У пятерых из шести детей при помощи генной терапии восстановился слух и улучшилось распознавание речи без серьёзных последствий для здоровья. Сообщает пресс-служба Массачусетской офтальмологической и отоларингологической больницы (MEE).
Фонд естественных наук Китая, Национальная ключевая программа исследований и разработок Китая, Комиссия по науке и технологиям муниципалитета Шанхая и Shanghai Refreshgene Therapeutics в сотрудничестве с исследователями MEE восстановили слух у людей с наследственной глухотой DFNB9.
DFNB9 — это дефект гена отоферлина (OTOF) — белка, который участвующего в преобразовании механического звукового раздражения волосковых клеток улитки внутреннего уха в нервные импульсы.
Исследование, началось в декабре 2022 года и длилось 26 недель. 6 детей с DFNB9 находились под наблюдением в Глазной и ЛОР-больнице Фуданьского университета. Специалисты Mass Eye and Ear использовали аденоассоциированный вирус (AAV), несущий здоровую версию гена OTOF.
У пациентов изначально была полная глухота. После экспериментального лечения у пяти детей восстановился слух: они свободно общаться и у них значительно улучшилось восприятие речи.
Во время наблюдения за пациентами появились 48 нежелательных явлений, но большинство (96%) были легкой степени тяжести, а остальные временные и не имели серьёзных последствий.
Эксперимент представляет собой первое клиническое испытание на людях генной терапии для лечения глухоты, с наибольшим количеством исследуемых и с самым длительным наблюдением на сегодняшний день. Результаты эксперимента опубликованы 24 января в журнале “The Lancet”, а также будут представлены 3 февраля на ежегодном собрании Ассоциации исследований в области отоларингологии.
Чжэн-И Чен, доктор философии, доцент лаборатории «Итон-Пибоди» в Массачусетском центре глаз и ушей кафедры отоларингологии-хирургии головы и шеи в Гарвардской медицинской школе: «Результаты этого исследования действительно замечательные. Мы видели, как слух детей резко улучшался каждую неделю, а также восстанавливалась речь».
По данным ВОЗ в мире от глухоты и других форм слуховых нарушений страдает 460 млн человек. Значительная доля подобных случаев связана с инфекционными болезнями и травмами. Многие пациенты теряют слух в течение жизни или не имеют его с рождения из-за определенных мутаций в генах TMC1, NOX3, OTOF и примерно в 100 других участках всего ДНК.
В настоящее время не существует одобренных препаратов для лечения наследственной глухоты, что открыло двери для новых решений, таких как генная терапия.
«Мы первые, кто инициировал клинические испытания генной терапии OTOF. Очень приятно, что наша команда перевела работу с фундаментальных исследований модели DFNB9 на животных, на восстановление слуха у детей с DFNB9», — сказал ведущий автор исследования Илай Шу, доктор медицинских наук из глазной и ЛОР-больницы Фуданьского университета. Ранее Шу работал научным сотрудником в лаборатории Чена в Mass Eye and Ear, – «Я искренне воодушевлен нашей будущей работой над другими формами генетической тугоухости, чтобы обеспечить лечение большего числа пациентов».
Результаты способствуют пониманию безопасности введения AAV во внутреннее ухо человека. Исследователи полагают, что подобным образом можно лечить и другие генетические заболевания. В дальнейшем планируется расширить выборку и отслеживать результаты в длительной динамике.
«С тех пор, как 60 лет назад были изобретены кохлеарные имплантаты (воздействующие на слуховой нерв напрямую – прим. редакции), не существовало эффективного лечения глухоты, — сказал Чен, – это огромная веха, которая символизирует новую эру в борьбе со всеми типами потери слуха».
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Комментарий:
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