The Yomiuri Shimbun A team led by a RIKEN researcher conducted the world’s first clinical trial last Friday involving induced pluripotent stem (iPS) cells, which can develop into various types of cells, being transplanted into a patient suffering from age-related macular degeneration.
But some start-ups in the United States and Britain began conducting clinical tests using embryonic stem (ES) cells, which also have versatile applications, four years ago. These trials indicate the various challenges that lie ahead, including the necessity to ascertain the safety and effectiveness of regenerative medical treatments that use iPS cells.
But Maurie Hill, a 54-year-old woman who had an eye treated using ES cells two year ago, recalled that she was not as concerned about the risks involved. “I always think everything’s going to go fine,” she said at her home in a southern Vermont town 300 kilometers north of New York City. Hill added that she was happy she was able to undergo the process.
The Yomiuri Shimbun
She started rapidly losing her vision when she was 35. She was diagnosed at a hospital with Stargardt’s disease — a retinal ailment which leads to central vision loss. Caused by abnormalities in the retina, the disease is an inherited form of juvenile macular degeneration similar to age-related macular degeneration. Her vision loss continued to worsen, eventually leaving her unable to distinguish her neighbors.
In January 2012, Hill happened to hear a TV news report on a clinical trial using ES cells conducted by U.S. biotechnology company Advanced Cell Technology (ACT), Inc., which successfully improved the vision of a patient.
Soon afterward, she consulted with her doctor. She had an operation in July that same year to have retinal cells produced from ES cells injected into her left eye, which was in a much more serious condition than her right eye.
ACT has conducted clinical trials using ES cells for more than 30 patients suffering either from age-related macular degeneration or Stargardt’s disease. Though there have been no reports of serious problems such as cells turning cancerous, a concern shared with trials using iPS cells, vision has not improved for many patients. Unfortunately, neither has Hill’s.
Other firms are also facing challenges. Geron Corp., a U.S. clinical-stage biopharmaceutical company, failed to secure a sizable amount of funds needed for its clinical trials three years ago. The company was forced to suspend the world’s first clinical trial on the treatment of a damaged spinal cord using ES cells, bringing to the fore the difficulty in realizing the commercialization of regenerative medical treatment…..Read more:
source: The Japan News