Clinical research must be conducted carefully to acquire convincing data showing that this treatment is safe and useful.
The Health, Labor and Welfare Ministry has approved an Osaka University clinical research plan to use induced pluripotent stem (iPS) cells, which can develop into various kinds of body tissue, to treat patients with heart disease. A team led by Prof. Yoshiki Sawa, a cardiovascular surgery expert, will start the treatment as early as within this fiscal year.
The team plans to grow iPS cells provided by Kyoto University into heart muscle cells and process them into thin "sheets." Two sheets will be attached to the hearts of three patients, aged from 18 to 79, who have ischemic cardiomyopathy. This operation is intended to encourage the regeneration of heart muscle.
This will mark another step toward the practical application of iPS cells created in Japan.
Patients have high expectations for this treatment. The majority of patients with serious heart disease can be treated only through a heart transplant, but the number of donated organs is small. Osaka University's treatment method could become a new option for these patients.
It is vital that the team is dedicated to high-quality clinical research. It will need to show in detail how the patients' symptoms improved during the course of the treatment.
The research team previously attempted similar treatment using sheets made from cells taken from thigh muscles. Although a domestic manufacturer has commercialized these sheets, their effectiveness has yet to be assessed as being satisfactory.
Utilize ES cells, too
Some experts argue that at such a stage, it is "premature" to move forward with the use of iPS cells. The clinical research must wipe away these doubts.
Any side effects also will need to be closely watched. About 100 million iPS cells will be transplanted in the upcoming operations. If some of the iPS cells do not properly transform into heart muscle, they could become cancerous. Stringent quality control is a must, and the post-surgery condition of the patients should be carefully monitored.
The health ministry gave its approval on the condition that the procedure be restricted to patients with serious heart disease, and that informed consent documents be made easier for patients to understand. This is a natural approach considering the large risks involved in this research.
In 2014, a team from the RIKEN research institution and other entities conducted the first clinical trial using iPS cells to treat patients with an eye disease. The trial produced good results. Spurred by this, research in the field has gone from strength to strength and plans are in the works for clinical research and trials involving patients with ailments including spinal cord injuries and Parkinson's disease.
Osaka University's clinical research will be a touchstone that could determine the future course of regenerative medical techniques using iPS cells.
In the regenerative medicine field, research using embryonic stem (ES) cells, which are derived from human embryos, is the mainstream approach around the world. While ES cells have useful properties similar to those of iPS cells, ES cells were developed first and so their practical application is thought to be close.
In Japan, the National Center for Child Health and Development has started clinical trials using ES cells to treat patients with liver disease. These, along with iPS cells, should be used in developing treatments for intractable diseases.
(From The Yomiuri Shimbun, May 18, 2018)
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