First Clinical Trial of Heart Disease Treatment Using iPS Cells Conducted: Transplantation via Catheter

Recently NHK News on-line reported the following:

The catheter system used (Source: NHK)

iPS細胞使う心臓病治療の治験1例目を実施 カテーテルで移植

2026年6月12日18:19

iPS細胞

iPS細胞から作った心臓の細胞をカテーテルを使って心臓病の患者に移植する治験の1例目を行ったと、慶応大学発のベンチャー企業などが発表しました。胸を開く手術を行う必要がなく、企業は患者の負担の少ない治療につながるとしています。

これは、慶応大学発の医療ベンチャー企業と、信州大学医学部附属病院の小林秀樹助教らが12日、会見を開いて発表しました。

企業はiPS細胞から心臓の筋肉の細胞を作り球状に加工したうえで、重い心臓病の患者の足の付け根の血管から心臓までカテーテルを通して移植する新たな治療法の開発を進めています。

ことし3月、治験の1例目として「拡張型心筋症」という重い心臓病の70代の男性患者に移植を行い、これまでのところ重い合併症はなく、術後1か月の時点で心臓の機能に改善傾向が見られたということです。

企業は今後、3年間かけて合わせて14人に移植を行い、安全性や有効性を確認するということです。

ことし国に承認されたiPS細胞を使った別の心臓病の治療は胸を開く手術が必要で、企業は今回の方法は患者の負担の少ない治療につながるとしています。

小林助教は「心臓の機能の数値も改善していて他の治療ではなかなか見られないデータだ。長期的な安全性や有効性をしっかりと確認したい」と話していました。

Translation

First Clinical Trial of Heart Disease Treatment Using iPS Cells Conducted: Transplantation via Catheter

June 12, 2026, 18:19

iPS Cells

A venture company originating from Keio University and others had announced the first clinical trial of transplanting heart cells created from iPS cells into patients with heart disease, using a catheter. The company stated that it led to treatments that were less burdensome for patients as it eliminated the need for open-chest surgery.

This was announced at a press conference on June 12th by a medical venture company originating from Keio University, and Assistant Professor Hideki Kobayashi (小林秀樹) of Shinshu University Hospital.

The company was developing a new treatment method in which heart muscle cells were created from iPS cells, processed into a spherical shape, and then transplanted into the heart through a catheter from a blood vessel in the hip joint of patients who had severe heart disease.

In March of this year, the first clinical trial involved a male patient in his 70s with “dilated cardiomyopathy” which was a severe heart disease. So far, there had been no serious complications, and improvement in heart function was observed one month after the surgery.

The company planned to perform transplants on a total of 14 people over the next three years to confirm safety and effectiveness.

Another heart disease treatment using iPS cells, approved by the government this year, required open-chest surgery. The company said the new method would lead to treatment that minimized the burden on the patient.

Assistant Professor Kobayashi said, "The cardiac function values ​​have also improved, and such data are rarely seen in other treatments. We want to thoroughly confirm the long-term safety and effectiveness."

So, Japan has carried out the first clinical trial of transplanting heart cells created from iPS cells into patients using a catheter. By using a catheter, the treatment that could reduce burden on patients as it eliminates the need for open-chest surgery. This is good news for many patients with heart disease.