August 6, 2020

The Niche

Knoepfler lab stem cell blog

Japan stem cells

3 min read

The Japan stem cell and regenerative medicine oversight system has been designed to move investigational therapies forward fast, much faster than the systems in other countries such as the U.S. But how well is it working so far? It’s an important question both for that country and more globally as the Japanese system was touted by some as a model and a reason why the U.S., to remain more competitive in this industry. Some of the same folks felt that the U.S. should also …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

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

A patient in Japan has reportedly filed suit against a fat stem cell clinic and has won a judgement of 1.84 million yen in total (about $15,000 USD). The Tokyo District Court reportedly ruled in favor of the patient and most of the award is reimbursement. Authors Ikka, et al report on the case and changes in Japanese law overseeing regenerative medicine in a new Cell Stem Cell piece. The Mainichi reports that the female patient sought treatment from the stem cell clinic for “numbness …Read More