January 21, 2021

The Niche

Trusted stem cell blog & resources

IPSC

7 min read

IPS cell research is a growing area of promise for regenerative medicine. These stem cells, also known as iPSCs or more formally as Induced Pluripotent Stem Cells, are engineered cells that are programmed to function the same way as embryonic stem cells. They can be differentiated into possibly any type of cell that is needed for therapeutic purposes. Since iPSC production was first reported by Shinya Yamanaka using mouse and human cells in 2006 and 2007, respectively, cells from a whole host of species have …Read More

3 min read

It’s notable how the FDA now considers gene-editing a kind of regenerative medicine. This means that various gene therapy products in development technically qualify as regenerative therapies. Ever since the agency began its rapidly growing regenerative medicine advanced therapy (RMAT) designation program, we’ve seen an increasing number of gene therapy biotechs and products qualify as RMATs. As a result, the RMAT-qualified gene therapies get to go into a speedier lane of FDA oversight. Today’s post is a mix of recommended reads in the regenerative …Read More

2 min read

365 days a year, 24 hours a day stem cells are growing in labs around the world, providing a never-ending stream of data and products, with real hope, good news, and lots of surprises. You can see some past examples of good news in the stem cell and regenerative medicine field highlighted on The Niche here. Today’s post brings 2 examples of recent good news and a brain organoid surprise. And one bonus more about space and when you’d run out of air (or not …Read More

2 min read

In the past month or two there has been a steady stream of good news in the stem cell and regenerative medicine world. Here are three examples. Fate Therapeutics announced the first US IND for an induced pluripotent stem cell (IPSC)-related product. Its cleared product, FT500, is an off-the-shelf natural killer-based cancer immunotherapy. I expect more to come in the next couple years so good news now and likely more to come. IPSC-based trials are picking up in Japan too with trials related to …Read More

2 min read

Where do things stand with IPS cell translational research? The newest development is that regulators in Japan just have given conditional approval to an Osaka University team to an induced pluripotent stem (IPS) cell-based study for ischemic heart disease. For years IPS cell-based products have been on-again off-again in active clinical study for macular degeneration, work led by Dr. Masayo Takahashi. The new heart disease study is led by Yoshiki Sawa. This appears to be the third conditionally approved IPS cell study in Japan. I’m not …Read More

4 min read

By Agnes Soos Amid the hustle and bustle of downtown Boston, nearly four thousand researchers and exhibitors gathered for the 15th Annual ISSCR Meeting. With presentations from over thirty plenary lectures, and dozens of others featured in concurrent sessions and the daily Innovation Showcases, there definitely was no shortage of exciting research to discover and discuss. There was a record number of exhibitors this year with over 150 companies set up in Exhibit Hall. Added to this, the always-busy Meet-Up Hubs, the job boards …Read More

3 min read

Shinya Yamanaka is one of my favorite fellow scientists. His research is creative and rigorous along with having huge clinical implications. At the same time, Dr. Yamanaka sees the big picture and he’s very open about talking about real life as a scientist. I really appreciate both levels. In the past I interviewed him for my blog on the clinical use of IPS cells. In a new interview with Yamanaka by The Japan Times, he says quite a lot of important things. The field should …Read More

4 min read

It’s been a great couple days so far here at the World Stem Cell Summit in Atlanta. You can follow it on Twitter using the #WSCS15 hash tag. I first attended it 5 years ago in Pasadena. One of the special aspects of WSCS is it brings together diverse stakeholders in a way that just doesn’t happen elsewhere. For instance, you can have the FDA, patients, physicians, scientists, and funding agency people all in one room together. Some strong impressions so far include the …Read More

9 min read

Masayo Takahashi (高橋 政代) on IPSC Trial for Macular Degeneration By Michael Cea Stem Cell Analyst & Advocate (editor’s note: piece was originally posted on Michael’s blog here; follow Michael on Twitter @msemporda) Having followed closely the developments in programs using pluripotent based therapeutics I was fortunate during ISSCR2015 to have the opportunity to sit down with Dr Masayo Takahashi to discuss her pioneering efforts to translate Shinya Yamanaka’s groundbreaking iPS technology for debilitating retinal conditions. As most everyone is aware, the first iteration of the …Read More

4 min read

The big stem cell news already this week is the acquisition by Fujifilm of Cellular Dynamics International (CDI) for a whopping $307 million dollars or about $16.50 per CDI share. You can read the press release here. Update: The entity is now known as Fujifilm Cellular Dynamics. It was less than two years ago that CDI did its IPO with an initial offering of about $46 million. Fujifilm reportedly has a multibillion-dollar war chest for buying into the life sciences sector and a growing interest in regenerative …Read More