July 9, 2020

The Niche

Knoepfler lab stem cell blog

IPSC

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