Cellular Dynamics and the National Eye Institute Establish a Cooperative Research and Development Agreement (CRADA) to Advance Cell Transplantation Therapy for the Treatment of Retinal Degenerative Disease using iPSC-Derived Cells

June 23, 2016

MADISON, WIS., June 22, 2016 - Cellular Dynamics International, Inc. (CDI), a FUJIFILM company, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Eye Institute (NEI), a division of the National Institutes of Health (NIH), to conduct research to advance a cell transplantation therapy for the treatment of retinal degenerative disease using retinal pigment epithelium derived from induced pluripotent stem cells (iPSC-RPE). The collaboration includes the joint development of an optimized biocompatible biodegradable scaffold that is likely to be a critical component for a potential future therapy.

Key Points

  • CDI will provide manufactured cells (iPSC-RPE and iPSC-endothelial cells) and optimize maintenance and cryopreservation media for iPSC-RPE growing on biodegradable scaffolds.
  • NEI will perform experiments to create functional iPSC-RPE cell tissue on scaffolds and evaluate iPSC-RPE efficacy in animal models. These experiments will also be used to evaluate Fujifilm recombinant peptide (RCP) as a scaffold material and to test methods of cryopreservation.
  • NEI and CDI will perform preclinical studies for HLA-matched iPSCs using established Good Manufacturing Practice (GMP)-compatible protocols with potentially up to five HLA iPSC lines.
  • Both NEI and CDI will guide advancement of the project by exchanging and jointly analyzing the results.
  • One aim of the agreement is for NEI and CDI to create a novel vascularized scaffold for the therapeutic transplantation of iPSC-RPE in ocular diseases, such as age-related macular degeneration.

Quote

Kaz Hirao, CDI Chairman and CEO, said, “While iPSC-derived cells have great potential for regenerative medicine applications, there are many hurdles yet to overcome. This agreement builds on the longstanding relationship between CDI and the National Eye Institute to address some of these hurdles, and may lead to IPSC-based therapies for patients with serious diseases of the eye.”

Sheldon Miller, Ph.D., Scientific Director at the NEI, said, “This is a multifaceted, collaborative effort with CDI to develop a therapeutic intervention against retinal degenerative disease. We are looking forward with great interest to the results of this commitment.”

About Cellular Dynamics International (CDI), a FUJIFILM company

Cellular Dynamics International (CDI), a FUJIFILM company, is a leading developer and manufacturer of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. The Company partners with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. CDI's technology offers the potential to create induced pluripotent stem cells (iPSCs) from anyone, starting with a standard blood draw, and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system produces billions of cells daily, resulting in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development. Founded in 2004 by Dr. James Thomson, a pioneer in human pluripotent stem cell research, Cellular Dynamics is based in Madison, Wisconsin, with a second facility in Novato, California. For more information please visit www.cellulardynamics.com and follow us on Twitter @CellDynamics.

FUJIFILM Holdings Corporation, Tokyo, Japan brings continuous innovation and leading-edge products to a broad spectrum of industries, including: healthcare, with medical systems, pharmaceuticals and cosmetics; graphic systems; highly functional materials, such as flat panel display materials; optical devices, such as broadcast and cinema lenses; digital imaging; and document products. These are based on a vast portfolio of chemical, mechanical, optical, electronic, software and production technologies. In the year ended March 31, 2015, the company had global revenues of $20.8 billion, at an exchange rate of 120 yen to the dollar. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com.

About the National Eye Institute

NEI leads the federal government's research on the visual system and eye diseases. NEI supports basic and clinical science programs to develop sight-saving treatments and address special needs of people with vision loss. For more information, visit https://www.nei.nih.gov/.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov/.

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