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    Home > Biochemistry News > Biotechnology News > Next year, the world's first clinical trial of iPS cells to treat heart disease will be conducted.

    Next year, the world's first clinical trial of iPS cells to treat heart disease will be conducted.

    • Last Update: 2020-08-09
    • Source: Internet
    • Author: User
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    Japan's Ministry of Health, Labour and Social Security gave the green light to a team led by Osaka University heart surgeon Zefangshu in mid-May to approve the team's clinical research program to induce pluripotent stem cells (iPS cells) to treat heart disease, the second clinical application of iPS cells, the journal Nature reported.
    team plans to conduct the world's first clinical trial of iPS cells to treat heart disease next year.
    the Ministry of Health, Labour and Welfare issued "pass" to many researchers in the industry excited, but there are many people worried that the current regulatory means are not enough.
    iPS cell potential is huge so-called induced pluripotent stem cells, is the skin, blood and other body tissues in the formation of cells through reprogramming technology, induced into embryonic-like cells, thereby regaining the ability to differentiate into a variety of other types of cells.
    2006, Yamanaka, now director of the iPS Cell Research Institute at Kyoto University, used viral vectors to transfer a combination of four transcription factors into differentiated somatic cells, reprogramming them to get a cell type similar to embryonic stem cells, iPS cells.
    Wasayama was known as the "Father of iPS" and was awarded the Nobel Prize in Physiology or Medicine in 2012.
    iPS cells are a huge boon for regenerative medicine such as repairing damaged organs.
    Although it is difficult to avoid ethical controversy because of its use in the manufacture of reproductive cells, it faces less ethical controversy than real human embryonic stem cells, and is sought after by many scientists and medical professionals in the hope of trying to treat patients with this technology. a man in his 60s in Japan has become the first person in the world to receive retinal cells from other people's iPS cells,
    the British journal Nature.
    , Osaka University will use iPS cells to treat heart disease.
    repair the damaged heart, Zefang and colleagues used iPS cells to create a thin slice containing 100 million heart muscle cells.
    's research in pigs shows that transplanting these 0.1 mm thick, 4cm-long cell flakes into the pig's heart can improve their heart function.
    Zefangshu said the implanted cells are not integrated with heart tissue, and the main role of these heart muscle cells is to release growth factors to help the damaged heart muscle regenerate.
    it is understood that in the latest plan, they will use iPS cells provided by Kyoto University to culture myocardial cells into a disc-shaped heart muscle piece a few centimeters in diameter and about 0.1 mm thick, which will then be transplanted into the patient's heart to improve the patient's heart muscle function.
    scientists believe that one of the advantages of cell flakes is that they can create their own cell matrix and maintain structure without the need for stents made of foreign materials. "It's an elegant and intelligent way of cell delivery," said Philip Menacher, a heart surgeon at the European Hospital in Georges Pompidou, Paris,
    who was involved in the production of the tissue flakes.
    " Wolfram-Hubertus Zmermana, a pharmacologist at the University of Gerdingen Medical Center in Germany, is also developing a treatment for heart disease using iPS cells.
    he says the latest attempt is based on research by Zefang and colleagues over the past 15 years.
    Zefangshu's clinical trial will begin next year, with three patients initially treated, followed by seven, bringing the total to 10.
    if the technology proves safe and demonstrates some efficacy, the treatment could be commercially available under japan's "fast-track system" in the field of regenerative medicine.
    allows researchers to avoid expensive large-scale clinical trials designed to prove the efficacy of a treatment and use small-scale trials to prove its safety and efficacy. "This will be of worldwide concern because many groups are working in this direction," said Thomas Isenhagen, a pharmacologist and chair of the Cardiovascular Research Center at the University of Hamburg in Germany at
    .
    "experts worry about inadequate regulation, despite the academic community's bullish view of clinical trials, but concerns about its commercialization."
    fast-track system was launched in 2014 to accelerate the use of potential life-saving therapies.
    critics say the system is flawed because it allows people to sell the treatment to patients without enough data to prove it works. in addition, some researchers question whether the threshold for approving treatments for commercial use is too low,
    .
    even if these cells are safe, any surgery is risky, and patients are likely to abandon other treatments because of the treatment, which is less certain and may not be effective.
    ethicists and regulators agree that for any new treatment, its benefits must outweigh the value of risk. in addition to meeting safety requirements, researchers should prove that their treatment sought to be effective, which needs to be tested on more people, said
    , a cardiologist at Kyoto University in Japan.
    said the assessment process should be conducted using random, controlled clinical trials, which is the gold standard for medical research.
    "Although iPS cell therapy has great potential, we are not sure whether it really works due to the lack of control experiments."
    biggest problem is that Japan currently lacks an adequate assessment system.
    " spokesman for the Ministry of Health, Labour and Welfare disagreed, telling Nature that the current approval criteria were sufficient because researchers would still need to provide evidence of the effectiveness of the treatment even if it had been approved for commercial applications.
    for the current debate, Zefangshu agrees on the importance of controlling experiments to prove efficacy.
    he also pointed out that he still acts within the framework of Japanese rules - he doesn't need a control group experiment until it's commercialized.
    the Ministry of Health, Labour and Welfare approved the treatment by acknowledging that it was "scientifically reasonable and ethical" for testing patients, and that as to whether the treatment really worked, "we must find out now."
    .
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