ReHeart iPS-derived cardiac sheets: First clinical surgery and timeline

MBS News Japan

Overview

The first surgical procedure using ReHeart, an iPS cell-derived cardiac sheet, has been performed on a female patient in her 50s. Developed by Curopis, the technology received conditional and time-limited approval in March and entered insurance coverage on September 1.

In Depth

Key Findings

A female patient in her 50s has become the first person to undergo surgery using “ReHeart,” a cardiac sheet derived from iPS cells. In a press conference held on October 21 in Osaka, the patient reported that her postoperative recovery is proceeding smoothly and confirmed her discharge date for October 22.

Technical Details

ReHeart was developed by Curopis, a venture company originating from Osaka University. The surgical procedure involves applying the cardiac sheets directly to the heart through a small incision in the chest. This minimally invasive approach is designed to reduce the physical burden on the patient while aiming to improve the condition of patients suffering from severe heart failure.

Background and Context

The regulatory path for ReHeart included a conditional and time-limited approval for manufacturing and sales granted in March. Following this approval, the treatment became eligible for insurance coverage starting September 1. The surgery was performed by Yoshiyuki Sawa, the President of Osaka Police Hospital.

Significance and Outlook

The successful completion of this initial surgery marks the beginning of the practical application phase for iPS-derived cardiac sheets. To move toward full approval, Curopis has established a clinical goal to collect a total of 75 cases within the next seven years. The patient expressed high expectations for the treatment, stating her desire to return to daily activities and hobbies, such as walking her dog.

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