( 報告様式 4) 16ek h0001 平成 29 年 5 月 31 日 平成 28 年度委託研究開発成果報告書 I. 基本情報 事 業 名 : ( 日本語 ) 免疫アレルギー疾患等実用化研究事業 ( 移植医療技術開発研究分野 ) ( 英語 )Practical Research Pr
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1 ( 報告様式 4) 16ek h0001 平成 29 年 5 月 31 日 平成 28 年度委託研究開発成果報告書 I. 基本情報 事 業 名 : ( 日本語 ) 免疫アレルギー疾患等実用化研究事業 ( 移植医療技術開発研究分野 ) ( 英語 )Practical Research Project for Allergic Diseases and Immunology (Research on Technology of Medical Transplantation) 研究開発課題名 : ( 日本語 ) 本邦における同種造血幹細胞移植の最適化を目指した移植医療体制の確立と国際的視点からの Harmonization に関する研究 ( 英語 )Optimization of hematopoietic stem cell transplantation system in Japan under the perspective of global harmonization 研究開発担当者 ( 日本語 ) 慶應義塾大学医学部内科学 ( 血液 ) 教室教授岡本真一郎所属役職氏名 : ( 英語 ) Shinichiro Okamoto, Professor of Medicine (Hematology), Department of Medicine, Keio University School of Medicine 実施期間 : 平成 28 年 4 月 1 日 ~ 平成 29 年 3 月 31 日 ( 日本語 ) 移植を受ける患者選択の最適化 ( 英語 )Optimizing patient selection for HSCT 研究開発分担者 ( 日本語 ) 国立がん研究センター中央病院 造血幹細胞移植科科長福田隆浩所属役職氏名 :( 英語 )Takahiro Fukuda, Chief, Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital 研究開発分担者 ( 日本語 ) 一般社団法人日本造血細胞移植データセンター センター長 熱田由子所属役職氏名 : ( 英語 )Yoshiko Atsuta, Scientific Director, The Japanese Data Center for Hematopoietic Cell Transplantation ( 日本語 ) 非血縁者ドナーからの造血幹細胞提供の最適化 ( 英語 )Optimizing stem cell donation from unrelated donors 1
2 研究開発分担者 ( 日本語 ) 国立がん研究センター東病院医長瀬尾幸子 所属役職氏名 : ( 英語 )Sachiko Seo, Chief, National Cancer Hospital East 研究開発分担者 ( 日本語 ) 一般社団法人日本造血細胞移植データセンター センター長 熱田由子所属役職氏名 :( 英語 )Yoshiko Atsuta, Scientific Director, The Japanese Data Center for Hematopoietic Cell Transplantation ( 日本語 ) 骨髄バンクおよび臍帯血バンクの最適なドナープールサイズの最適化 ( 英語 )Optimizing the size of bone marrow donor registry and cord blood Bank 研究開発分担者 ( 日本語 ) 京都大学大学院医学研究科 血液 腫瘍内科学 病院特定助教 諌田淳也所属役職氏名 :( 英語 )Junya Kanda, Program-Specific Assistant Professor, Department of Hematology and Oncology, Graduate School of Medicine, Kyoto University 研究開発分担者 ( 日本語 ) 慶應義塾大学医学部内科学 ( 血液 ) 教室准教授森毅彦所属役職氏名 : ( 英語 ) Takehiko Mori, Associate Professor of Medicine, Division of Hematology, Department of Medicine, School of Medicine, Keio University ( 日本語 ) 造血幹細胞移植体制の最適化 ( 英語 )Optimizing the system supporting hematopoietic stem cell transplantation 研究開発分担者 ( 日本語 ) 東京大学医科学研究所分子療法分野准教授高橋聡所属役職氏名 :( 英語 )Satoshi Takahashi, Associate Professor, Division of Molecular Therapy, Institute of Medical Science, University of Tokyo 研究開発分担者 ( 日本語 ) 愛知医科大学医学部造血細胞移植振興寄附講座講師飯田美奈子所属役職氏名 : ( 英語 ) Minako Iida, Lecturer, Department of Promotion for Blood and Marrow Transplantation, School of Medicine, Aichi Medical University 2
3 II. 成果の概要 ( 総括研究報告 ) 研究開発代表者による報告の場合 本研究は 高齢化 少子化 医療費の高騰等の進む医療環境の中で 多くの血液疾患の根治療法として施行されている同種造血幹細胞移植の最適化をめざして 移植患者 ドナー そして移植医療体制の視点から 実際のガイドラインや政策提言などに繋がる検討を行うことを目標としている 以下今年度の進捗状況を報告する 移植を受ける患者選択の最適化に関しては 2007 年から 2011 年までに初回同種造血幹細胞移植を施行した症例のうち 臍帯血移植 ハプロ移植症例やデータ欠損例を除いた 4111 例の移植症例のデータベースを作成した このデータベースを learning cohort と validation cohort に分け 主要アウトカムを 2 年全生存率とした多変量解析を用いて危険因子を抽出し 移植時の年齢 ドナー 幹細胞ソース PS 疾患リスク HCT-CI による予後予測の新規スコアリングシステムを作成した 次にシステムの再現性を validation cohort を用いて確認した これまで用いられてきた HCT-CI 単独の評価と比較して このスコアリングシステムによる患者の層別化は より全生存率の予測力が優れており 移植選択の際に参考となるものと考えられる このスコアリングシステムに生活の質を客観的に反映させることを目指して 同様のデータベースを用いて 移植後 2 年の時点での GVHD-free, Relapse-free survival(grfs) を主要アウトカムとし多解析を進め より現状の移植に適したスコアリングシステムの構築を目指している ( 共同研究者 : 藤重夫 中村文明 ) EBMT のデータベースを用いた我々のスコアリングシステムの validation の準備も進められている 分担研究者の福田 熱田を中心として AML に対する臍帯血移植の両レジストリー間での成績比較の臨床研究が EBMT で承認され データ共有に関する具体的な検討が開始されたので これと並行してデータ共有を具体的に進めていく予定である 造血幹細胞を提供する非血縁者ドナーの最適化に関しては 分担研究者の瀬尾を中心として 骨髄バンクドナー選択の最適化とそのドナープールサイズの両面から検討を加えた バンクドナー選択の最適化に関しては 日本造血細胞移植データセンターから移植患者およびドナーのデータベースを作成した このデータベースを用いて非血縁ドナーの年齢が移植成績の及ぼす影響に関して解析を行った その結果 高齢ドナーによる移植では GVHDが増加することにより 移植関連死亡が増加して 移植成績が低下することが明らかとなり 若年ドナーリクルートをさらに促進する基盤となる結果を得た 今後は ドナーリクルートの視点から見て重要な体重差および性別に関しての解析 若年非血縁ドナーと高齢血縁ドナーの移植成績の比較の解析をする予定である 骨髄バンクおよび臍帯血バンクのドナープールサイズの最適化に関しては 分担研究者の諌田 森 研究協力者の西脇を中心として 多様化する造血細胞ソースを包括的に評価することで現在のドナープールサイズが適正かを明らかにし 具体的な政策提言に繋がる結果を目指して 骨髄バンクと臍帯血バンクの両視点から検討を加えることとした 骨髄バンクに関しては 患者 HLA 情報を用いてハプロタイプを算定し 移植を必要とする患者数 HLA 適合率を変数として 最低 1 名の適合ドナーが見いだすことが出来るバンクサイズを算出する流動的なプログラムを作成する計画を立て 倫理委員会の承認を得てデータを取得し 現在解析を進めている 臍帯血に関しては 我が国における人口動態 移植適応患者の推移 非血縁者間のHLA 適合率と実際の提供率 出生率と臍帯血提供率などを基にした中長期的な骨髄および臍帯血バンクの至適ドナー ( ユニット ) 数を明らかにするための解析を計画し 倫理委員会の承認を得て 骨髄バンクのデータベースを用いて模擬患者集団の抽出を行っている 造血幹細胞移植体制の最適化に関しては 分担研究者高橋 飯田を中心として アジア諸国における 3
4 移植施設に関する認定基準を米国や欧州の認定基準との harmonization を図りながら策定することを目指している 今年度は米国の移植施設認定機関 (FACT) と 我々が英訳した日本造血細胞移植学会移植施設認定基準および日本骨髄バンク採取施設認定基準を共有し 両国間での施設認定に関する基本的な考え方について意見交換を行っている 今年度は FACT が revise されたので 改定項目に関する確認に時間を要しているが 基本的には ほぼ予定通りに進行している WBMT/Asia 諸国における移植施設基準策定に関しては 策定のための情報収集を継続している 具体的には Asia-Pacific Blood and Marrow Transplantation Group(APBMT) 参加各国の認定の状況に関する情報収集を 隔月で開催される Registry Committee の Web conference を中心に収集している この情報を基に WBMT の移植施設が備えるべき体制 人材などに関する recommendation を基盤として 予定通りアジア諸国における移植施設認定基準とその運用方法についての議論を開始する予定である The aim of this study is to explore the ways of optimizing allogeneic hematopoietic cell transplantation (HCT) which has been widely performed in Japan as the treatment of a variety of hematological diseases. Aging of Japanese society is resulting in rapid and steady increase of older transplant patients who require more human and social resources for their care compared with younger patients. Aging of donors would also result in the shortage of stem cell sources in the very near future. Thus, in order to use our limited resources wisely, optimization of current approaches in allogeneic HCT is eagerly needed. This study will address the optimization from the perspective of patient, donor/stem cells, and systems supporting HCT. Regarding optimization in indications of allogeneic HCT, we analyzed the transplant outcome data of 4,111 patients registered at JDCHCT data base, and constructed the scoring system based upon recipient age, stem cells, PS, disease risk, and HCT-CI score. The system could predict which patient is more likely or unlikely to benefit from allo-hct than the already existed scoring system. We are now preparing the validation of our scoring system by using European HCT data base (EBMT registry), and refine the system with GVHD-free, relapse-free survival (GFRS) as the outcome including QOL, the most important endpoint for older patients. Regarding optimization in stem cell donor, our approaches included the selection of optimal donor and size of donor/stem cell banks. Our study clearly demonstrated that the use of older unrelated donors were associated with lower overall survival by increasing GVHD after HCT compared with younger donors, emphasizing the importance of recruiting well motivated younger donors. We are currently planning additional analysis to find out the donor profiles that predict better transplant outcome. To estimate the optimal size of donor bank and cord blood bank are also crucial issues. To address this issue, we are constructing a fluid model estimating optimal size of donor/stem cell banks based upon the frequency of HLA haplotype in Japanese, population dynamics, trajectory changes in transplant number, current HLA matching rate, birth rate, and the donation rate of cord blood. To ensure the quality of transplant facilities is also important to optimize the utilization of our resource including stem cells. Global harmonization should also be taken into account in this issue. We have prepared the English version of Japanese accreditation documents for being transplant as well as collection centers and started discussing with FACT/JACIE regarding global harmonization. In addition, we are now collecting information regarding the current status of accreditation for transplant facility in Asia-Pacific area in order to set for setting the accreditation guideline of the transplant facilities in this region. 4
5 III. 成果の外部への発表 (1) 学会誌 雑誌等における論文一覧 ( 国内誌 0 件 国際誌 8 件 ) 1. Mohty M, Malard F, Abecassis M, Aerts E, Alaskar AS, Aljurf M, Arat M, Bader P, Baron F, Bazarbachi A, Blaise D, Ciceri F, Corbacioglu S, Dalle JH, Dignan F, Fukuda T, Huynh A, Masszi T, Michallet M, Nagler A, NiChonghaile M, Okamoto S, Pagliuca A, Peters C, Petersen FB, Richardson PG, Ruutu T, Savani BN, Wallhult E, Yakoub-Agha I, Duarte RF, Carreras E. Revised diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in adult patients: a new classification from the European Society for Blood and Marrow Transplantation. Bone Marrow Transplant Jul;51(7): Atsuta Y, Hirakawa A, Nakasone H, Kurosawa S, Oshima K, Sakai R, Ohashi K, Takahashi S, Mori T, Ozawa Y, Fukuda T, Kanamori H, Morishima Y, Kato K, Yabe H, Sakamaki H, Taniguchi S, Yamashita T; Late Effect and Quality of Life Working Group of the Japan Society for Hematopoietic Cell Transplantation. Late Mortality and Causes of Death among Long-Term Survivors after Allogeneic Stem Cell Transplantation. Biol Blood Marrow Transplant (9) Kanda J, Ikegame K, Fuji S, Kurokawa M, Kanamori H, Fukuda T, Ohashi K, Ishikawa J, Ogawa H, Inoue M, Ichinohe T, Atsuta Y, Kanda Y; HLA Working Group of the Japan Society for Hematopoietic Cell Transplantation. Haploidentical and Matched-Sibling Donor Hematopoietic Cell Transplantation for Patients with HLA-Homozygous Haplotypes. Biol Blood Marrow Transplant (11) Inamoto Y, Kimura F, Kanda J, Sugita J, Ikegame K, Nakasone H, Nannya Y, Uchida N, Fukuda T, Yoshioka K, Ozawa Y, Kawano I, Atsuta Y, Kato K, Ichinohe T, Inoue M, Teshima T. Comparison of graft-versus-host disease-free, relapse-free survival according to a variety of graft sources: antithymocyte globulin and single cord blood provide favorable outcomes in some subgroups. Haematologica (12) Yokoyama H, Kanda J, Fuji S, Kim SW, Fukuda T, Najima Y, Ohno H, Uchida N, Ueda Y, Eto T, Iwato K, Kobayashi H, Ozawa Y, Kondo T, Ichinohe T, Atsuta Y, Kanda Y; HLA Working Group of the Japan Society for Hematopoietic Cell Transplantation. Impact of Human Leukocyte Antigen Allele Mismatch in Unrelated Bone Marrow Transplantation with Reduced-Intensity Conditioning Regimen. Biol Blood Marrow Transplant (2) D Niederwieser, H Baldomero, J Szer, M Gratwohl, M Aljurf, Y Atsuta, L F Bouzas, D Confer,H Greinix, M Horowitz, M Iida, J Lipton, M Mohty, N Novitzky, J Nunez, J Passweg,M C Pasquini, Y Kodera, J Apperley, A Seber and A Gratwohl for the Worldwide Network of Blood and Marrow Transplantation (WBMT). Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. Bone Marrow Transplantation (2016) 51, ; doi: /bmt ; published online 22 February
6 7. Kurosawa S, Yamaguchi H, Yamaguchi T, Fukunaga K, Yui S, Wakita S, Kanamori H, Usuki K, Uoshima N, Yanada M, Shono K, Ueki T, Mizuno I, Yano S, Takeuchi J, Kanda J, Okamura H, Inamoto Y, Inokuchi K, Fukuda T. Decision analysis of post-remission therapy in cytogenetically intermediate-risk AML: The impact of FLT3-ITD, NPM1, and CEBPA. Biol Blood Marrow Transplant Jun;22(6): Kanda J, Morishima Y, Terakura S, et al. Impact of graft-versus-host disease on outcomes after unrelated cord blood transplantation. Leukemia Mar;31(3): (2) 学会 シンポジウム等における口頭 ポスター発表 1. Okamoto S, Challenges in hematopoietic stem cell transplantation in Joint session EBMT/Japan/China 口頭 The 42nd Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) April 6 /2016, Valencia, Spain 国外 2. Okamoto S, Design the Future of hematopoietic stem cell transplantation: APBMT perspectives in an ASBMT/EBMT/APBMT Joint Plenary Session 口頭 The 21 Annual Congress of Asia- Pacific Blood and Marrow Transplantation Group (APBMT) October28/2016 Singapore 国外 Late mortality and causes of death among long survivors after autologous stem cell transplantation. ポスター Minako Iida, Hideki Nakasone, Yoshihiro Inamoto, Masami Inoue, Yasushi Ishida, Hitoji Uchiyama, Kouji Iwato, Toshihiro Miyamoto, Hisako Hashimoto, Takehiko Mori, Masashi Sawa, Yujyu Ohno, Kaoru Kahata, Takahiro Fukuda, Makoto Hirokawa, Takuya Yamashita, Yoshiko Atsuta, for the Late Effect and Quality of Life Working Group of the Japan Society for Hematopoietic Cell Transplantation APBMT Annual Congress 2016, 2016 Oct 28~30, 海外 4. Clinical impact of HLA disparity and anti-hla antibody in cord blood transplants Satoshi Takahashi 2016 European Society for Blood and Marrow Transplantation (EBMT) Meeting. (Valencia, Spain. 4 April 2016) 国外 5. Clinical impact of HLA disparity and anti-hla antibody in cord blood transplants Satoshi Takahashi The 4th International CBT Summit and the National CME of the Advance of Unrelated CBT (June 24-26, 2016 at Hefei, China) 国外 6. Impact of graft-versus-host disease on outcomes after pediatric single cord blood transplantation: A retrospective analysis from the JSHCT GVHD Working Group, Oral session, Kanda J, Umeda K, Kato K, et al. 43 rd Annual Meeting of the EBMT, 2016/3/28, 国外 (3) 国民との科学 技術対話社会 に対する取り組み該当なし (4) 特許出願該当なし 6
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