Safety and efficacy of autologous skeletal myoblast sheets (TCD-51073) for the treatment of severe chronic heart failure due to ischemic heart disease

Circulation Journal

Volumn 79, Issue 5, 2015, Pages 992-999

  Sawa, Yoshiki ^a   Yoshikawa, Yasushi ^a   Toda, Koichi ^a   Fukushima, Satsuki ^a   Yamazaki, Kenji ^b,c   Ono, Minoru ^d   Sakata, Yasushi ^a   Hagiwara, Nobuhisa ^c   Kinugawa, Koichiro ^d   Miyagawa, Shigeru ^a  

^a Department of Cardiovascular Surgery ^*  (Japan)

^b OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^d UNIVERSITY OF TOKYO   (Japan)

Author keywords

Heart failure; Multicenter study; Myoblast sheets; Regenerative therapy

Indexed keywords

ADULT; AGED; ARTICLE; AUTOLOGOUS SKELETAL MYOBLAST SHEET; BLOOD POOL SCINTISCANNING; CLINICAL ARTICLE; COLON CANCER; ECHOCARDIOGRAPHY; FEVER; HEART ARRHYTHMIA; HEART FAILURE; HEART FUNCTION; HEART LEFT VENTRICLE EJECTION FRACTION; HEART LEFT VENTRICLE ENDDIASTOLIC VOLUME; HEART VENTRICLE TACHYCARDIA; HUMAN; HYPOKALEMIA; ISCHEMIC HEART DISEASE; MALE; MULTICENTER STUDY; MYOBLAST; NEW YORK HEART ASSOCIATION CLASS; PHASE 2 CLINICAL TRIAL; SAFETY; TRANSPLANTATION; WOUND COMPLICATION; AUTOGRAFT; CHRONIC DISEASE; CLINICAL TRIAL; COMPLICATION; FEMALE; FOLLOW UP; HEART STROKE VOLUME; MIDDLE AGED; MYOCARDIAL ISCHEMIA; PATHOPHYSIOLOGY;

ADULT; AGED; AUTOGRAFTS; CHRONIC DISEASE; FEMALE; FOLLOW-UP STUDIES; HEART FAILURE; HUMANS; MALE; MIDDLE AGED; MYOBLASTS, SKELETAL; MYOCARDIAL ISCHEMIA; STROKE VOLUME;

EID: 84928473829     PISSN: 13469843     EISSN: 13474820     Source Type: Journal    
DOI: 10.1253/circj.CJ-15-0243     Document Type: Article

References (19)

1. Imamura T, Kinugawa K, Hatano M, Fujino T, Inaba T, Maki H, et al. Status 2 patients had poor prognosis without mechanical circulatory support. Circ J 2014; 78: 1396-1404
2. Sakaguchi T, Matsumiya G, Yoshioka D, Miyagawa S, Nishi H, Yoshikawa Y, et al. DuraHeartTM magnetically levitated left ventricular assist device: Osaka University experience. Circ J 2013; 77: 1736-1741
3. Sanganalmath SK, Bolli R. Cell therapy for heart failure: A comprehensive overview of experimental and clinical studies, current challenges, and future directions. Circ Res 2013; 113: 810-834
4. Dib N, McCarthy P, Campbell A, Yeager M, Pagani FD, Wright S, et al. Feasibility and safety of autologous myoblast transplantation in patients with ischemic cardiomyopathy. Cell Transplant 2005; 14: 11-19
5. Duckers HJ, Houtgraaf J, Hehrlein C, Schofer J, Waltenberger J, Gershlick A, et al. Final results of a phase IIa, randomised, openlabel trial to evaluate the percutaneous intramyocardial transplantation of autologous skeletal myoblasts in congestive heart failure patients: The SEISMIC trial. EuroIntervention 2011; 6: 805-812
6. Menasche P, Alfieri O, Janssens S, Mc Kenna W, Reichenspurner H, Trinquart L, et al. The Myoblast Autologous Grafting in Ischemic Cardiomyopathy (MAGIC) trial: First randomized placebo-controlled study of myoblast transplantation. Circulation 2008; 117: 1189-1200
7. Miyagawa S, Saito A, Sakaguchi T, Yoshikawa Y, Yamauchi T, Imanishi Y, et al. Impaired myocardium regeneration with skeletal cell sheets: A preclinical trial for tissue-engineered regeneration therapy. Transplantation 2010; 90: 364-372
8. Kondoh H, Sawa Y, Miyagawa S, Sakakida-Kitagawa S, Memon IA, Kawaguchi N, et al. Longer preservation of cardiac performance by sheet-shaped myoblast implantation in dilated cardiomyopathic hamsters. Cardiovasc Res 2006; 69: 466-475
9. Hata H, Matsumiya G, Miyagawa S, Kondoh H, Kawaguchi N, Matsuura N, et al. Grafted skeletal myoblast sheets attenuate myocardial remodeling in pacing-induced canine heart failure model. J Thorac Cardiovasc Surg 2006; 132: 918-924
10. Memon IA, Sawa Y, Fukushima N, Matsumiya G, Miyagawa S, Taketani S, et al. Repair of impaired myocardium by means of implantation of engineered autologous myoblast sheets. J Thorac Cardiovasc Surg 2005; 130: 1333-1341
11. Shudo Y, Miyagawa S, Nakatani S, Fukushima S, Sakaguchi T, Saito A, et al. Myocardial layer-specific effect of myoblast cell-sheet implantation evaluated by tissue strain imaging. Circ J 2013; 77: 1063-1072
12. Sawa Y, Miyagawa S, Sakaguchi T, Fujita T, Matsuyama A, Saito A, et al. Tissue engineered myoblast sheets improved cardiac function sufficiently to discontinue LVAS in a patient with DCM: Report of a case. Surg Today 2012; 42: 181-184
13. Jessup M, Greenberg B, Mancini D, Cappola T, Pauly DF, Jaski B, et al; Calcium Upregulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID) Investigators. Calcium Upregulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID): A phase 2 trial of intracoronary gene therapy of sarcoplasmic reticulum Ca2+-AT Pase in patients with advanced heart failure. Circulation 2011; 124: 304-313
14. Shiba N, Nochioka K, Miura M, Kohno H, Shimokawa H; CHART-2 Investigators. Trend of westernization of etiology and clinical characteristics of heart failure patients in Japan: First report from the CHART-2 study. Circ J 2011; 75: 823-833
15. US Food and Drug Administration. Guidance for industry: Cellular therapy for cardiac disease. FDA, MD, October 2010. Available from www.fda.gov [Guidance, Compliance & Regulatory Information] (accessed April 9, 2015)
16. Revision of “Guidelines on Clinical Evaluation of Drugs to Treat Heart Failure”, Notification No. 0329 [18] of the Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, March 29, 2011. Available from: http://www.pmda.go.jp/files/000157362.pdf (accessed April 9, 2015)
17. Hare JM, Bolli R, Cooke JP, Gordon DJ, Henry TD, Perin EC, et al. Cardiovascular Cell Therapy Research Network. 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 2013; 127: 1630-1635
18. Menasche P, Hagege AA, Vilquin JT, Desnos M, Abergel E, Pouzet B, et al. Autologous skeletal myoblast transplantation for severe postinfarction left ventricular dysfunction. J Am Coll Cardiol 2003; 41: 1078-1083
19. Narita T, Shintani Y, Ikebe C, Kaneko M, Harada N, Tshuma N, et al. The use of cell-sheet technique eliminates arrhythmogenicity of skeletal myoblast-based therapy to the heart with enhanced therapeutic effects. Int J Cardiol 2013; 168: 261-269.