A Phase III trial investigating a method of maturing human eggs outside of the body using induced pluripotent stem cells (iPSC) has been given the green light after the US Food and Drug Administration (FDA) granted an investigational new drug (IND) application.
US-based Gameto will now launch its multi-centre US trial to establish the efficacy of its ovarian support cell (OSC) technology designed to mature eggs outside the body using iPSC technology, in a system the company argues requires 80% fewer hormonal injections than traditional in vitro fertilisation (IVF) methods.
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Primary endpoints in the upcoming double-blind, randomised trial will consider the safety and efficacy of viable embryos produced outside the body and improving pregnancy rate assessed at 12 weeks. Secondary endpoints will investigate embryo development alongside maternal health and live birth rates.
Dubbed Fertilo, the company describes its iPSC offering as able to use young ovarian support cells to recreate the natural egg maturation process in a dish. As a result, it has the potential to reduce the duration of treatment cycles down to two- or three-days while traditional methods rely on 10-14 days of high-dose hormonal stimulation to mature eggs.
Gameto’s chief scientific officer Christian Kramme said: “Gameto’s technology platform opens entirely new possibilities for addressing reproductive health challenges through cell engineering-inspired innovation.
“With Fertilo, we’ve demonstrated the potential of iPSC-based therapies to redefine fertility care by targeting ovarian health at the cellular level. This milestone also highlights the power of iPSCs in regenerative medicine and our computational and cell engineering platform where we have broader applications including menopause and ovarian cancer.”
Gameto is entering into a relatively competitive market in terms of infertility, with research by GlobalData estimating that infertility treatments across the seven major markets brought in $2.3bn last year, rising to $3.4bn by the end of 2030. This growth is down, in part, due to the number of individuals choosing to have children later in life.
GlobalData is the parent company of Clinical Trials Arena.
Approval for the company’s US Phase III trial comes after the company announced the first-ever live birth carried out as a result of its ovarian support cell system, to parents at the Santa Isabel Clinic, in Lima, Peru, in December 2024.
Gameto’s Fertilo builds on that of Japanese researcher Shinya Yamanaka, who won the Nobel Prize for Physiology and Medicine in 2012 for his discovery of iPSC.
Gameto co-founder Dina Radenkovic said: “By overcoming the major challenges of conventional IVF such as long treatment cycles, significant side effects, and the emotional and physical strain, Fertilo provides a potentially faster, safer, and more accessible solution for families. This milestone marks a turning point in reproductive health and highlights the first application of iPSC technology in IVF and the immense potential of our technology.”
Elsewhere in the world of IVF treatment, Spanish fertility biotech Oxolife has presented positive exploratory Phase II data for its non-hormonal fertility pill.
