In a first, a French biotechnology company Kallistem has obtained human spermatogenesis in vitro i.e. created human sperm cells in a lab setup.
Kallistem develops innovative cell culture technologies in reproductive biology and its latest achievement is the ability to produce fully formed human spermatozoa in the laboratory setting, using patient testicular biopsies containing only immature germ cells, or spermatogonia.
Scientists around the world have been trying to create human sperm cells in-vitro for nearly two decades. Pegged as a rather complex physiological process that takes 72 days in vivo, Kallistem utilised two innovative and patented technologies that meet current regulatory standards for its research.
Kallistem is setting up a therapeutic development project for patients whose fertility is at risk. Pre-clinical trials of this technology are expected to last until 2016, with clinical trials starting in 2017. Kallistem’s five-year objective is to market its technologies under license to suppliers in the assisted reproductive technology market, as well as selling them directly to public and private fertility clinics.
Kallistem estimates that the market potential for treatment of male infertility is worth over €2.3 billion ($2.58 billion), with more than 50,000 new patients each year. In developed countries, the number of spermatozoa per ejaculate has halved over the last fifty years.
“Kallistem is addressing a major issue whose impacts are felt worldwide: the treatment of male infertility. Our team is the first in the world to have developed the technology required to obtain fully formed spermatozoa in vitro with sufficient yield for IVF using ICS. This is a major scientific outcome that enhances both our credibility and our development potential,” said Isabelle Cuoc, CEO of Kallistem.
“We are targeting a global market worth several billion euros in which there are currently no players. This should convince future financial partners to participate in Series A funding, which we expect to take place before the end of 2015.”
Therapeutic approaches for patients in this area are limited. For example, there is currently no treatment to preserve the fertility of pre-pubescent boys undergoing gonadotoxic treatment such as chemotherapy. This affects over 15,000 young cancer patients worldwide. Nor is there any solution for adult males living with infertility not addressed by current treatments.
Over 120,000 men live with non-obstructive azoospermia. Kallistem aims to meet the needs of these patients. From a testicular biopsy, it will be possible to obtain spermatozoa that will be cryopreserved until the man wishes to father a child, and then used in ICSI in vitro fertilization.
