首页 > 资讯 > 女性健康技术开发商Gameto公布数据证明用于生育护理的体外成熟解决方案的临床级制造能力

女性健康技术开发商Gameto公布数据证明用于生育护理的体外成熟解决方案的临床级制造能力

泰然健康网
2025-06-22 12:04

Manuscript demonstrates Gameto's manufacturing process resulted in ovarian support cells of improved efficacy, quality and safety for in vitro maturation applications

手稿表明，Gameto的制造过程提高了卵巢支持细胞在体外成熟应用中的功效、质量和安全性

NEW YORK, May 8, 2024 /PRNewswire/ -- Gameto, a female-led biotechnology company with a mission to redefine women's healthcare, today announced new research outlining the cellular engineering and manufacturing techniques underlying Fertilo, their novel investigational in vitro maturation (IVM) solution containing engineered ovarian support cells (OSCs) to mature eggs outside of the body.

2024年5月8日，纽约/PRNewswire/-Gameto是一家以女性为主导的生物技术公司，其使命是重新定义女性的医疗保健，今天宣布了一项新的研究，概述了Fertilo的细胞工程和制造技术，Fertilo是他们的新型研究性体外成熟（IVM）解决方案，其中含有工程化卵巢支持细胞（OSC），可以在体外成熟卵子。

These data underscore that Gameto's quality by design strategic product development supports the manufacturing of OSC-IVM for clinical and commercial use..

这些数据强调，Gameto的按设计质量战略产品开发支持OSC-IVM的临床和商业制造。。

'This study is the first to demonstrate the end-to-end process by which a therapy developed from induced pluripotent stem cells (iPSC) has the potential to enhance in vitro fertilization (IVF) outcomes and advance women's health, paving the way for its application in clinical settings,' said Dr. Dina Radenkovic, Chief Executive Officer and co-founder of Gameto..

Gameto首席执行官兼联合创始人迪娜·拉登科维奇（Dina Radenkovic）博士说：“这项研究首次证明了从诱导多能干细胞（iPSC）开发的疗法具有增强体外受精（IVF）结果和促进女性健康的潜力，为其在临床环境中的应用铺平了道路。”。。

Gameto's novel approach uses cellular engineering to create a pure population of highly potent ovarian support cells (OSCs) from a female clinical-grade human induced pluripotent stem cell (hiPSC) line that recreates the dynamic, bidirectional follicular environment in a dish when co-cultured with immature eggs.

Gameto的新方法使用细胞工程从女性临床级人类诱导多能干细胞（hiPSC）系中产生纯高效卵巢支持细胞（OSC），当与未成熟卵共培养时，该细胞系在培养皿中重建动态的双向卵泡环境。

Gameto has previously published that co-culturing immature human eggs with OSCs results in higher rates of egg maturation and euploid embryo formation.1.

Gameto先前发表过，将未成熟的人类卵与OSC共培养会导致更高的卵成熟率和整倍体胚胎形成率。

'This study highlights the core underlying mechanism of action of our ovarian support cells in maturing eggs outside of the body and provides a deeper look into the role that Fertilo plays in promoting high quality egg maturation for IVF treatment,' said Dr. Christian Kramme, Chief Scientific Officer of Gameto.

Gameto首席科学官克里斯蒂安·克拉姆（ChristianKramme）博士说：“这项研究突出了我们的卵巢支持细胞在体外成熟卵子中的核心潜在作用机制，并深入研究了Fertilo在促进IVF治疗中高质量卵子成熟中的作用。”。

'We are effectively creating an active cell therapy in a dish, which differs significantly from the media solutions that are currently used for in vitro maturation. These data suggest the applications of this technology could expand beyond OSC-IVM and be used to address additional women's health and fertility issues as well.'.

“我们正在有效地在培养皿中创建一种活性细胞疗法，这与目前用于体外成熟的培养基溶液有很大不同。这些数据表明，这项技术的应用可以扩展到OSC-IVM之外，并用于解决其他女性的健康和生育问题。”。

These data demonstrate how Gameto developed a clinical-grade manufacturing process for Fertilo, including using GMP-grade raw materials and a commercial-grade hiPSC line to yield a highly scalable, consistent, and potent production of their OSCs for clinical use. The researchers also found a high degree of similarity between OSCs derived from hiPSCs and the natural support cells of the ovary, compared with available data of in vivo ovaries from the human cell atlas..

这些数据展示了Gameto如何为Fertilo开发临床级生产工艺，包括使用GMP级原料和商业级hiPSC生产线，以产生高度可扩展，一致且有效的OSC生产，用于临床。研究人员还发现，与人类细胞图谱中体内卵巢的可用数据相比，源自hiPSC的OSC与卵巢的天然支持细胞之间存在高度相似性。。

Additionally, using the same gene engineering method for both research-use-only hiPSCs and clinical-grade hiPSC lines resulted in OSCs that were similar on a molecular and functional level. These results suggest Gameto could broaden its platform to include a wider range of donor cells, such as those derived from patients, for potential uses like disease modeling.

此外，在两项研究中使用相同的基因工程方法，仅使用hiPSC和临床级hiPSC系，导致OSC在分子和功能水平上相似。这些结果表明，Gameto可以扩大其平台，以包括更广泛的供体细胞，例如来自患者的供体细胞，用于疾病建模等潜在用途。

This supports a potential expansion into additional applications and indications within women's health and fertility medicine..

这有助于在女性健康和生育医学中扩展到其他应用和适应症。。

The manuscript, titled 'Reproducible differentiation of pure ovarian support cells from clinical-grade hiPSCs as a novel infertility treatment,' is available on a preprint server at https://www.biorxiv.org/content/10.1101/2024.04.29.591741v1, and Gameto is submitting it for scientific peer-review for potential publication..

该手稿名为“临床级hiPSC中纯卵巢支持细胞的可重复分化作为一种新型不孕症治疗方法”，可在预印本服务器上获得https://www.biorxiv.org/content/10.1101/2024.04.29.591741v1，Gameto正在将其提交给科学同行评审以供潜在出版。。

Gameto is currently engaged in rigorous preparations to meet the FDA's conditions for Phase 3 trial initiation. For more information about Gameto and how the company is redefining women's healthcare, visit gametogen.com.

Gameto目前正在进行严格的准备工作，以满足FDA启动第三阶段试验的条件。有关Gameto以及该公司如何重新定义女性医疗保健的更多信息，请访问gametogen.com。

Fertilo, Gameto's lead investigational program, is a solution derived from induced pluripotent stem cells (iPSC) and designed to mature eggs outside of the body as part of minimal hormonal stimulation cycles for in vitro fertilization and egg freezing. Gameto's goal in developing Fertilo is to make fertility treatments more convenient, safer, and accessible for a wider patient population.

Gameto的主要研究项目Fertilo是一种源自诱导多能干细胞（iPSC）的解决方案，旨在使卵子在体外成熟，作为体外受精和卵子冷冻的最小激素刺激周期的一部分。Gameto开发Fertilo的目标是使生育治疗更方便，更安全，更广泛的患者群体更容易获得。

Fertilo has received different regulatory classifications in foreign jurisdictions, and after consultation with national regulators, has been cleared for commercialization in Australia and in large markets in Latin America..

Fertilo在外国司法管辖区接受了不同的监管分类，在与国家监管机构协商后，已获准在澳大利亚和拉丁美洲的大型市场进行商业化。。

Gameto is a biotechnology company developing novel treatment solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body.

Gameto是一家为女性健康开发新型治疗方案的生物技术公司，从不孕症开始。Gameto汇集了一支经验丰富、富有远见和激情的科学管理团队，开发一套产品套件，为女性的整个生育过程提供支持。Gameto的主导项目Fertilo旨在通过减少体外成熟卵子的激素注射，使体外受精和卵子冷冻更短，更安全，更容易获得。

Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of North America's largest fertility network Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen and on LinkedIn..

Gameto由医生出身的企业家Dina Radenkovic领导，Dina Radenkovic担任首席执行官和连续企业家，也是北美最大的生育网络Prelude fertility的创始人，Martin Varsavsky担任主席。有关更多信息，请访问gametogen.com或在Twitter、Instagram@gametogen和LinkedIn上关注我们。。

Investor ContactKylie Jordankylie@gametogen.com

投资者联系人KylieJordankylie@gametogen.com

Press ContactAlexis FeinbergGametoPR@westwicke.com

新闻联系人AlexisFeinbergGametoPR@westwicke.com

1 Piechota S, Marchante M, Giovannini A, et al. Human-induced pluripotent stem cell-derived ovarian support cell co-culture improves oocyte maturation in vitro after abbreviated gonadotropin stimulation. Hum Reprod. 2023;38(12):2456-2469. doi:10.1093/humrep/dead205

1 Piechota S，Marchante M，Giovannini A等人。人类诱导的多能干细胞衍生的卵巢支持细胞共培养可在短促性腺激素刺激后改善卵母细胞的体外成熟。嗡嗡声。2023年；38（12）：2456-2469。doi:10.1093/humrep/dead205