Notice on our iPS cell stock “QHJI01s04”

RESEARCHES

We manufacture and stock safe and quality-assured iPS cells and provide them to academic
research institutions and companies for clinical use.

A clinical study using our iPS cell stock, QHJI01s04, was conducted at Keio University Hospital,
with the results recently published in a scientific paper*¹. The clinical study reported the detection
of a genetic mutation in the EP300 gene,*² listed in the Cancer Gene Census (an expert-curated
database of cancer-related somatic mutations), in a corneal endothelial cell substitute used in the
first transplantation.

Neither the EP300 mutation nor other mutations registered in the Cancer Gene Census were detected
during genome-wide analysis of all our shipments of the QHJI01s04 cell line. Furthermore, to date,
no cancer-related adverse events have been reported by other institutions using this cell line.
At this time, even as the efficacy of cell therapy using this cell line has been demonstrated, no obvious
effects of the mutation have been observed in the patient participating in the clinical study.
Therefore, we will continue to provide the QHJI01s04 cell line for clinical use.

We have promptly explained the details, including the above decision, to researchers using this cell line
for clinical development and have not received any objections thus far.

Regarding this clinical research, we will work with Keio University if additional analysis is necessary during patient follow-up. In addition, we will continue to monitor the situation closely and strive to share information with researchers conducting clinical development using our iPS cell stock.
Please refer to the paper below for additional details of the study.

*¹ Paper Details

  • Title
    A first-in-human clinical study of an allogenic iPSC-derived corneal endothelial cell substitute transplantation for bullous keratopathy
    https://doi.org/10.1016/j.xcrm.2024.101847別サイトへ
  • Journal
    Cell Reports Medicine
  • Authors
    masatoshi Hirayama1, Shin Hatou1,2, Masaki Nomura3, Risa Hokama1, Osama Ibrahim Hirayama1, Emi Inagaki1,4, Kumi Aso1, Tomoko Sayano1,2, Hiromi Dohi3, Tadaaki Hanatani3, Naoko Takasu3, Hideyuki Okano4, Kazuno Negishi1, Shigeto SHimmura1,5
  • Author Affiliations
    1. Department of Ophthalmology, Keio University School of Medicine
    2. Cellusion Inc.
    3. CiRA Foundation
    4. Department of Physiology, Keio University School of Medicine
    5. Department of Clinical Regenerative Medicine, Fujita Medical Innovation Center, Fujita Health University

*²EP300
A gene encoding an enzyme that acetylates histones on chromosomes. It is known to be involved in cellular homeostasis by activating genes around the acetylation sites.


Contact

Public Relations Office
CiRA Foundation
Email: contact*cira-foundation.or.jp
(Change * to @.)

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