World First Clinical Study of iPSC-derived Corneal Epithelial Cells

World First Clinical Study of iPSC-derived Corneal Epithelial Cells


  • Post By : Kumar Jeetendra

  • Source: Microbioz India

  • Date: 06 Apr,2020

AMSBIO report on a world first clinical study of iPSC-derived corneal epithelial cells by Professor Ryuhei Hayashi and co-workers from the Graduate School of Medicine, Osaka University, Japan using StemFit Basic03 clinical grade stem cell culture medium and iMatrix-511 recombinant laminin E8 fragments.

SEAM (Self-formed Ectodermal Autonomous Multi-zone) of ocular cells, generated from human induced pluripotent stem cells, used to generate sheets of ocular surface ectoderm for transplant (Courtesy Hayashi et al.)

In this ground-breaking work, corneal epithelial sheets from HLA-homozygous iPS cells were produced using and transplanted into patients with corneal epithelial stem cell deficiency. The clinical study was approved by the Japanese government and the first transplant was performed in July 2019 with four transplantations planned in total.

When interviewed about his group’s pioneering work – Professor Hayashi commented “In the framework of clinical study, we consulted with the PMDA on Japanese standards for biological materials and referred to their opinions. Beneficially StemFit® Basic03 and iMatrix-511 had already been approved for clinical use by our Pharmaceuticals & Medical Devices Agency, so no additional data or paperwork were required. It was very helpful”. Professor Hayashi added “Previously, we had tried other feeder culture, but the StemFit/iMatrix-511 combination showed the most stable growth. For our application we found the compatibility with corneal differentiation was very good, it is stable and has no problems. In addition, because StemFit® Basic03 has good clinical compatibility, we have been able to conducting experiments using it from the basic research stage to eliminate the effects of changing the medium”.

Completely free of animal- and human-derived components (and also available as GMP Grade, made in USA under US cGMP) StemFit® Basic03 from AMSBIO is proven to provide highly stable and reproducible culture condition for Induced Pluripotent Stem and Embryonic Stem cells under feeder-free conditions during the reprogramming, expansion and differentiation phases of stem cell culture. StemFit® Basic03 combines high colony forming efficiency with lower than standard media volume consumption to offer cost effective colony expansion when compared to leading competitors.

To read the interview with Professor Hayashi in full, and to learn more about StemFit® Basic03 stem cell culture medium please visit or contact AMSBIO on +44-1235-828200 / +1-617-945-5033 / [email protected].

Founded in 1987, AMS Biotechnology (AMSBIO) is recognized today as a leading transatlantic company contributing to the acceleration of discovery through the provision of cutting-edge life science technology, products and services for research and development in the medical, nutrition, cosmetics and energy industries. AMSBIO has in-depth expertise in extracellular matrices to provide elegant solutions for studying cell motility, migration, invasion and proliferation. This expertise in cell culture and the ECM allows AMSBIO to partner with clients in tailoring cell systems to enhance organoid and spheroid screening outcomes using a variety of 3D culture systems, including organ-on-a-chip microfluidics.

For drug discovery research, AMSBIO offers assays, recombinant proteins and cell lines. Drawing upon a huge and comprehensive biorepository, AMSBIO is widely recognised as a leading provider of high-quality tissue specimens (including custom procurement) from both human and animal tissues. The company provides unique clinical grade products for stem cell and cell therapy applications these include high quality solutions for viral delivery (lentivirus, adenovirus and adeno-associated virus) in addition to GMP cryopreservation technology.

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