The CiRA Foundation ("CiRA_F") is pleased to announce that two cell lines from the HLA homozygous iPS cell stock for clinical use have been registered as a Drug Master File ("DMF") of the U.S. Food and Drug Administration ("FDA").

Background

CiRA_F manufactures iPS cells for clinical use from the blood of healthy donors and provides them to research institutions and companies at a reasonable price.

We have registered our iPS cell stock as a DMF to facilitate companies that are conducting research and development on regenerative medicine using our iPS cell stock to apply for approval in the U.S.

Registered iPS cell lines

We have registered 2 of our 27 lines from our HLA homozygous iPS cell stock (ID: QHJI01s04 and QHJI14s04). These iPS cell lines were manufactured from the blood of a donor with the most frequent HLA type in Japan (donor ID: QHJI). Currently, more than 10 projects by other institutions are transplanting cells produced from these cells into patients and conducting clinical trials to confirm their safety and efficacy.

Contents of this DMF

The DMF that we have registered contains information in line with FDA requirements, including the eligibility of the donor (QHJI), the production method of the iPS cells, the quality evaluation results, and the basis for safety confirmation of the reagents and other materials used.

What is the Drug Master File System

The DMF system is a voluntary registration system with the FDA that includes information on the ingredients of drug products and drug additives.

Companies developing regenerative medical products using our iPS cell stock must submit detailed information about the stock when submitting applications to the FDA. Registering the cell lines as a DMF will simplify these procedures.

CiRA_F will continue to contribute to the development of regenerative medicine using iPS cells by strengthening cooperation with research institutions and companies.

Funders

Research Center Network for Realization of Regenerative Medicine, Japan Agency for Medical Research and Development (AMED)

Inquiries

The CiRA Foundation
Public Relations Group, Planning Department
E-mail：contact*cira-foundation.or.jp
(please change the * to @)