July 9, 2020

The Niche

Knoepfler lab stem cell blog

stem cells Japan

5 min read

Every year in December I go out onto a limb and make stem cell predictions for the coming year as I did in late 2017 for this year. Then usually around the 1/2-way point through the year I check in on how the predictions are faring so far at that point. In this post I give my 2018 predictions (pasted below) the 1/2-way point checkup. Things are off to a reasonably strong start for the old stem cell crystal ball.  For the grading, green is …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

3 min read

A team of researchers at RIKEN and Kobe City Medical Center reported at a press conference today a serious adverse event in a clinical trial participant receiving an induced pluripotent stem cell (IPS cell)-based therapy for vision loss. According to Japan Times and Yahoo! Japan (in Japanese), the patient in question in the IPS cell trial for macular degeneration developed a problem with his eye following the cell transplant. From Yahoo! Japan: “The patient had an operation on Monday to remove pre-retinal membrane, deemed to …Read More

3 min read

The journal Nature published an excellent editorial earlier this week on stem cell oversight and stem cell clinics. The piece, entitled ” FDA should stand firm on stem-cell treatments. US regulators must regain the upper hand in the approval system” struck just the right balance. It correctly supported the FDA’s data-centered approach to stem cell oversight and indicated that this regulatory system is not too harsh. At the same time, the editorial also rightly asserted that the FDA cannot simply stick entirely to the status quo …Read More