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2013年6月29日 (土)

iPS臨床研究 再生医療の実用化に近付くか

The Yomiuri Shimbun June 29, 2013
Hopes high for clinical iPS studies
iPS臨床研究 再生医療の実用化に近付くか(6月28日付・読売社説)

A big step has been taken toward realizing regenerative medicine using human induced pluripotent stem cells, or iPS cells.

A panel of the Health, Welfare and Labor Ministry has given the go-ahead to the Kobe facility of Riken, a governmental scientific research institute, and another research organization, to conduct clinical studies using iPS cells in the treatment of age-related macular degeneration.

This unprecedented clinical research project, scheduled to be launched as early as the summer of 2014, should be conducted to reliably determine the effectiveness and safety of iPS-based regenerative medicine.

Age-related macular degeneration is a currently intractable eye disease that can appear as part of aging. It damages part of the retina cells in the back of the eye and distorts the field of vision, causing loss of sight.

Danger of cancer

In the project, iPS cells will be created from a patient’s skin cells and cultivated to form cell sheets that will be attached to the retina. The researchers in the project will select six patients for whom medication and other currently available remedies have not been effective.

The planned iPS clinical application will certainly heighten expectations among those who suffer the eye disease, who are estimated to number about 700,000 throughout the country.

It is believed, however, that five years or more will be required before age-related macular degeneration patients in general can receive iPS treatments, as the clinical research project will be followed by therapeutic trials.

It is especially problematic that iPS cells have the possibility of turning cancerous. This is believed to be because genes that can trigger cancer have to be used in the process of making iPS cells.

It is appropriate that the ministry’s panel approved the clinical studies on the condition that those genes be eliminated before iPS cell sheets are transplanted onto retinas.

Although the eye is generally considered not to be prone to developing cancer, it is impossible to forecast with 100 percent accuracy what cellular anomalies could take place after the transplant of the iPS cell sheets to patients. As much attention as possible should be paid to the danger of cancer and other risks that are as yet unforeseen.

Establishing safety is imperative for securing public trust in regenetrative medicine.

Applications are also planned for the treatment of such conditions as serious heart diseases and spinal cord injuries due to road accidents. Many countries have been engaging in fierce competition in iPS cell reseach and development projects.

As Japan is one of the world’s most advanced countries in basic studies of iPS cells, we hope this country will spearhead international competition in terms of iPS applications as well. It is crucial to steadily advance the project through trilateral cooperation between industry, academia and the government.

Key bills carried forward

Creating an environment more conducive to supporting iPS R&D projects is also a must.

The government has deemed regenerative medicine through iPS applications to be one of the centerpieces of the nation’s growth strategies, hammering out a policy of providing 110 billion yen in subsidies for iPS studies in the coming 10 years. The passage in April of a law to promote regenerative medicine for encouraging practical applications of iPS technologies can give a boost to the envisioned goal.

Meanwhile, a bill to revise the Pharmaceutical Affairs Law to simpify screening procedures for regenerative medicine products to speed up government authorization, as well as a bill for a new law to regulate potentially problematic therapies to secure the safety of regenerative medicine, failed to pass the last Diet session. Deliberations on the bills have been carried forward to the next sitting of the legislature.

The bills should be enacted through in-depth discussions in an extraordinary Diet session to be convened in autumn.

(From The Yomiuri Shimbun, June 28, 2013)
(2013年6月28日01時27分  読売新聞)


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