再生医学公司3DBio Therapeutics和theMicrotia-Congenital Ear Deformity Institute首次使用前者的3D印刷的Aurinovo Living Tissue植入物成功完成了人耳的重建。
The first-in-human Phase 1/2a clinical trial evaluated the safety and efficacy of AuriNovo for patients with microtia, a rare congenital deformity where one or both outer ears are absent or underdeveloped. 3DBio’s patient-specific living tissue implant was developed using 3D bioprinting technology to provide a viable treatment alternative to rib cartilage grafts and traditionally-used synthetic materials.
“As a physician who has treated thousands of children with microtia from across the country and around the world, I am inspired by what this technology may mean for microtia patients and their families,” said Arturo Bonilla, a leading pediatric ear reconstructive surgeon who performed the procedure. “This study will allow us to investigate the safety and aesthetic properties of this new procedure for ear reconstruction using the patient’s own cartilage cells.
“My hope is that AuriNovo will one day become the standard-of-care replacing the current surgical methods for ear reconstruction requiring the harvesting of rib cartilage or the use of porous polyethylene (PPE) implants.”
3DBIO的专有生物打印技术
3D生物打印领域正在看到有关功能组织和植入物的打印的持续进展，仅最后几个月就看到了bioprinted diabetes treatments,safer biodegrable breast implants， 和alternatives to animal testing.
生物印刷也使创造更多realistic and accurate anatomical models和surgical guidesto aid the training, planning and outcomes of various medical procedures.
3DBio is a clinical-stage regenerative medicine firm aiming to solve medical challenges with its 3D bioprinted living tissue implants. The firm manufactures its implants via its suite of novel and proprietary bioprinting hardware and materials, including its GMPrint 3D bioprinter, ColVivo bioink, specialized cell culture system, and implantable protective Overshell technology.
奥里诺沃is the firm’s first bioprinted product, a patient-specific, supportive living tissue implant designed for surgical reconstruction of the external ear in people born with microtia. Essentially, the implant is a collagen hydrogel scaffold encapsulating a patient’s own auricular cartilage cells that is bioprinted in the exact size and shape to match the patient’s opposite ear.
目前，Aurinovo在1/2A期的临床试验中对患者的耳部重建进行了评估，该试验已经被授予孤儿药和罕见的小儿疾病指定。美国食品药品监督管理局(FDA)。事实上,3 dbio的整个3 d biop专有rinting platform has been specifically engineered to meet the FDA’s requirements for therapeutic manufacturing.
Trialing ear reconstruction in humans
根据《美国医学遗传学杂志》的报道，每年，Microtia会影响美国大约1500名婴儿。3DBIO的Aurinovo植入物旨在为传统方法提供耳朵重建的替代方法，其中包括侵入性软骨移植物和合成替代品。
“The AuriNovo implant requires a less invasive surgical procedure than the use of rib cartilage for reconstruction,” said Bonilla. “We also expect it to result in a more flexible ear than reconstruction with a PPE implant. The AuriNovo living tissue implant is designed to provide a better solution for patients born with microtia by transforming their appearance and building their confidence and self-esteem.”
The implant is created by first 3D scanning a patient’s unaffected ear to specifically match the implant’s geometry, before the patient’s own auricular cartilage cells are incorporated into 3DBio’s ColVivo bioink. The full-size, living tissue implant is then 3D bioprinted using the firm’s GMPrint bioprinter in order to replace the patient’s microtia-affected ear.
3DBIO首席执行官兼联合创始人Daniel说：“对于Microtia患者而言，这是一个真正的历史时刻，对于再生医学领域，我们开始展示下一代组织工程技术的现实应用。”科恩。“这是我们公司七年的高潮；为开发一个独特的差异化技术平台的重点努力，满足了FDA对重建植入物治疗制造的要求。”
The Phase 1/2a clinical trial is currently evaluating the safety and efficacy of the AuriNovo implant for use in reconstructive surgeries in humans. The trial will collect assess data that will be measured across a number of mediums, such as overall satisfaction scores from surgical outcomes and questionnaires.
The trial expects to enroll 11 patients and is being conducted in sites across Los Angeles, California, and Texas. The Texas site is home to the Microtia-Congenital Ear Deformity Institue, which has been helping children born with microtia and other ear deformities since 1996.
“We believe that the microtia clinical trial can provide us not only with robust evidence about the value of this innovative product and the positive impact it can have for microtia patients, but also demonstrate the potential for the technology to provide living tissue implants in other therapeutic areas in the future,” Cohen added.
With its first bioprinted implant having completed its first successful reconstructive surgery during the first-in-human clinical trials, 3DBio is looking to widen the scope of its proprietary 3D bioprinting technologies.
Cohen说：“我们的最初迹象集中在重建和骨科领域的软骨上，包括治疗复杂的鼻缺陷和脊柱变性。”
“We look forward to leveraging our platform to solve other high impact, unmet medical needs like lumpectomy reconstruction and eventually expand to other organs.”
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特色图片显示a 3D printed AuriNovo “living” ear for reconstruction in Microtia patients. Photo via 3DBio Therapeutics.
