Advanced Cell Technology, Inc. (OTC Bulletin Board: ACTC), of Marlborough, Mass., said on February 23 that it has been issued a U.S. patent on its “single-blastomere” technique.
The patent (No. 7,893,315) broadly covers ACT’s proprietary single-blastomere technology that provides a non-destructive alternative for deriving human embryonic stem cell (hESC) lines, the company said.
“[This patent] will help us accelerate our progress on a number of fronts, including deriving embryonic stem cells which meet the regulatory standards of the European Medicines Agency and the U.S. Food and Drug Administration, using the single-blastomere technology,” said interim CEO Gary Rabin. “We are developing a collaboration for creating banks of these cells using our proprietary technique with the United Kingdom’s Roslin Cells. This is an example of the type of potentially revenue-generating future partnership that we think this IP (intellectual property) protection could help facilitate.”
The single-blastomere technology uses a one-cell biopsy approach similar to pre-implantation genetic diagnosis (PGD), which is widely used in the in vitro fertilization (IVF) process and does not interfere with the embryo’s developmental potential.
The stem cells generated using this approach are healthy, completely normal, and differentiate into all the cell types of the human body, including insulin-producing cells, blood cells, beating heart cells, cartilage, and other cell types of therapeutic importance.
The safety record for one-cell biopsy as part of PGD now has a 15-year track record, and is carried out routinely as part of IVF processes around the world. ACT’s “embryo-safe” technique has been published in been peer-reviewed journals such as Nature and Cell Stem Cell.
“This patent issuance represents recognition of the innovation underlying our single-blastomere technology,” said Robert Lanza, M.D., chief scientific officer of ACT. “In the United States alone, more than 100 people die every hour from diseases that could potentially benefit from this ‘embryo-safe’ technique. Single cells are removed from the embryos, which remain healthy and continue to develop normally at rates consistent with whole (non-biopsied) embryos. Furthermore, this IP protection follows on the issuance of a broad patent relating to ACT’s production and therapeutic use of Retinal Pigment Epithelial (RPE) cells in 2010. We are eagerly anticipating the start of the two Phase 1/2 clinical trials in the first half of this year. Our RPE program uses hESCs derived from a single blastomere, and as such, this source of embryonic stem cells has been subjected to extensive regulatory scrutiny in order to demonstrate their safety and suitability to be used in human patients on a trial basis.”
ACT has been issued clearance from the FDA to proceed with two Phase 1/2 clinical trials in the United States for its RPE program, including a Phase 1/2 trial in patients with dry age-related macular degeneration.