Regenerative Medicine Column

Regenerative Medicine Column

ISSCR Special Edition:Regenerative Medicine and list of Regenerative Medicine Products Approved in Japan

This article is a special edition of the Regenerative Medicine Column distributed at the ISSCR Tokyo International Symposium 2021 held in October 2021. It introduces Remedy's Approach to Regenerative Medicine and list of Regenerative Medicine Products Approved in Japan.

• Regenerative Medicine Product
• Laws
• Product

Regenerative Medicine Column

Conditions for use of regenerative medicine products and specified medical care coverage system for clinical trials

In this article, we will explain the conditions under which regenerative medicine can be applied to treatment, as well as the system of uninsured concomitant therapy expenses for clinical trials.

• Clinical Trials
• Insurance System
• Laws

Regenerative Medicine Column

Gene therapy using genome editing technology– Noticeable CAR-T cells

Genome editing has become widely known since the CRISPR/Cas9 system won the Nobel Prize in Chemistry. What is “gene therapy using genome editing technology”? Also, what are CAR-T cells, which are attracting attention?

• Treatment and Technology
• New Trends
• Genes

Regenerative Medicine Column

DNA and Gene Therapy

The term “regenerative medicine products” refers to two types of products: “cell processed products” and “gene therapy products”. So what exactly is the “gene” in “gene therapy products”?　Let's take a deeper into the topic along with the products for gene therapy.

• Treatment and Technology
• Product
• Genes

Regenerative Medicine Column

Process until the environment to implement the development of the regenerative medicine field is established

There are not many major differences between pharmaceutical clinical trials and those for regenerative medicine products. However, there are a wide variety of specific clinical trial considerations about regenerative medicine products.

• Education
• Envioroment

Regenerative Medicine Column

History of regenerative medicine and its evaluation as a therapeutic technology

Many people have been coming to have high hopes for regenerative medicine. When did regenerative medicine treatments start? We will tell you how the treatment have been evaluated as a treatment technology.

• Treatment and Technology
• What is Regenerative medicine?

Regenerative Medicine Column

Differences between clinical trials for regenerative medicine products and pharmaceutical products

The Clinical trials for regenerative medicine products are different from those for conventional drugs. In this paper, we will explain 'clinical trials for regenerative medicine products'.

• Clinical Trials
• Regenerative Medicine Product

Regenerative Medicine Column

Regenerative Medicine-Related Laws. - Vol.3 -

Gene therapies are categorized as regenerative medicine under Japan’s Pharmaceutical and Medical Device Act.

• Laws

Regenerative Medicine Column

Regenerative Medicine-Related Laws. - Vol.2 -

The Act on Ensuring the Safety of Regenerative Medicine, etc. enacted in 2013 has placed a net of pre-regulation over free medical treatment using cell processing products, which was previously unregulated as part of the scope of doctors' discretionary authority.

• Laws
• Treatment and Technology

Regenerative Medicine Column

Regenerative Medicine-Related Laws. - Vol.1 -

In the Japan Revitalization Strategy announced in 2013, the government focused on regenerative medicine-related laws.

• Laws
• Regenerative Medicine Product

Regenerative Medicine Column

What is Gene Therapy Products?

In this article, we will be discussing gene therapy products with regard to regenerative medicine products as defined by the Pharmaceutical and Medical Devices Law (Pharmaceutical and Industrial Safety and Health Law). Specifically, what is gene therapy? Also, what is Zorgensma, which is also called billion-dollar new drug?

• Treatment and Technology
• Regenerative Medicine Product
• Genes

Regenerative Medicine Column

A Regenerative Medicine Product

Pluripotent stem cells, such as ES cells and iPS cells, are artificially created cells and do not exist in our bodies. So how are these cells created?

• Cells
• Regenerative Medicine Product
• Product

Regenerative Medicine Column

What is Regenerative medicine?

What image do you have of Regenerative medicine? Magic drug to remove nasolabial fold? Hair root regrowth or Cloned human?

• What is Regenerative medicine?
• Regenerative Medicine Product