“Japanese regulators have conditionally approved two induced pluripotent stem cell therapies, one for Parkinson’s disease and another for heart failure, marking the first commercial approvals for the technology,” reports The Doomslayer.
Science explains:
Twenty years after they were first created in Japan, extraordinarily versatile stem cells made from the body’s own cells may finally realize their promise for regenerating diseased tissue. Last month, an advisory panel to Japan’s health ministry recommended limited marketing approval for therapies using induced pluripotent stem (iPS) cells for heart failure and Parkinson’s disease. In a controversial arrangement, their makers will be able to sell the products for 7 years while continuing studies to determine just how well the therapies work. IPS cells are moving closer to medical use in other countries as well, with dozens of potential therapies in clinical trials…
One of the new therapies, intended for heart disease patients, was developed by Kyoto University’s Center for iPS Cell Research and Application (CiRA) in collaboration with a University of Osaka group led by cardiovascular surgeon Yoshiki Sawa. Heart muscle cells derived from iPS cells are formed into small patches. Applied to a diseased heart’s surface, the muscle patches boost contraction while also releasing cytokines that promote blood vessel formation.
Eight heart disease patients have received RiHEART patches made by Cuorips, a startup spun off from the university. The company has reported in press briefings and two peer-reviewed papers—in Frontiers in Cardiovascular Medicine in 2022 and 2023—that there were no serious safety issues and patients’ heart function improved.
The Parkinson’s therapy, developed by a group led by neurosurgeon Jun Takahashi, CiRA’s current director, coaxes iPS cells to form replacements for the dopamine-producing neurons that die off in Parkinson’s. In a small pilot trial, surgeons drilled holes into the skulls of six Parkinson’s patients and injected the replacement cells. There were no safety issues, and four of the patients showed improvement 24 months after transplantation, Takahashi and colleagues reported in Nature last year. Sumitomo Pharma and RACTHERA are commercializing the treatment, dubbed Amchepry.
Scientists in Europe developed a new blood test that can detect Parkinson’s disease years before symptoms arise.
Before this test can become available in the U.S., it will have to be approved by the FDA, which can be very slow in approving useful medical tests. The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test held “the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the FDA’s delay in approving it. As Roger Parloff of Fortune noted, the FDA’s delay in approving the home HIV test is a “scandal.” It likely caused the deaths of thousands of people, given the mortality rate from AIDS.
“Study finds nicotine safe, helps in Alzheimer’s, Parkinson’s,” reported the Tampa Bay Times:
Smoking … contributes to an array of health problems, but nicotine — the calming chemical that cigarettes deliver — might actually be good for the aging brain. Smokers, for example, are less likely to develop Alzheimer’s disease — a phenomenon that has long puzzled scientists because smoking contributes to cardiovascular disease, which strongly increases the risk of Alzheimer’s. But closer investigation revealed that smoking doesn’t confer the protection; nicotine does.
A study of Alzheimer’s patients showed that those who wore nicotine patches were better able to remember and pay attention than those who didn’t. Another study showed that nicotine boosted cognitive function in older people who didn’t have Alzheimer’s, but were showing signs of age-related mental decline.
Nicotine also seems to protect against Parkinson’s disease, in which the death of cells in a small area of the brain results in tremors, impairing movement and as well as cognitive difficulties.
So what’s going on? How does the dreaded addictive component of cigarettes produce health benefits?
For starters, nicotine by itself isn’t very addictive at all, according to Dr. Paul Newhouse, the director of Vanderbilt University’s Center for Cognitive Medicine. Nicotine seems to require assistance from other substances found in tobacco to get people hooked….What makes nicotine especially attractive as a treatment is the fact it causes virtually no side effects, according to Newhouse. “It seems very safe even in nonsmokers,” he said. “In our studies we find it actually reduces blood pressure chronically. And there were no addiction or withdrawal problems, and nobody started smoking cigarettes. The risk of addiction to nicotine alone is virtually nil.”
If this study holds up, it is an additional reason to fight restrictions on nicotine delivery devices such as e-cigarettes, which, unlike cigarettes, do not emit smoke (which causes cancer). E-cigarettes emit vapor containing nicotine, not smoke.
