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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Cases of gout are rising in younger individuals, according to a global study.
The condition, which is a type of inflammatory arthritis, steadily increased in people aged 15 to 39 between 1990 and 2021, researchers in China announced.
Although rates vary widely between countries, the total number of young people with the condition is expected to continue rising through 2035.
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The study, published in the journal Joint Bone Spine, investigated 2021 data from the Global Burden of Disease (GBD), spanning 204 countries within the 30-year timeframe.
The data measured gout prevalence, incidence and years lived with disability, tracking global trends over time. The results showed a global increase across all three outcomes.
Gout is expected to continue rising in young people through 2035. (iStock)
Prevalence and disability years increased by 66%, and incidence rose by 62%. In 2021, 15- to 39-year-olds accounted for nearly 14% of new gout cases globally, the study found.
Men from 35 to 39 years old and people in high-income regions had the highest burden, but high-income North America topped the list for highest rates.
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Men were also found to have lived more years with gout due to high BMI, while women tended to have the condition as a link to kidney dysfunction, the study noted.
The total number of cases is expected to increase globally due to population growth, but the study projected that rates per population would decrease.
The researchers noted that data quality, especially in low-income settings, could have posed a limitation to the broad GBD data.
What is gout?
Gout is a common form of arthritis involving sudden and severe attacks of pain, swelling, redness and tenderness in the joints, according to Mayo Clinic. It most often occurs in the big toe.
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The condition occurs when urate crystals accumulate in the joint. These form when there are high levels of uric acid in the blood, which the body produces when it breaks down a natural substance called purines.
A gout flare-up can happen at any time, often at night, causing the affected joint to feel hot, swollen, tender and sensitive to the touch.
Urate crystals, described as sharp and needle-like, build up in the joint, causing intense pain and swelling. (iStock)
Purines can also be found in certain foods, like red meat or organ meats like liver and some seafood, including anchovies, sardines, mussels, scallops, trout and tuna, according to the Mayo Clinic. Alcoholic drinks, especially beer, and drinks sweetened with fruit sugar can also lead to higher uric acid levels.
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Uric acid will typically dissolve in the blood and pass through the kidneys into urine, but when the body produces too much or too little uric acid, it can cause a build-up of urate crystals. These are described by the Mayo Clinic as sharp and needle-like, causing pain, inflammation and swelling in the joint or surrounding tissue.
Risk factors for gout include a diet rich in high-purine foods and being overweight, which causes the body to produce more uric acid and the kidneys to have trouble eliminating it.
Experts urge patients to seek medical attention for gout flare-ups. (iStock)
Certain conditions like untreated high blood pressure, diabetes, obesity, metabolic syndrome and heart and kidney diseases can increase the risk of gout, as well as certain medications.
A family history of gout can also increase risk. Men are more likely to develop the condition, as women tend to have lower uric acid levels, although symptoms generally develop after menopause.
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Untreated gout can cause worsening pain and joint damage, experts caution. It may also lead to more severe conditions, such as recurrent gout, advanced gout and kidney stones.
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The Mayo Clinic advises patients to seek immediate medical care if a fever occurs or if a joint becomes hot and inflamed, which is a sign of infection. Certain anti-inflammatory medications can help treat gout flares and complications.
Fox News Digital reached out to the researchers for comment.
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A new study suggests that annual mammograms may not be the only effective approach for preventing breast cancer.
The research, published in the Journal of the American Medical Association (JAMA), tested a risk-based breast cancer screening approach against standard annual mammography.
The WISDOM randomized clinical trial, led by study authors from universities and healthcare systems across the U.S., considered more than 28,000 women aged 40 to 74 years old, splitting them into a risk-based screening group and an annual mammography group.
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Researchers calculated each woman’s individual risk based on genetics (sequencing of nine breast cancer genes) and other health factors.
A new study suggests that annual mammograms may not be the only effective approach for preventing breast cancer. (iStock)
Those who were at the highest risk were advised to alternate between a mammogram and an MRI scan every six months. Patients with elevated risk were told to get an annual mammography and counseling.
Average-risk women were guided to get mammograms every two years, while low-risk individuals were advised to have no screening until they became higher risk or reached age 50.
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The researchers found that risk-based screening did not lead to more advanced cancer diagnoses (stage 2B or higher) compared with annual screening, indicating that it is just as safe as traditional methods. The risk-based approach, however, did not reduce the number of biopsies overall, as researchers had hoped.
Among the risk-based group of women, those with higher risk had more screening, biopsies and detected cancers. Women at lower risk had fewer procedures.
The research, published in the Journal of the American Medical Association (JAMA), tested a risk-based breast cancer screening approach against standard annual mammography. (iStock)
“[The] findings suggest that risk-based breast cancer screening is a safe alternative to annual screening for women aged 40 to 74 years,” the researchers noted in the research summary. “Screening intensity matched individual risk, potentially reducing unnecessary imaging.”
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Fox News medical contributor Dr. Nicole Saphier, associate professor of radiology at Memorial Sloan Kettering Cancer Center in New Jersey, commented that while these findings are important, the study “completely sidelines” what screenings are designed to do — detect cancer early.
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“If you don’t measure stage 0, stage 1 or stage 2A cancers, you can’t tell whether personalized screening delays diagnosis in a way that matters for survival and treatment intensity,” Saphier, who was not involved in the study, told Fox News Digital in an interview.
Those who were at the highest risk were advised to alternate between a mammogram and an MRI scan every six months. (iStock)
More than 60% of breast cancers in the U.S. are diagnosed at stage 1 or 2A, where cure rates exceed 90%, the doctor noted.
The trial doesn’t “fully evaluate” whether risk-based screening changes detection at the earliest and most treatable stages, where screening “delivers its greatest benefit,” according to Saphier.
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“Mammography is not without risk — radiation exposure, false positives, anxiety and potential over-diagnosis are real and should be acknowledged,” she said. “But it remains the most effective, evidence-based tool for detecting breast cancer early, when treatment is most successful.”
The expert added that labeling women under 50 as “low risk” is “outdated,” as breast cancer diagnoses are on the rise in younger females.
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“Until long-term mortality data support alternative approaches, annual screening beginning at 40 for average risk women should continue,” Saphier added. “Women should be assessed for breast cancer risk by 25 years old to determine if screening should begin earlier.”
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