ｉＰＳ細胞移植 再生医療普及への試金石だ

The Yomiuri Shimbun
Clinical trial using iPS cells litmus test for promoting regenerative medicine
ｉＰＳ細胞移植　再生医療普及への試金石だ

The latest clinical trial is the first step of epoch-making research that could evolve into regenerative medicine. After careful safety assessment, putting the latest result into practical use should be promoted.
　画期的な研究成果を再生医療に発展させる第一歩である。安全性を慎重に評価し、患者への実用化を進めたい。

A team led by RIKEN ophthalmologist Masayo Takahashi transplanted retina cells produced from induced pluripotent stem (iPS) cells into the eyes of a woman suffering from age-related macular degeneration. The patient is said to be doing well.
　理化学研究所の高橋政代・プロジェクトリーダーらが、ｉＰＳ細胞（人工多能性幹細胞）から網膜の細胞を作製し、目の難病である加齢黄斑変性の患者に移植する手術を行った。術後の経過は順調だという。

It was the world’s first clinical trial of transplanting iPS cells, which can develop into the cells of various types of tissues, into a human body.
　様々な組織の細胞に変化するｉＰＳ細胞を人間の体に移植し、治療に使う世界初の試みだ。

This clinical trial can be considered a litmus test for regenerative medicine using iPS cells, which could eventually be used widely.
ｉＰＳ細胞による再生医療の普及に向けた試金石とも言えよう。

About 700,000 people are estimated to be suffering from the age-related macular degeneration, the symptoms of which include distorted vision.
　視界がゆがむ加齢黄斑変性の国内の患者は、約７０万人に上る。

The current treatment is symptomatic therapy to prevent the patient’s condition from further deteriorating. With the transplant of retina cells, the patient could make a full recovery. Expectations among patients over the effectiveness of such a transplant are believed to be running high.
現在の治療は、症状の悪化を止める対症療法だが、網膜細胞の移植手術なら完治できる可能性がある。患者の期待は大きいだろう。

Over the past seven years, since Prof. Shinya Yamanaka of Kyoto University successfully produced human iPS cells, the risk of the iPS cells becoming cancerous — a key issue to be tackled — has almost been resolved, while the efficiency of production has been enhanced.
　山中伸弥・京都大教授が、人のｉＰＳ細胞の作製に成功してから７年、課題とされた細胞のがん化のリスクはほぼ解消され、作製効率も向上した。

The latest surgical procedure carries important implications as a clinical study to confirm the safety of medical technology using iPS cells. Is there an absolute guarantee the iPS cells will not turn cancerous? Are there any unknown risks? These issues will be examined over the next four years.
　今回の手術は、技術の安全性を確かめる臨床研究として重要な意味を持つ。ｉＰＳ細胞から作った網膜細胞は本当にがん化しないのか、未知のリスクはないのか。４年間にわたり検査を続ける。

In an effort to have research results using iPS cells linked to regenerative medicine, the Education, Culture, Sports, Science and Technology Ministry plans to spend ¥110 billion from fiscal 2012 to 2022.
　文部科学省はｉＰＳ細胞の研究成果を再生医療につなげるため、２０１２～２２年度に計１１００億円を投じる方針だ。

Faster approval needed

Clinical research using iPS cells in the treatment of Parkinson’s disease and serious cardiac failure are planned from next fiscal year.
　来年度以降には、ｉＰＳ細胞を使ったパーキンソン病や重症心不全の治療の臨床研究が計画されている。

Also under way is research to determine the mechanisms behind intractable diseases and develop new medicines for such diseases by producing iPS cells from patients with incurable diseases and transforming them into nerve and muscle cells.
難病患者からｉＰＳ細胞を作って神経や筋肉の細胞に変化させ、病気のメカニズムの解明や、創薬につなげる研究も進む。

It is hoped that with the successful retina cell operation, the transition from basic research to clinical research in regenerative medicine — in which Japan tends to lag behind other major countries — will advance smoothly.
　今回の手術を契機に、日本では滞りがちな基礎研究から臨床研究への移行を円滑に進めたい。

Following the enforcement of the revised Pharmaceutical Affairs Law in November, the time needed to put cells and tissues for regenerative medicine into a practical use will be shortened from the current six years to about three years. If the safety of only a few trials is confirmed and their effectiveness deemed reliable, the ministry will give the go-ahead for practical use, although with conditions attached.
　１１月の改正薬事法施行後は、約６年かかっている再生医療用の細胞・組織の実用化が、３年程度に短縮される。治験数が少なくても安全性が確認でき、有効性が推定できれば条件付きで承認する。

Takahashi has established her own venture firm for producing retina cells derived from iPS cells. Her firm plans to start clinical trials in 2016, with the aim of winning the ministry’s approval in 2018.
　高橋氏はｉＰＳ細胞由来の網膜細胞を製造するベンチャー企業を設立している。１６年に治験を始め、１８年の承認取得が目標だ。

A faster approval system must function effectively so patients can receive treatment as quickly as possible.
患者が一日でも早く治療を受けられるよう、迅速な承認制度を有効に機能させることが求められる。

The RIKEN Center for Developmental Biology, where the clinical trial was conducted, is scheduled to undergo a drastic shakeup. This will include halving the number of research labs due to fraudulent research articles over the so-called stimulus-triggered acquisition pluripotency (STAP) cells.
　臨床研究の舞台である理研の発生・再生科学総合研究センターは、ＳＴＡＰ細胞論文不正により、研究室の半減など解体的な出直しが決まっている。

We hope RIKEN proceeds with its research on regenerative medicine steadily and makes an effort to regain public trust.
再生医療の研究をしっかりと進め、信頼回復に努めてもらいたい。

(From The Yomiuri Shimbun, Sept. 15, 2014)Speech