matsubara, and T. Murohara Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial Lancet 360 2002 427 435
12. T. Bartsch, M. Brehm, and T. Zeus Transplantation of autologous mononuclear bone marrow stem cells in patients with peripheral arterial disease (the TAM-PAD study) Clin Res Cardiol 96 2007 891 899
13. C. Zierold, M.A. Carlson, and U.C. Obodo Developing mechanistic insights into cardiovascular cell therapy: Cardiovascular Cell Therapy Research Network Biorepository Core Laboratory rationale Am Heart J 162 2011 973 980
14. A.P. Gee, S. Richman, and A. Durett Multicenter cell processing for cardiovascular regenerative medicine applications: the Cardiovascular Cell Therapy Research Network (CCTRN) experience Cytotherapy 12 2010 684 691
15. A. Kawamoto, H. Iwasaki, and K. Kusano CD34-positive cells exhibit increased potency and safety for therapeutic neovascularization after myocardial infarction compared with total mononuclear cells Circulation 114 2006 2163 2169
16. R.W. Storms, A.P. Trujillo, and J.B. Springer Isolation of primitive human hematopoietic progenitors on the basis of aldehyde dehydrogenase activity Proc Natl Acad Sci U S A 96 1999 9118 9123
17. B.J. Capoccia, D.L. Robson, and K.D. Levac Revascularization of ischemic limbs after transplantation of human bone marrow cells with high aldehyde dehydrogenase activity Blood 113 2009 5340 5351
18. H.S. White, L. Smith, and T. Gentry Mechanisms of action of human aldehyde dehydrogenase bright cells in therapy of cardiovascular diseases: expression analysis of angiogenic factors and aldehyde dehydrogenase isozymes J Stem Cell Res Ther S1 2011 1 9
19. E.C. Perin, G.V. Silva, and Y. Zheng Randomized, double-blind pilot study of transendocardial injection of autologous aldehyde dehydrogenase-bright stem cells in patients with ischemic heart failure Am Heart J 163 2012 415 421 [421.e1]
20. R.D. Simari, L.A. Moye, and S.I. Skarlatos Development of a network to test strategies in cardiovascular cell delivery: the NHLBI-sponsored Cardiovascular Cell Therapy Research Network (CCTRN) J Cardiovasc Transl Res 3 2010 30 36
21. B. Versluis, W.H. Backes, and M.G. van Eupen Magnetic resonance imaging in peripheral arterial disease: reproducibility of the assessment of morphological and functional vascular status Invest Radiol 46 2011 11 24
22. B. Versluis, M.H. Dremmen, and P.J. Nelemans Dynamic contrast-enhanced MRI assessment of hyperemic fractional microvascular blood plasma volume in peripheral arterial disease: initial findings PLoS One 7 2012 e37756
23. T.P. Murphy, D.E. Cutlip, and J.G. Regensteiner Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study Circulation 125 2012 130 139
24. E.P. Brass, W.R. Hiatt, and S. Green Skeletal muscle metabolic changes in peripheral arterial disease contribute to exercise intolerance: a point-counterpoint discussion Vasc Med 9 2004 293 301
25. J.M. Hare, R. Bolli, and J.P. Cooke Phase II clinical research design in cardiology: learning the right lessons too well - observations and recommendations from the Cardiovascular Cell Therapy Research Network (CCTRN) Circulation 127 2013 1630 1635
26. P. Huang, S. Li, and M. Han Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes Diabetes Care 28 2005 2155 2160
27. P.P. Huang, X.F. Yang, and S.Z. Li Randomised comparison of G-CSF-mobilized peripheral blood mononuclear cells versus bone marrow-mononuclear cells for the treatment of patients with lower limb arteriosclerosis obliterans Thromb Haemost 98 2007 1335 1342
28. R.B. Van Tongeren, J.F. Hamming, and W.E. Fibbe Intramuscular or combined intramuscular/intra-arterial administration of bone marrow mononuclear cells: a clinical trial in patients with advanced limb ischemia J Cardiovasc Surg (Torino) 49 2008 51 58
29. R.B. van Tongeren, J.F. Hamming, and S. le Cessie Limited value of digital subtraction angiography in the evaluation of cell-based therapy in patients with limb ischemia Int J Cardiovasc Imaging 26 2010 19 25