Insception Biosciences Inc., a privately-held company that develops stem cell treatments, announced it has received approval from the Food and Drug Administration (FDA) to begin human clinical studies of a new stem cell treatment, which offers an alternative to bone marrow transplants.
Cord blood, which offers a rich source of blood stem cells, is now clinically accepted as a viable alternative to bone marrow or peripheral blood as sources of stem cells for transplantation and treatment of a variety of blood, cancer, and genetic disorders. To date, one of the barriers to the widespread use of cord blood has been the low number of stem cells in cord blood samples. This has, by and large, limited its use to pediatric patients.
However, Insception Biosciences' new cellular product, called INSC01, contains an enriched number of stem cells from umbilical cord blood which will broaden the use of cord blood stem cells for adult transplants.
"This is a major milestone, not only for Insception but also for the advancement of cord blood stem cell treatments," says Dr. Laura Grey, VP Research and Business Development at Insception Biosciences. "Cord blood is not only an alternative stem cell source to bone marrow, it provides the significant advantages of being easily collected and can be stored as a frozen product, which means it is readily available with minimal waiting times. Ultimately, this technology could be applied in the future to help patients who cannot find a suitable donor or who cannot afford to wait for a bone marrow transplant."
On any given day, there are approximately 6,000 patients in the U.S. alone requiring a bone marrow transplant but have no donor, according to the U.S. National Marrow Donor Program. There are also hundreds of Canadians in need of bone marrow transplants each year to treat a wide variety of illnesses, including blood-related diseases such as leukemia, and inherited immune system and metabolic disorders, according to the Canadian Blood Services. For most of these patients, a bone marrow transplant may be the last and best chance for recovery from a serious illness. Many will die waiting for a suitable match.
"Without question, umbilical cord blood has already had a dramatic impact on the application of bone marrow transplantation, particularly for those awaiting a bone marrow transplant who cannot find a matched donor. However, it is also unequivocally clear that the number of stem cells in an umbilical cord blood sample is the most critical determinant influencing the probability of a cure," says Dr. John Wagner, director of the Blood and Marrow Transplant
Program at the University of Minnesota, one of the world's most experienced cord blood transplant centers. "For this reason, products like Insception Biosciences' INSCO1, based on expanding the number of stem cells in cord blood, are critical to dramatically advancing the application of cord blood transplants."
Increasingly, cord blood is being used for bone marrow transplants worldwide. Cord blood offers clear advantages including easy collection, lower risk of viral transmission, reduced risk of graft versus host disease, and is storable as a frozen product, which means it is readily available without any long waiting times.
A growing number of new parents are opting to store their children's cord blood for potential future use. Insception houses the largest inventory of cord blood samples in Canada and is setting industry standards for quality in umbilical cord blood banking and stem cell research. Currently, public cord blood banking options are limited in Canada although considerable efforts are afoot to establish a national public cord blood bank. INSC01 provides an opportunity to extend the use of cord blood samples stored in both the private and public cord blood banks.
"Insception Biosciences is committed to remaining at the leading edge of stem cell research and cord blood banking to further advance stem cell treatments," says Joan Yates, President and COO at Insception Biosciences. "Every family should be made aware of the potential value of umbilical cord blood before the birth of their child so they can make an informed decision about their cord blood banking options."
Illustration: Microsoft clipart.
Insception News Release (02/06/08)
Pipeline Review (02/06/08)
China Stem Cells News (02/06/08)