A Ministry of Health expert panel meeting to review marketing approval for regenerative-medicine products made using iPS cells. February19, the Ministry of Health, Labour and Welfare.
On February 19, a Ministry of Health panel, its subcommittee on regenerative-medicine products and biotechnology, signed off on conditional, time-limited approvals for two iPS-cell-based regenerative therapies, ReHeart and Amushepri. If the ministry follows through, these will become the world's first products made from induced pluripotent stem (iPS) cells to receive regulatory approval. This would be a milestone that could bring regenerative medicine a step closer to routine clinical use.
iPS cells are adult cells reprogrammed to regain the ability to develop into many different cell types. Shinya Yamanaka of Kyoto University first succeeded in creating this approach. Researchers have since pursued iPS-based medical treatments to repair damaged organs and tissues and to speed the development of new drugs.
A Transplant Alternative
ReHeart centers on a cardiac muscle sheet, a patch of heart tissue grown from iPS-derived cells. Yoshiki Sawa, a cardiovascular surgeon at the University of Osaka, led the underlying research. Cuorips (Tokyo), a company developing novel treatments for conditions such as heart failure, spearheaded the push for its commercial use.
The therapy targets patients with severe heart failure caused by ischaemic cardiomyopathy, for whom the traditional endgame has often been heart transplantation.
Rather than replacing the organ, surgeons attach the sheet to the surface of the heart through a relatively minor procedure. After it is applied, new blood vessels are said to form in the area, helping to repair damaged tissue. Cuorips says it has seen no major negative side effects and that clinical trials found evidence of efficacy.
Beyond Dopamine Pills
Amushepri targets progressive Parkinson's disease, a condition that steadily erodes motor functions and can leave patients struggling to walk. The research has been led by Jun Takahashi, a neurosurgeon at Kyoto University, with development undertaken by Sumitomo Pharma and RACTHERA, both based in Tokyo.
Parkinson's is driven, in large part, by the loss of the brain's dopamine-producing neurons, cells that help regulate movement. Treatment has therefore long revolved around drug therapy that tops up dopamine.
However, the approach has a built-in flaw. As the disease advances, the drugs' benefits can wane. Amushepri aims to tackle the deficit more directly, supporting the function of dopamine-secreting nerve cells in order to improve patients' motor abilities.
With the panel's endorsement in hand, both products are expected to receive formal approval from the Ministry of Health shortly.
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(Read the article in Japanese.)
Author: The Sankei Shimbun
