Terumo Begins the World's First Clinical Study of Cardiac Regenerative Therapy Using Cell Sheets

Terumo Corporation (Headquarters: Shibuya-ku, Tokyo, Japan. President: Yutaro Shintaku) announced today that it will begin a clinical study in Japan of a cardiac regenerative therapy using cell sheets.

This study has been selected as one of the projects of "Super Special Consortia for Supporting the Development of Cutting-edge Medical Care" ("Tokku"). The Super Special Consortium is a special program, established as a part of the Japanese government's science and technology policy, that generates special treatments and controls for research funds. The initiative conducts parallel discussions with supervising departments and agencies, on a trial basis, in order to eliminate disincentives to the development of innovative technologies.

In "Project to initiate and promote regenerative medicine using cell sheet engineering", led by Dr. Teruo Okano, a professor of Tokyo Women's Medical University, out of which is for cardiac regenerative therapy area, clinical research has been advanced by Dr. Yoshio Sawa, a professor of Osaka University. Terumo has an important role in bringing it from the stage of clinical research to that of clinical study.

Restoring Cardiac Function with Skeletal Myoblast Sheet

The cardiac regenerative technology that is being developed by Terumo is expected to improve the condition of severe heart failure by affixing the autologous myoblast sheets on the damaged sites of patient's heart muscle. The skeletal myoblasts are harvested from the muscle in the patient's thigh, extracorporeally cultured and formed into sheets.

Because the skeletal myoblasts are harvested from the patient's own body, they can be used on the patient with low risk of rejection or infection, and they can be cultured outside the body.

Terumo has been engaging in R&D activities for cardiac regenerative technology since 2002 and began developing cell sheets in 2007. With the clinical study, it aims to receive an approval for the manufacture and sales of this technology in the future.

Reference: About the Treatment of Heart Disease

Heart Failure is generally defined as the inability of the heart to supply sufficient blood flow to meet the needs of the body. In the cases of severe heart failure, implantation of a ventricular assist system and heart transplantation are treatment options.

In 2008, approximately 230,000 people were suffering from heart failure and approximately 60,000 people died of the disease in Japan. Furthermore, these figures are rising annually. The medication therapy and surgical treatment for heart failure are advancing, however the recovery is still difficult when the condition becomes severe. Thus, a new treatment for heart failure is eagerly anticipated.

Overview of the clinical study

1. Subjects: Patients suffering from severe heart failure due to ischemic heart disease

2. Methods

<Exploratory study>

Number of Cases: 6

Participating institutions: 3 (Osaka University, and others)

Period: 6 months post-transplant (2-year follow-up)

<Confirmatory study>

It will be conducted with a larger number of subjects in the study design established based upon the results of the exploratory study.

3. The process, from harvesting skeletal muscle to sheet transplantation

The skeletal myoblasts harvested from patient's skeletal muscle will be cultured, frozen, formed into sheets, and then transplanted.

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  Cell culture at Terumo facility

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  Skeletal myoblast sheet