Safety and efficacy of ixmyelocel-T an expanded, autologous multi-cellular therapy, in dilated cardiomyopathy

Circulation Research

Volumn 115, Issue 8, 2014, Pages 730-737

  Henry, Timothy D ^a,b   Traverse, Jay H ^c   Hammon, Baron L ^d   East, Cara A ^e   Bruckner, Brian ^f   Remmers, Ann E ^h   Recker, David ^g   Bull, David A ^h   Patel, Amit N ^g  

^a CEDARS SINAI MEDICAL CENTER   (United States)

^b Department of Internal Medicine Division of Cardiology   (United States)

^c MINNEAPOLIS HEART INSTITUTE FOUNDATION   (United States)

^d Division of Cardiothoracic Surgery   (United States)

^e BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^f HOUSTON METHODIST HOSPITAL   (United States)

^g UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^h Aastrom Biosciences Inc   (United States)

Author keywords

Cardiomyopathy, dilated; Clinical trial; Heart failure; Stem cell

Indexed keywords

IXMYELOCEL T;

ADULT; AGED; ARTICLE; BONE MARROW BIOPSY; CARDIOVASCULAR DISEASE; CLINICAL ARTICLE; CONGESTIVE CARDIOMYOPATHY; CONSTIPATION; CONTROLLED STUDY; DISEASE EXACERBATION; DRUG EFFICACY; DRUG SAFETY; ENDOCARDIAL INJECTION CATHETER; FEMALE; HEART FAILURE; HEART MUSCLE ISCHEMIA; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOTENSION; MALE; MINNESOTA LIVING WITH HEART FAILURE QUESTIONNAIRE; MULTICENTER STUDY; NAUSEA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; THORACOTOMY; WALKING; ADVERSE EFFECTS; AUTOTRANSPLANTATION; BIOLOGICAL THERAPY; CARDIOMYOPATHY, DILATED; CATHETER; CELL TRANSPLANTATION; CLINICAL TRIAL; FOLLOW UP; HEART FUNCTION TEST; HEART MUSCLE; ISCHEMIA; MIDDLE AGED; PATHOLOGY; PATHOPHYSIOLOGY; PROCEDURES; SINGLE PHOTON EMISSION COMPUTER TOMOGRAPHY; TREATMENT OUTCOME;

AGED; CARDIOMYOPATHY, DILATED; CATHETERS; CELL TRANSPLANTATION; CELL- AND TISSUE-BASED THERAPY; FEMALE; FOLLOW-UP STUDIES; HEART FUNCTION TESTS; HUMANS; ISCHEMIA; MALE; MIDDLE AGED; MYOCARDIUM; PROSPECTIVE STUDIES; TOMOGRAPHY, EMISSION-COMPUTED, SINGLE-PHOTON; TRANSPLANTATION, AUTOLOGOUS; TREATMENT OUTCOME;

EID: 84921801765     PISSN: 00097330     EISSN: 15244571     Source Type: Journal    
DOI: 10.1161/CIRCRESAHA.115.304554     Document Type: Article

References (25)

1. Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Piña IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013;6:606-619.
2. Starling RC. Epidemiology of heart failure: progression to pandemic? In: McCarthy PM, Young JB, eds. Heart Failure: A Combined Medical and Surgical Approach. Carlton: Blackwell Science Ltd; 2007:1-8.
3. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart Failure. 2013;62:e147-239.
4. Losordo DW, Dimmeler S. Therapeutic angiogenesis and vasculogenesis for ischemic disease: part II: cell-based therapies. Circulation. 2004;109: 2692-2697.
5. Jeevanantham V, Butler M, Saad A, Abdel-Latif A, Zuba-Surma EK, Dawn B. Adult bone marrow cell therapy improves survival and induces long-term improvement in cardiac parameters: a systematic review and meta-analysis. Circulation. 2012;126:551-568.
6. Fisher SA, Dorée C, Brunskill SJ, Mathur A, Martin-Rendon E. Bone Marrow Stem cell treatment for ischemic heart disease in patients with no option of revascularization: a systematic review and meta-analysis. PLoS One. 2013;8:e64669.
7. Kandala J, Upadhyay GA, Pokushalov E, Wu S, Drachman DE, Singh JP. Meta-analysis of stem cell therapy in chronic ischemic cardiomyopathy. Am J Cardiol. 2013;112:217-225.
8. Perin EC, Willerson JT, Pepine CJ, et al; Cardiovascular Cell Therapy Research Network (CCTRN). Effect of transendocardial delivery of autologous bone marrow mononuclear cells on functional capacity, left ventricular function, and perfusion in chronic heart failure (the FOCUSCCTRN trial). JAMA. 2012;307:1717-1726.
9. Stolzing A, Jones E, McGonagle D, Scutt A. Age-related changes in human bone marrow-derived mesenchymal stem cells: consequences for cell therapies. Mech Ageing Dev. 2008;129:163-173.
10. Maijenburg MW, Kleijer M, Vermeul K, Mul EP, van Alphen FP, van der Schoot CE, Voermans C. The composition of the mesenchymal stromal cell compartment in human bone marrow changes during development and aging. Haematologica. 2012;97:179-183.
11. Hare JM, Fishman JE, Gerstenblith G, et al. Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012;308:2369-2379.
12. Makkar RR, Smith RR, Cheng K, Malliaras K, Thomson LE, Berman D, Czer LS, Marbán L, Mendizabal A, Johnston PV, Russell SD, Schuleri KH, Lardo AC, Gerstenblith G, Marbán E. Intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction (CADUCEUS): a prospective, randomised phase 1 trial. Lancet. 2012;379:895-904.
13. Bolli R, Chugh AR, D'Amario D, et al. Cardiac stem cells in patients with ischaemic cardiomyopathy (SCIPIO): initial results of a randomised phase 1 trial. Lancet 2011; 378: 1847-1857.
14. Losordo DW, Henry TD, Davidson C, et al; the ACT34-CMI Investigators. Intramyocardial, autologous CD34+ cell therapy for refractory angina. Circ Res. 2011;109(4):428-36.
15. Bartunek J, Behfar A, Dolatabadi D, et al. Cardiopoietic stem cell therapy in heart failure: the C-CURE (Cardiopoietic stem Cell therapy in heart failURE) multicenter randomized trial with lineage-specified biologics. J Am Coll Cardiol 2013;61:2329-2338.
16. Bartel RL, Cramer C, Ledford K, Longcore A, Parrish C, Stern T, Watling S, Zeigler F. The Aastrom Experience. Stem Cell Res Ther. 2012;3:26.
17. Ledford KJ, Zeigler F, Bartel, RL. Ixmyelocel-T, an expanded multicellular therapy, contains a unique population of M2-like macrophages. Stem Cell Res Ther. 2013;4:134.
18. Ledford KJ, Murphy N, Zeigler F, Bartel, RL. Potential beneficial effects of ixmyelocel-T in the treatment of atherosclerotic diseases. Stem Cell Res Ther. 2013;4:136.
19. Powell RJ, Marston WA, Berceli SA, Guzman R, Henry TD, Longcore AT, Stern TP, Watling S, Bartel RL. Cellular therapy with Ixmyelocel-T to treat critical limb ischemia: the randomized, double-blind, placebocontrolled RESTORE-CLI trial. Mol Ther. 2012;20:1280-1286.
20. Richardson P, McKenna W, Bristow M, Maisch B, Mautner B, O'Connell J, Olsen E, Thiene G, Goodwin J, Gyarfas I, Martin I, Nordet P. Report of the 1995 World Health Organization/International Society and Federation of Cardiology Task Force on the Definition and Classification of cardiomyopathies. Circulation. 1996;93:841-842.
21. Kornowski R, Hong MK, Leon MB. Comparison between left ventricular electromechanical mapping and radionuclide perfusion imaging for detection of myocardial viability. Circulation. 1998;98:1837-1841.
22. van Weel V, van Tongeren RB, van Hinsbergh VW, van Bockel JH, Quax PH. Vascular growth in ischemic limbs: a review of mechanisms and possible therapeutic stimulation. Ann Vasc Surg. 2008;22:582-597.
23. Shireman PK. The chemokine system in arteriogenesis and hind limb ischemia. J Vasc Surg 2007, 45:A48-A56.
24. Troidl C, Jung G, Troidl K, Hoffmann J, Mollmann H, Nef H, Schaper W, Hamm CW, Schmitz-Rixen T. The temporal and spatial distribution of macrophage subpopulations during arteriogenesis. Curr Vasc Pharmacol. 2013;11:5-12.
25. Jeong H, Yim HW, Cho Y, Park HJ, Jeong S, Kim H-b, Hong W, Kim H. The effect of rigorous study design in the research of autologous bone marrowderived mononuclear cell transfer in patients with acute myocardial infarction. Stem Cell Res Ther. 2013;4:82. http://stemcellres.com/content/4/4/82.