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".
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".
Professor Hayashi, Graduate School of Medicine, Osaka University, Japan
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.