Celavie Biosciences Awarded U.S. Patents for Stem Cell Technology with Applications for Central Nervous System Disorders
Novel cells offer functional and structural restoration advantages for transplantation and therapy
OXNARD, Calif., September 13, 2016—Regenerative medicine company Celavie Biosciences LLC, announced that the U.S. Patent and Trademark Office issued patents for its pluripotent stem cells with applications for a range of disorders of the central nervous system (CNS), including Parkinson’s disease.
The cells can be propagated and maintained for extended periods of time in culture in the absence of a feeder layer. They are useful for transplantation to hosts having disease and/or damage, particularly of the CNS, as they are capable of migrating to the sites in need of repair and of adopting a phenotype most appropriate to the nature of the damage or disease.
U.S. Patent No. 8,367,406, “Pluripotent cells,” expands on the discovery of an unexpected type of pluripotent cells (PCs) and a culture medium optimized for long-term growth of these cells, which express markers of both human neural progenitor cells (NPCs) and stem cells. PCs cultured in accordance with the invention are capable of surviving in vitro for longer than one year, and as long as three and a half years.
U.S. Patent No. 9,439,932, “Pluripotent cells,” provides PCs that are immunopositive for both the neural progenitor marker, nestin, and a pluripotent cell marker. The cells exhibit rapid doubling times and can be maintained in vitro for extended periods. Also provided are cell cultures containing the PCs, a method of transplanting human PCs to a host, and a method of reducing seizure activity in a subject.
The pluripotent nature of Celavie’s cells renders it unnecessary to genetically modify or predifferentiate the cells for transplant, and eliminates concerns about selecting the appropriate cell phenotype. The invention provides, in one embodiment, a substantially pure culture of PC that is free of genetically modified cells. Use of these PC provides advantages for transplantation and therapy over use of predifferentiated cells.
Celavie’s PCs have been successfully transplanted into the brain, providing restoration of structure and function in animal models of Parkinson’s and epilepsy. In addition, PCs implanted simultaneously with or shortly after the seizure-inducing lesion protect the brain from structural damage and prevent seizure activity.
“The technology originated with the theory that undifferentiated stem cells are able to react to the micro-environment into which they are injected and mature into multiple cell types dictated by their new surroundings,” said Celavie Executive Vice President and Chief Science Officer Oleg Kopyov, MD.
Using the latest technological breakthroughs, Celavie can produce large banks of undifferentiated cells with uniform qualities utilizing closed-system bioreactors. The cells are grown in a specialized medium that allows them to maintain their sterility and genetic stability over the course of the manufacturing process.
“Celavie addresses a large global medical need for which there are no effective treatments or cures,” said Celavie CEO and President Sandy Solmon. “The primary focus of our technology is to address the loss of function and devastation associated with Parkinson’s disease and other disorders of the central nervous system. Affecting one billion people and representing over six percent of the global burden of disease, neurological disorders present one of the greatest threats to public health, which will become even more devastating as populations rise.”