Health
Children with total deafness regain hearing after ‘groundbreaking’ gene therapy: ‘Like a miracle’
Five children who were born completely deaf have had some reversal of hearing loss after receiving a “groundbreaking” gene therapy.
The clinical trial, which was co-led by Mass Eye and Ear in Boston and the Eye & ENT Hospital of Fudan University in Shanghai, was the first in the world to apply gene therapy to children in both ears, according to the researchers.
The research has just been published in Nature Medicine on June 5.
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In addition to regaining their hearing, the children participating in the trial — who ranged in age from 1 to 11 years old — were also able to identify the origins and locations of sounds, even in noisy environments, researchers said.
This was a follow-up to an earlier trial that began in Dec. 2022, in which the research team successfully performed the gene therapy in just one ear. This new study showed that treating both ears led to even greater benefits.
Five children who were born completely deaf have had their hearing loss reversed after receiving a “groundbreaking” gene therapy. (Eye & ENT Hospital of Fudan University)
All the children in the study had a hereditary form of deafness called DFNB9, which is caused by mutations in the OTOF gene.
The condition occurs when the OTOF gene is unable to produce a protein called otoferlin, which is essential for transmitting sound signals from the ear to the brain.
As a result, the children could not hear or speak.
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“The children were chosen because they would benefit most from early intervention of gene therapy, especially in speech acquisition,” study author Zheng-Yi Chen, DPhil, an associate scientist in the Eaton-Peabody Laboratories at Mass Eye and Ear in Boston, told Fox News Digital in an interview.
“From a safety standpoint, however, it is more risky for children.”
How the procedure works
During the “minimally invasive” surgical procedure, the doctors administered an injection of the human OTOF gene into the children’s inner ears.
The children remained in the hospital for around seven to 10 days for observation.
“After four weeks, the kids showed hearing perception in tests, and then gradually they gained the ability to speak,” Chen said.
Dr. Yilai Shu is shown communicating with a young patient at the Eye & ENT Hospital of Fudan University. (Eye & ENT Hospital of Fudan University)
Within the families, response to sound was noticed within two to three weeks.
“All five patients have restoration of hearing, speech perception improvements, and sound source perception in noisy environments,” Chen said.
The participants experienced only low-grade adverse effects, such as fever and vomiting.
“This is the first time in history that hearing loss is being reversed by gene therapy.”
“There were no serious adverse effects,” he said. “They all recovered without any intervention.”
The gene therapy is intended to be a one-time treatment and will not need to be repeated, the researchers said, although the children will likely require speech therapy.
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Until now, there has not been any single treatment for hearing loss, other than cochlear implants, according to researcher Yilai Shu M.D., PhD, director of the Diagnosis and Treatment Center of Genetic Hearing Loss at Fudan Hospital in Shanghai.
“This is the first time in history that hearing loss is being reversed by gene therapy,” Shu told Fox News Digital. “And, of course, we believe this will have a profound impact on children’s lives.”
Dr. Yilai Shu’s team is pictured working in the lab of the Eye & ENT Hospital of Fudan University. (Eye & ENT Hospital of Fudan University)
Chang Yiyi, a mother in Shanghai whose 3-year-old son, Zhu Yangyang, participated in the trial, spoke to Fox News Digital about the experience.
“When Zhu couldn’t speak at 2 years old and didn’t have a response to sound, we realized there was a problem,” she said.
After hearing tests, it was determined that Yiyi’s son had total deafness.
“It was unbelievable — the best feeling. It was like a miracle.”
“He would get very frustrated because he couldn’t understand, couldn’t speak, couldn’t hear,” she said.
Twenty-three days after receiving the gene therapy, the boy first responded to someone calling out to him.
“It was unbelievable — the best feeling,” Yiyi told Fox News Digital. “It was like a miracle.”
“Now he can say ‘Mommy’ and ‘I want’ and some simple sentences.”
Dr. Yilai Shu (center) is pictured in the operating room at the Eye & ENT Hospital of Fudan University. (Eye & ENT Hospital of Fudan University)
Approximately 430 million people worldwide have disabling hearing loss, including 34 million children, according to the World Health Organization.
More than 50% of hearing loss cases are the result of genetics.
Gene therapy is promising but limitations exist, expert says
Dr. Amy Sarow, the Michigan-based lead audiologist at Soundly, a hearing health care marketplace, noted that gene therapy has had some success in the treatment of cancer and eye disease, along with other emerging areas.
“It is exciting to think about how gene therapy could impact millions of individuals with hearing loss worldwide,” Sarow, who was not involved in the experimental gene therapy, told Fox News Digital.
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“However, it is essential to emphasize that there are many causes of hearing loss, and one type of gene therapy will not be right for every type.”
Even among genetic causes of deafness, different genes may cause abnormalities or dysfunction that affect different auditory pathways, according to Sarow.
“Thus, development of specific treatment interventions is dependent on causality and will still take time to develop.”
Dr. Yilai Shu examines a young patient at the Eye & ENT Hospital of Fudan University. (Eye & ENT Hospital of Fudan University)
Additionally, Sarow noted, a “reversal” of hearing loss does not mean that an individual will have normal hearing ability fully restored.
“The first three years of life are very important to language acquisition, and although these children would be behind their normal-hearing peers (having spent the first few years of life profoundly deaf), they would still have the possibility to ‘catch up’ to some degree,” she said.
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“Research tells us that the younger the intervention, the better for potential language development.”
As with any intervention, there can be risks with gene therapy. “One potential risk is that treatment may not be successful in every case,” Sarow said.
“Another potential risk is that the targeted gene therapy may not work in the targeted region.”
What’s next?
The next step is to follow the trial patients for a longer time period to ensure that the positive results are stable, Shu said.
Until now, there has not been any single treatment for hearing loss, other than cochlear implants, according to one of the researchers. (iStock)
Based on the results of the first study, the researchers expect that the patients’ hearing abilities will continue to improve over time.
“Then we want to expand to older patients, and gauge how the treatment works for aging adults,” he said.
“Ultimately, we want the patient to have a choice about which treatment option they want to go with.”
The researchers also plan to start the process of seeking FDA approval to bring the gene therapy to the U.S.
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“We are working to bring this to people outside China, including the U.S., as quickly as possible,” Shu Fox News Digital.
The researchers also hope to extend this type of gene therapy to treat other types of deafness in the future.
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Small fragments of plastic were found in the tumors of most prostate cancer patients, according to a new study from NYU Langone Health.
In past studies, microplastics have been found in almost every human organ and in bodily fluids, but their impact on human health still isn’t fully understood.
The researchers analyzed tissue samples from 10 patients with prostate cancer who underwent surgery to remove the entire organ.
Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples, according to the study press release.
In past studies, microplastics were found in almost every single human organ along with bodily fluids, even the placenta. (iStock)
The cancerous tissue contained on average more than double the amount of plastic as healthy prostate tissue samples, the study found. This equates to about 40 micrograms of plastic per gram of tissue compared to 16 micrograms.
Researchers avoided contaminating the samples with other plastics by substituting standard tools with those made of aluminum, cotton and other non-plastic material, the release noted.
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The scientists say this is the first direct evidence linking microplastics to prostate cancer.
“By uncovering yet another potential health concern posed by plastic, our findings highlight the need for stricter regulatory measures to limit the public’s exposure to these substances, which are everywhere in the environment,” said senior study author Vittorio Albergamo, assistant professor in the department of pediatrics at NYU Grossman School of Medicine, in the release.
Using visuals of both benign samples and tumor samples, as well as specialized equipment, the scientists identified plastic particles in 90% of the tumor samples and 70% of benign tissue samples. (iStock)
The study findings were presented during the American Society of Clinical Oncology’s Genitourinary Cancers Symposium in San Francisco on Feb. 26.
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“What is most striking is not that microplastics were detected, but that they were found embedded within tumor tissue itself,” Dr. David Sidransky, oncologist and medical advisor at SpotitEarly, a startup that offers an at-home breath-based test to detect early-stage cancer, told Fox News Digital.
“While complete avoidance is unrealistic, people can take practical steps to reduce exposure.”
“We already know microplastics are present in water, air, blood and even placental tissue. Their detection in prostate tumors suggests systemic distribution and long-term bioaccumulation,” added Maryland-based Sidransky, who was not involved in the study.
Study limitations
Albergamo cautioned that a larger sample is needed to confirm the findings. Additionally, Sidransky noted that the presence of microplastics alone does not prove they cause cancer.
“Tumors can act as ‘biologic sinks,’ meaning they may accumulate circulating particles simply because of altered vasculature and permeability,” he said.
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A key unanswered question, according to the doctor, is whether microplastics are biologically active in ways that “promote DNA damage, immune modulation or chronic inflammation within the prostate.”
About one in eight men in the U.S. will be diagnosed with prostate cancer at some point in their lifetime, according to the Centers for Disease Control and Prevention.
The most actionable step men can take is appropriate screening and early detection, according to doctors. (iStock)
For those concerned about microplastics, Sidransky offered some insights.
“I believe the appropriate response is curiosity, not panic, and a commitment to understand more,” he said.
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“While complete avoidance is unrealistic, people can take practical steps to reduce exposure, such as minimizing heating food in plastic containers, reducing bottled water consumption when possible, and favoring glass or stainless steel alternatives.”
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The most actionable step men can take, however, is getting appropriate screenings to help ensure early detection, according to the doctor. Screening discussions should be individualized based on age, family history and other risk factors.
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There has been a shake-up in the Make America Healthy Again movement regarding glyphosate, a widely used herbicide that has been the subject of significant controversy.
The debate follows an executive order signed by President Donald Trump that ensures an adequate supply of elemental phosphorus and glyphosate-based herbicides related to national defense.
MAHA supporters have previously pushed a pesticide-free agenda, warning of potential health harms caused by glyphosate.
Dr. Marc Siegel, Fox News senior medical analyst, said he believes there is sufficient evidence linking glyphosate to neurodegenerative diseases, including ALS, Parkinson’s and multiple sclerosis, to warrant limiting exposure.
President Donald Trump signed an executive order that ensures an adequate supply of elemental phosphorus and glyphosate-based herbicides related to national defense. (AP Photo/Charlie Neibergall)
“With Parkinson’s, this association appears to be due to the gut, vagus nerve and brain axis, where the exposure affects the microbiome in the gut, which then ascends slowly up to the brain, causing the neurodegenerative disease years later,” Siegel told Fox News Digital.
“There is also a growing association being found between high-dose glyphosate or occupational exposure and metabolic disorders, liver disease and some cancers, specifically lymphoma.”
He added, “Growing research backs this. I favor limiting it.”
“When we apply them across millions of acres and allow them into our food system, we put Americans at risk.”
Studies have shown that glyphosate, which is used in products such as Roundup, owned by Monsanto, could raise cancer risk.
In one University of Washington study published in the journal Mutation Research, researchers found that exposure to it increased the risk of non-Hodgkin lymphoma by 41%.
The nonprofit Investigate Midwest, which analyzed data from both the U.S. Geological Survey and the National Cancer Institute, also recently found that pesticides may contribute to cancer rates.
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Among the top 500 counties for per-square-mile pesticide use, more than 60% had cancer rates above the national average of 460 cases per 100,000 people, according to the report.
Investigate Midwest, which is based in Illinois, interviewed more than 100 farmers, environmentalists, lawmakers and scientists as part of a partnership with the Pulitzer Center’s StoryReach U.S. Fellowship.
Among the top 500 counties for per-square-mile pesticide use, more than 60% had cancer rates above the national average of 460 cases per 100,000 people, according to one study. (iStock)
Iowa, which used 53 million pounds of pesticides last year, holds the nation’s title for second-highest cancer rate.
Bill Billings, a resident of Red Oak, Iowa, was diagnosed with cancer in 2014.
“The cancer specialist said, very directly, (my) cancer is a result of being exposed to chemicals,” Billings said in the report.
Kelly Ryerson, founder of Glyphosate Facts and owner of the Instagram account @glyphosategirl, told Fox News Digital her journey researching the herbicide began with her own health struggles.
Ryerson, who is based in California, previously struggled with chronic illness and autoimmune issues, which she said improved when she stopped eating gluten.
Iowa, which used 53 million pounds of pesticides last year, holds the nation’s title for second-highest cancer rate. (iStock)
After attending a medical conference at Columbia University’s Celiac Disease Center, Ryerson began to question modern farming practices rather than the gluten itself.
“A lot of times, farmers are spraying Roundup on our grains right before harvest to facilitate an easier harvest,” she said. “After that easier harvest, because everything’s dry at the same time, those crops go directly to the mill and may end up in our food supply, at alarmingly high levels.”
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In 2015, the International Agency for Research on Cancer (IARC), part of the World Health Organization framework, classified glyphosate as “probably carcinogenic to humans.”
The classification was based on limited evidence of cancer in humans (notably non-Hodgkin lymphoma in some studies) and sufficient evidence in experimental animals.
“President Trump’s executive order reinforces the critical need for U.S. farmers to have access to essential, domestically produced crop protection tools, such as glyphosate,” a Monsanto spokesperson said. (Wolf von Dewitz/picture alliance via Getty Images)
A spokesperson for Monsanto told Fox News Digital it will comply with Trump’s order to produce glyphosate and elemental phosphorus.
“President Trump’s executive order reinforces the critical need for U.S. farmers to have access to essential, domestically produced crop protection tools, such as glyphosate,” the spokesperson said.
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HHS Secretary Robert F. Kennedy Jr. has long been a vocal critic of Roundup, working with his legal team in 2018 to award $289 million to a man who alleged the weed killer caused his non-Hodgkin lymphoma, according to reports.
Following backlash to Trump’s executive order, Kennedy said he supports the order but acknowledged that “pesticides and herbicides are toxic by design, engineered to kill living organisms.”
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“When we apply them across millions of acres and allow them into our food system, we put Americans at risk,” he posted on X. “Chemical manufacturers have paid tens of billions of dollars to settle cancer claims linked to their products, and many agricultural communities report elevated cancer rates and chronic disease.”
Fox News Digital reached out to the White House for comment.
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