As you may have heard in the news, or read about in the press release we issued, the European Court of Justice just ruled that inventions based on the use of human embryonic stem cells (hESCs) for scientific research cannot be patented, when the process of deriving those cells destroys embryos.
This ruling is most unfortunate, and represents a huge setback to hESC-based research and development in Europe. However, it should have minimal impact on our commercial efforts in the EU.
As you probably know, the company is very keen to move forward with clinical programs in Europe, as well, and recently achieved some major milestones toward that goal. Most notably, we received clearance from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to initiate the first-ever hESC-based clinical trial in Europe, a Phase 1/2 trial for Stargardt’s Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from hESCs. Additionally, in June we announced a collaboration with Roslin Cells (UK) for storage and distribution of hESCs using our patented “embryo-safe” blastomere technique.
We do not consider today’s ruling to be a setback for our European programs, since they are based on our blastomere technique, and are moving full speed ahead with them. Simply put, our hESC programs do not require the destruction of the embryo, and as such are not affected by this ruling.
As was mentioned in our announcement, this court decision is actually narrower than has been reported in some places. As Greenpeace itself noted:
However, the decision will affect stem cell research only partially, as in recent years, researchers have found several alternative methods for obtaining stem cells, without the need to destroy human embryos.
Clearly our blastomere technology is first and foremost among these techniques.
This development could spur considerable European institutional and private sector interest in hESCs derived using techniques that do not destroy embryos, such as those that we are making available in collaboration with Roslin Cells. We certainly plan to meet such demand, toward one day making hESCs available to all European patients and researchers who may need them.
This ruling is a setback for the regenerative medicine sector in Europe, and a most unfortunate one. Nevertheless, it simply does not affect ACT directly, and we are eagerly anticipating starting our European clinical trial and other initiatives in coming months.
Chairman and CEO
Advanced Cell Technology, Inc