小児心不全に対する再生医療からのアプローチ
「緒言」2010年7月に15歳未満の小児の臓器提供を可能にした改正臓器移植法が施行された. これにより小児の心臓移植の増加が予想されたが, 2014年12月末時点での15歳未満の脳死臓器提供からの小児心臓移植数は7例と少数にとどまっている. 臓器提供者の不足と2年近くになる長期の移植待機の根本的解決とはなっていないのが実情である. このような背景から小児末期心不全に対してはbreakthroughとなる新しい治療戦略が切望されている. 2011年から岡山大学では自己心臓内幹細胞移植療法の臨床研究を行っており, 第1相臨床研究 (Transcoronary Infusion of Cardiac...
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| Published in | Japanese Journal of Transplantation Vol. 50; no. 6; pp. 565 - 575 |
|---|---|
| Main Authors | , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
一般社団法人 日本移植学会
2015
日本移植学会 The Japan Society for Transplantation |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0578-7947 2188-0034 |
| DOI | 10.11386/jst.50.6_565 |
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| Abstract | 「緒言」2010年7月に15歳未満の小児の臓器提供を可能にした改正臓器移植法が施行された. これにより小児の心臓移植の増加が予想されたが, 2014年12月末時点での15歳未満の脳死臓器提供からの小児心臓移植数は7例と少数にとどまっている. 臓器提供者の不足と2年近くになる長期の移植待機の根本的解決とはなっていないのが実情である. このような背景から小児末期心不全に対してはbreakthroughとなる新しい治療戦略が切望されている. 2011年から岡山大学では自己心臓内幹細胞移植療法の臨床研究を行っており, 第1相臨床研究 (Transcoronary Infusion of Cardiac Progenitor cell infusion in patients with single ventricle physiology : TICAP試験, NCT01273857) により, その安全性と有効性を確認し世界に先駆けて報告した. |
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| AbstractList | 「緒言」2010年7月に15歳未満の小児の臓器提供を可能にした改正臓器移植法が施行された. これにより小児の心臓移植の増加が予想されたが, 2014年12月末時点での15歳未満の脳死臓器提供からの小児心臓移植数は7例と少数にとどまっている. 臓器提供者の不足と2年近くになる長期の移植待機の根本的解決とはなっていないのが実情である. このような背景から小児末期心不全に対してはbreakthroughとなる新しい治療戦略が切望されている. 2011年から岡山大学では自己心臓内幹細胞移植療法の臨床研究を行っており, 第1相臨床研究 (Transcoronary Infusion of Cardiac Progenitor cell infusion in patients with single ventricle physiology : TICAP試験, NCT01273857) により, その安全性と有効性を確認し世界に先駆けて報告した. In July 2010, the domestic law for organ transplants was revised to enable children under 15-year of age to donate their organs if the parents had given consent in the case of brain death. After this revision, the substantial number of pediatric heart transplantations was expected to increase; however only 7 cases were performed during these 5 years. The problems related to the shortage of organ donors and long waiting times for orthotopic heart transplantations have not yet been resolved. As a result, new treatment strategies including innovative mechanical devices and regenerative therapies for pediatric heart failure, are critically needed. Accumulated evidence of cardiac regeneration strategies using various types of somatic stem cells have revealed the efficacy of stem cell therapies for heart failure. Initial results of the Transcoronary Infusion of Cardiac Progenitor cell infusion in patients with single ventricle physiology (TICAP) phase I study (NCT01273857) conducted at Okayama University (2011-2013) have shown that intracoronary infusion of cardiosphere-derived cells (CDCs) following staged palliation was feasible and safe to treat children with hypoplastic left heart syndrome. Currently, a randomized phase II trial (Cardiac Progenitor Cell Infusion to treat Univentricular Heart Disease: PERSEUS, NCT01829750) is ongoing at our institution to verify the therapeutic efficacy of CDC infusion in patients with univentricular heart diseases. From 2016, we will conduct a countrywide sponsor-initiated multicenter clinical trial to construct this therapeutic strategy for children with heart failure as an insurance coverage treatment. In this review, we discuss the problems involved with end-stage pediatric heart failure and the current status of stem cell therapy for heart failure in children. |
| Author | 佐野, 俊二 石神, 修大 王, 英正 |
| Author_FL | OH Hidemasa SANO Shunji ISHIGAMI Shuta |
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| Copyright | 2015 一般社団法人 日本移植学会 |
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| References | 23) Tarui S, Sano S, Oh H. Stem cell therapies in patients with single ventricle physiology. Methodist Debakey Cardiovasc J 2014; 10: 77-81. 28) Rupp S, Jux C, Bönig H, et al. Intracoronary bone marrow cell application for terminal heart failure in children. Cardiol Young 2012; 22: 558-563. 31) Rupp S, Zeiher AM, Dimmeler S, et al. A regenerative strategy for heart failure in hypoplastic left heart syndrome: intracoronary administration of autologous bone marrow-derived progenitor cells. J Heart Lung Transplant 2010; 29: 574-577. 4) Brink JG, Hassoulas J. The first human heart transplant and further advances in cardiac transplantation at Groote Schuur Hospital and the University of Cape Town - with reference to : the operation. A human cardiac transplant : an interim report of a successful operation performed at Groote Schuur Hospital, Cape Town. Cardiovasc J Afr 2009; 20: 31-35. 26) Rivas J, Menéndez JJ, Arrieta R, et al. Usefulness of intracoronary therapy with progenitor cells in patients with dilated cardiomyopathy: Bridge or alternative to heart transplantation? An Pediatr 2011; 74: 218-225. 1) Feinstein JA, Benson DW, Dubin AM, et al. Hypoplastic left heart syndrome: current considerations and expectations. J Am Coll Cardiol 2012; 59: S1-42. 46) 倉田健児, Choi Y-H. 再生医療の普及のあり方―日韓間の規制枠組みの比較を通して―. RIETI Discussion Paper series 10-J-039. 東京: 独立行政法人経済産業研究所. 2010. 10) 日本心臓移植研究会. 心臓移植レジストリ. http://www.jsht.jp/registry/japan 40) Simpson DL, Mishra R, Sharma S, et al. A strong regenerative ability of cardiac stem cells derived from neonatal hearts. Circulation 2012; 126: S46-S53. 2) Rossano JW, Shaddy RE. Heart failure in children: etiology and treatment. J Pediatr 2014; 165: 228-233. 5) Kantrowitz A, Haller JD, Joos H, et al. Transplantation of the heart in an infant and an adult. Am J Cardiol 1968; 22: 782-790. 33) Hierlihy AM, Seale P, Lobe CG, et al. The post-natal heart contains a myocardial stem cell population. FEBS Lett 2002; 530: 239-243. 14) Wehman B, Kaushal S. The emergence of stem cell therapy for patients with congenital heart disease. Circ Res 2015; 116: 566-569. 18) Poss KD, Wilson LG, Keating MT. Heart regeneration in zebrafish. Science 2002; 298: 2188-2190. 22) Moodie DS, Fyfe D, Gill CC, et al. Anomalous origin of the left coronary artery from the pulmonary artery (Bland-White-Garland syndrome) in adult patients: long-term follow-up after surgery. Am Heart J 1983; 106: 381-388. 37) Smith RR, Barile L, Cho HC, et al. Regenerative potential of cardiosphere-derived cells expanded from percutaneous endomyocardial biopsy specimens. Circulation 2007; 115: 896-908. 45) Tarui S, Ishigami S, Ousaka D, et al. Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome: Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single-Ventricle Physiology (TICAP) trial. J Thorac Cardiovasc Surg 2015; 150: 1198-1208.e2. 7) Cooley DA, Frazier OH, Van Buren CT, et al. Cardiac transplantation in an 8-month-old female infant with subendocardial fibroelastosis. JAMA 1986; 256: 1326-1329. 30) Olguntürk R, Kula S, Sucak GT, et al. Peripheric stem cell transplantation in children with dilated cardiomyopathy: preliminary report of first two cases. Pediatr Transplant 2010; 14: 257-260. 8) Bailey L, Concepcion W, Shattuck H, et al. Method of heart transplantation for treatment of hypoplastic left heart syndrome. J Thorac Cardiovasc Surg 1986; 92: 1-5. 25) Bergmane I, Lacis A, Lubaua I, et al. Follow-up of the patients after stem cell transplantation for pediatric dilated cardiomyopathy. Pediatr Transplant 2013; 17: 266-270. 16) de Jong R, Houtgraaf JH, Samiei S, et al. Intracoronary stem cell infusion after acute myocardial infarction: a meta-analysis and update on clinical trials. Circ Cardiovasc Interv 2014; 7: 156-167. 39) Mishra R, Vijayan K, Colletti EJ, et al. Characterization and functionality of cardiac progenitor cells in congenital heart patients. Circulation 2011; 123: 364-373. 27) Lacis A, Erglis A. Intramyocardial administration of autologous bone marrow mononuclear cells in a critically ill child with dilated cardiomyopathy. Cardiol Young 2011; 21: 110-112. 9) Dipchand AI, Kirk R, Edwards LB, et al. The Registry of the International Society for Heart and Lung Transplantation: Sixteenth Official Pediatric Heart Transplantation Report--2013; focus theme: age. J Heart Lung Transplant 2013; 32: 979-988. 15) Jeevanantham V, Butler M, Saad A, et al. 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. 34) Beltrami AP, Barlucchi L, Torella D, et al. Adult cardiac stem cells are multipotent and support myocardial regeneration. Cell 2003; 114: 763-776. 42) 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. 29) Rupp S, Bauer J, Tonn T, et al. Intracoronary administration of autologous bone marrow-derived progenitor cells in a critically ill two-yr-old child with dilated cardiomyopathy. Pediatr Transplant 2009; 13: 620-623. 24) Limsuwan A, Pienvichit P, Limpijankit T, et al. Transcoronary bone marrow-derived progenitor cells in a child with myocardial infarction: first pediatric experience. Clin Cardiol 2010; 33: E7-E12. 41) Li TS, Cheng K, Malliaras K, et al. Direct comparison of different stem cell types and subpopulations reveals superior paracrine potency and myocardial repair efficacy with cardiosphere-derived cells. J Am Coll Cardiol 2012; 59: 942-953. 38) Tateishi K, Ashihara E, Honsho S, et al. Human cardiac stem cells exhibit mesenchymal features and are maintained through Akt/GSK-3beta signaling. Biochem Biophys Res Commun 2007; 352: 635-641. 11) 日本臓器移植ネットワーク. 移植に関するデータ. http://www.jotnw.or.jp/datafile/index.html 3) Kantor PF, Lougheed J, Dancea A, et al. Presentation, diagnosis, and medical management of heart failure in children: Canadian Cardiovascular Society guidelines. Can J Cardiol 2013; 29: 1535-1552. 19) Porrello ER, Mahmoud AI, Simpson E, et al. Transient regenerative potential of the neonatal mouse heart. Science 2011; 331: 1078-1080. 20) Rupp S, Schranz D. Cardiac Regeneration in Children. Pediatr Cardiol 2015; 36: 713-718. 13) Menasché P, Hagege AA, Scorsin M, et al. Myoblast transplantation for heart failure. Lancet 2001; 357: 279-280. 36) Messina E, De Angelis L, Frati G, et al. Isolation and expansion of adult cardiac stem cells from human and murine heart. Circ Res 2004; 95: 911-921. 47) 平成24年中小企業支援調査（再生医療の周辺産業に関する調査）報告書. 東京: シード・プランニング, 2013. 6) Schweiger M, Stiasny B, Dave H, et al. Pediatric heart transplantation. J Thorac Dis 2015; 7: 552-559. 32) Burkhart HM, Qureshi MY, Peral SC, et al. Regenerative therapy for hypoplastic left heart syndrome: first report of intraoperative intramyocardial injection of autologous umbilical-cord blood-derived cells. J Thorac Cardiovasc Surg 2015; 149: e35-e37. 35) Oh H, Bradfute SB, Gallardo TD, et al. Cardiac progenitor cells from adult myocardium: homing, differentiation, and fusion after infarction. Proc Natl Acad Sci U S A 2003; 100: 12313-12318. 12) Nakatani T, Fukushima N, Ono M, et al. The registry report of heart transplantation in Japan (1999-2013). Circ J 2014; 78: 2604-2609. 21) Mongé MC, Eltayeb O, Costello JM, et al. Aortic implantation of anomalous origin of the left coronary artery from the pulmonary artery: long-term outcomes. Ann Thorac Surg 2015; 100: 154-160. 44) Ishigami S, Ohtsuki S, Tarui S, et al. Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial. Circ Res 2015; 116: 653-664. 43) Makkar RR, Smith RR, Cheng K, et al. Intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction (CADUCEUS) : a prospective, randomised phase 1 trial. Lancet 2012; 379: 895-904. 17) Ishigami S, Sano S, Oh H. Cardiac stem cell therapies for congenital heart diseases. Stem Cell Transl Invest 2015; 2: e800. |
| References_xml | – reference: 4) Brink JG, Hassoulas J. The first human heart transplant and further advances in cardiac transplantation at Groote Schuur Hospital and the University of Cape Town - with reference to : the operation. A human cardiac transplant : an interim report of a successful operation performed at Groote Schuur Hospital, Cape Town. Cardiovasc J Afr 2009; 20: 31-35. – reference: 18) Poss KD, Wilson LG, Keating MT. Heart regeneration in zebrafish. Science 2002; 298: 2188-2190. – reference: 31) Rupp S, Zeiher AM, Dimmeler S, et al. A regenerative strategy for heart failure in hypoplastic left heart syndrome: intracoronary administration of autologous bone marrow-derived progenitor cells. J Heart Lung Transplant 2010; 29: 574-577. – reference: 33) Hierlihy AM, Seale P, Lobe CG, et al. The post-natal heart contains a myocardial stem cell population. FEBS Lett 2002; 530: 239-243. – reference: 1) Feinstein JA, Benson DW, Dubin AM, et al. Hypoplastic left heart syndrome: current considerations and expectations. J Am Coll Cardiol 2012; 59: S1-42. – reference: 8) Bailey L, Concepcion W, Shattuck H, et al. Method of heart transplantation for treatment of hypoplastic left heart syndrome. J Thorac Cardiovasc Surg 1986; 92: 1-5. – reference: 22) Moodie DS, Fyfe D, Gill CC, et al. Anomalous origin of the left coronary artery from the pulmonary artery (Bland-White-Garland syndrome) in adult patients: long-term follow-up after surgery. Am Heart J 1983; 106: 381-388. – reference: 32) Burkhart HM, Qureshi MY, Peral SC, et al. Regenerative therapy for hypoplastic left heart syndrome: first report of intraoperative intramyocardial injection of autologous umbilical-cord blood-derived cells. J Thorac Cardiovasc Surg 2015; 149: e35-e37. – reference: 40) Simpson DL, Mishra R, Sharma S, et al. A strong regenerative ability of cardiac stem cells derived from neonatal hearts. Circulation 2012; 126: S46-S53. – reference: 3) Kantor PF, Lougheed J, Dancea A, et al. Presentation, diagnosis, and medical management of heart failure in children: Canadian Cardiovascular Society guidelines. Can J Cardiol 2013; 29: 1535-1552. – reference: 36) Messina E, De Angelis L, Frati G, et al. Isolation and expansion of adult cardiac stem cells from human and murine heart. Circ Res 2004; 95: 911-921. – reference: 30) Olguntürk R, Kula S, Sucak GT, et al. Peripheric stem cell transplantation in children with dilated cardiomyopathy: preliminary report of first two cases. Pediatr Transplant 2010; 14: 257-260. – reference: 13) Menasché P, Hagege AA, Scorsin M, et al. Myoblast transplantation for heart failure. Lancet 2001; 357: 279-280. – reference: 23) Tarui S, Sano S, Oh H. Stem cell therapies in patients with single ventricle physiology. Methodist Debakey Cardiovasc J 2014; 10: 77-81. – reference: 9) Dipchand AI, Kirk R, Edwards LB, et al. The Registry of the International Society for Heart and Lung Transplantation: Sixteenth Official Pediatric Heart Transplantation Report--2013; focus theme: age. J Heart Lung Transplant 2013; 32: 979-988. – reference: 37) Smith RR, Barile L, Cho HC, et al. Regenerative potential of cardiosphere-derived cells expanded from percutaneous endomyocardial biopsy specimens. Circulation 2007; 115: 896-908. – reference: 7) Cooley DA, Frazier OH, Van Buren CT, et al. Cardiac transplantation in an 8-month-old female infant with subendocardial fibroelastosis. JAMA 1986; 256: 1326-1329. – reference: 24) Limsuwan A, Pienvichit P, Limpijankit T, et al. Transcoronary bone marrow-derived progenitor cells in a child with myocardial infarction: first pediatric experience. Clin Cardiol 2010; 33: E7-E12. – reference: 45) Tarui S, Ishigami S, Ousaka D, et al. Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome: Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single-Ventricle Physiology (TICAP) trial. J Thorac Cardiovasc Surg 2015; 150: 1198-1208.e2. – reference: 46) 倉田健児, Choi Y-H. 再生医療の普及のあり方―日韓間の規制枠組みの比較を通して―. RIETI Discussion Paper series 10-J-039. 東京: 独立行政法人経済産業研究所. 2010. – reference: 6) Schweiger M, Stiasny B, Dave H, et al. Pediatric heart transplantation. J Thorac Dis 2015; 7: 552-559. – reference: 34) Beltrami AP, Barlucchi L, Torella D, et al. Adult cardiac stem cells are multipotent and support myocardial regeneration. Cell 2003; 114: 763-776. – reference: 35) Oh H, Bradfute SB, Gallardo TD, et al. Cardiac progenitor cells from adult myocardium: homing, differentiation, and fusion after infarction. Proc Natl Acad Sci U S A 2003; 100: 12313-12318. – reference: 12) Nakatani T, Fukushima N, Ono M, et al. The registry report of heart transplantation in Japan (1999-2013). Circ J 2014; 78: 2604-2609. – reference: 14) Wehman B, Kaushal S. The emergence of stem cell therapy for patients with congenital heart disease. Circ Res 2015; 116: 566-569. – reference: 25) Bergmane I, Lacis A, Lubaua I, et al. Follow-up of the patients after stem cell transplantation for pediatric dilated cardiomyopathy. Pediatr Transplant 2013; 17: 266-270. – reference: 5) Kantrowitz A, Haller JD, Joos H, et al. Transplantation of the heart in an infant and an adult. Am J Cardiol 1968; 22: 782-790. – reference: 16) de Jong R, Houtgraaf JH, Samiei S, et al. Intracoronary stem cell infusion after acute myocardial infarction: a meta-analysis and update on clinical trials. Circ Cardiovasc Interv 2014; 7: 156-167. – reference: 20) Rupp S, Schranz D. Cardiac Regeneration in Children. Pediatr Cardiol 2015; 36: 713-718. – reference: 2) Rossano JW, Shaddy RE. Heart failure in children: etiology and treatment. J Pediatr 2014; 165: 228-233. – reference: 39) Mishra R, Vijayan K, Colletti EJ, et al. Characterization and functionality of cardiac progenitor cells in congenital heart patients. Circulation 2011; 123: 364-373. – reference: 43) Makkar RR, Smith RR, Cheng K, et al. Intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction (CADUCEUS) : a prospective, randomised phase 1 trial. Lancet 2012; 379: 895-904. – reference: 42) 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. – reference: 44) Ishigami S, Ohtsuki S, Tarui S, et al. Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial. Circ Res 2015; 116: 653-664. – reference: 47) 平成24年中小企業支援調査（再生医療の周辺産業に関する調査）報告書. 東京: シード・プランニング, 2013. – reference: 27) Lacis A, Erglis A. Intramyocardial administration of autologous bone marrow mononuclear cells in a critically ill child with dilated cardiomyopathy. Cardiol Young 2011; 21: 110-112. – reference: 28) Rupp S, Jux C, Bönig H, et al. Intracoronary bone marrow cell application for terminal heart failure in children. Cardiol Young 2012; 22: 558-563. – reference: 15) Jeevanantham V, Butler M, Saad A, et al. 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. – reference: 17) Ishigami S, Sano S, Oh H. Cardiac stem cell therapies for congenital heart diseases. Stem Cell Transl Invest 2015; 2: e800. – reference: 10) 日本心臓移植研究会. 心臓移植レジストリ. http://www.jsht.jp/registry/japan/ – reference: 26) Rivas J, Menéndez JJ, Arrieta R, et al. Usefulness of intracoronary therapy with progenitor cells in patients with dilated cardiomyopathy: Bridge or alternative to heart transplantation? An Pediatr 2011; 74: 218-225. – reference: 38) Tateishi K, Ashihara E, Honsho S, et al. Human cardiac stem cells exhibit mesenchymal features and are maintained through Akt/GSK-3beta signaling. Biochem Biophys Res Commun 2007; 352: 635-641. – reference: 19) Porrello ER, Mahmoud AI, Simpson E, et al. Transient regenerative potential of the neonatal mouse heart. Science 2011; 331: 1078-1080. – reference: 41) Li TS, Cheng K, Malliaras K, et al. Direct comparison of different stem cell types and subpopulations reveals superior paracrine potency and myocardial repair efficacy with cardiosphere-derived cells. J Am Coll Cardiol 2012; 59: 942-953. – reference: 11) 日本臓器移植ネットワーク. 移植に関するデータ. http://www.jotnw.or.jp/datafile/index.html – reference: 21) Mongé MC, Eltayeb O, Costello JM, et al. Aortic implantation of anomalous origin of the left coronary artery from the pulmonary artery: long-term outcomes. Ann Thorac Surg 2015; 100: 154-160. – reference: 29) Rupp S, Bauer J, Tonn T, et al. 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| Snippet | 「緒言」2010年7月に15歳未満の小児の臓器提供を可能にした改正臓器移植法が施行された. これにより小児の心臓移植の増加が予想されたが, 2014年12月末時点での15歳未満の脳死臓器提供からの小児心臓移植数は7例と少数にとどまっている.... In July 2010, the domestic law for organ transplants was revised to enable children under 15-year of age to donate their organs if the parents had given... |
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| StartPage | 565 |
| SubjectTerms | cardiac regeneration cardiac stem cell therapy heart transplantation pediatric heart failure |
| Title | 小児心不全に対する再生医療からのアプローチ |
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