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Japan keeps edge in stem-cell medicine with heart study

Homegrown iPS technology gives the nation a leg up in regenerative therapies

Induced pluripotent stem cells have the potential to treat diseases that standard therapies cannot handle. (Courtesy of Shinya Yamanaka at Kyoto University)

TOKYO/OSAKA -- Japan's decision on Wednesday to greenlight a study using stem cells for treating heart failure shows how far the field has progressed in the decade since the cells were first developed.

The health ministry approved Osaka University's clinical trial to test induced pluripotent cells in cases of ischemic cardiomyopathy, a condition in which the heart is weakened by a reduced supply of blood. iPS technology reprograms mature cells to become stem cells that can then be used in a variety of regenerative treatments. 

"It'll probably take several years, but we're determined and prepared to do all we can to save even one more patient," professor Yoshiki Sawa, who leads the research team, told reporters Wednesday.

The study will use cells from donors -- which can be transplanted into patients faster -- supplied by Kyoto University's Center for iPS Cell Research and Application.

Kyoto University professor Shinya Yamanaka, who serves as the center's director and won a Nobel prize for his pioneering work in the field, said he would "keep a close eye on" the study's progress and ensure a sufficient supply of high-quality cells.

Sawa reckons the procedure could benefit several thousand patients in Japan, estimating the cost in the tens of thousands of dollars. "It would be good to get it to around the same level" as cardiac regenerative medicine products already on the market, he said.

The approval should boost prospects for other iPS cell research, an area where Japan is a world leader.

Kyoto University professor Jun Takahashi plans to begin a clinical trial as early as this year for a Parkinson's disease therapy that involves implanting dopamine-producing neurons cultivated from donor-derived iPS cells. The death of such neurons causes the condition. The university's iPS research center also is looking into a treatment for thrombocytopenia, or low platelet levels, which makes it harder for blood to clot.

Keio University professors Hideyuki Okano and Masaya Nakamura are researching treatment of spinal cord injuries by transplanting stem cells that can develop into nerve cells at the damaged areas.

More Japanese businesses focus on regenerative medicine as well, betting on it as the next big growth driver after falling behind U.S. and European rivals in other cutting-edge fields.

Sumitomo Dainippon Pharma, an early partner of Kyoto University, has been particularly active. The company teamed with Japan's Riken research institute on retinal-cell trials begun in 2014 -- the first use of iPS cells in disease treatment -- and is involved in the Parkinson's disease and spinal cord injury research as well. It partnered with Riken-affiliated biopharma startup Healios, which licensed the retinal therapy from the institute, and plans to begin a clinical trial this year.

Sumitomo Dainippon also completed an Osaka Prefecture plant in March to produce membranes and nerve cells from iPS cells.

"There's a first-mover advantage, so it's extremely advantageous for us to have a production structure established," said Toru Kimura, a board member and head of the company's cellular and regenerative medicine department. "We'll take the plunge and invest."

Fujifilm Holdings aims to expand its portfolio across the regenerative medicine space. The company in 2015 acquired Cellular Dynamics International, an American producer of iPS cells, and now looks to bring therapies to market.

Fujifilm partnered with Takeda Pharmaceutical in February to conduct trials for an iPS cell-based heart failure treatment, seeking to take advantage of the drugmaker's expertise.

The growth of regenerative medicine should boost a wide array of ancillary fields including cell cultivation equipment, reagents and shipping services. Startups also are sprouting to build on the fruits of academic research.

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