Stem cell biotech BioTime announced the news today that its subsidiary Cell Cure Neurosciences (Cell Cure) has filed an IND with the FDA for an embryonic stem (ES) cell-based therapy for Dry age-related macular degeneration (AMD). The product to be tested is OpRegen, which the company indicates is “the first IND for an ES cell-based …
BioTime Cell Cure Files IND with FDA for ES cell AMD therapy Read More »
In a major first for the stem cell and regenerative medicine fields, a patient in Japan today received a pioneering transplant of a retinal pigmented epithelial (RPE) sheet made from induced pluripotent stem (iPS) cells, also known by the acronym IPSC. This is the first ever iPS cell-based transplant into a human. The patient is …
Landmark: patient receives first ever iPS cell based transplant Read More »
What happens if we start using induced pluripotent stem (iPS) cells clinically in humans? A cool new paper recently came out that gets us closer to being able to predict an answer. It’s an important question as iPS cell-derived cellular products are getting closer to clinical use. For example, the first iPS cell-based clinical trial …
Cool, encouraging new preclinical study on monkey iPS cells Read More »
The voting is over and we have our top 12 finalists for the 2013 Stem Cell Person of the Year Award. You can see the final votes results below. It’s definitely an intriguing list that reflects the range of important areas in the field today. I can say without any hesitation that all 12 of …
Dozen Finalists for Stem Cell Person of the Year 2013 Read More »
Nominations for Stem Cell Person of the Year 2013 closed last night and I ended up with a remarkable list of 30 nominees. I have included a few sentences about each one below, often taking verbiage directly from the nominator. The online voting on these nominees will start soon. The top vote getters will move …
Stem cell technology is poised to wow the world with biomedical advances in the coming decades and Japan wants to lead the way. They want to forge ahead particularly with applications that focus on a relatively new kind of stem cells called induced pluripotent stem cells or iPS cells. Japanese researcher, Shinya Yamanaka, first reported production …
Japan Aiming For a Commanding Position on New Stem Cells Read More »
In a rare sign of stem cell international regulatory unity, the Japanese Health Ministry (厚生労働省) and the US FDA have agreed to develop a joint, unified regulatory framework for clinical studies of human iPS cells for use in treating retinal diseases. Presumably the rules would also guide clinical use of iPS cells to treat other …
FDA & Japanese Health Ministry (厚生労働省) To Develop iPS cell clinical rules Read More »
The iPS cell field has run fast and furious over the past 6 years reaching a big milestone surprisingly quickly on Monday with Shinya Yamanaka winning the Nobel Prize. But is the field going too fast? In August I argued that iPS cells are not quite ready for primetime (i.e. clinical trial studies). Now in …
Are iPS cells being rushed to the clinic or has their time come? Read More »