July 7, 2020

The Niche

Knoepfler lab stem cell blog

iPS cells Japan

2 min read

What’s better for stem cell trials such as for vision loss or Parkinson’s Disease: allogeneic or autologous cells? In a major shift earlier this year, the induced pluripotent stem (IPS) cell trial in Japan for treatment of macular degeneration (MD) switched gears from using the patients’ own cells (called “autologous”) to using banked cells from other people, termed “allogeneic”. Dr. Masayo Takahashi, the leader of this MD trial indicated the main reason was due to regulatory changes related to stem cells in Japan. This …Read More

2 min read

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 diseases. The two regulatory bodies aim to have the joint rules in place by 2015. To me this seems like a positive development, but it may come a bit …Read More