2/25/2014 11:35:22 AM
BOTHELL, WA — February 25, 2014 — BioLife Solutions, Inc. (OTCQB: BLFSD), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues (“BioLife” or the “Company”), today announced that Natick, Massachusetts-based Parcell Laboratories has adopted BioLife’s CryoStor clinical grade cell and tissue freeze media for use in future clinical trials of Early Lineage Adult (ELA) stem cell-potential therapies, for which Parcell holds an exclusive worldwide license.
On February 20th at the Global Technology Community Cell & Gene Therapy Conference, Colin White, Ph.D., Chief Scientific Officer at Parcell Laboratories, presented the following abstract on the discovery and clinical development of ELA cells:
“Synovial fluid from osteoarthritic knees (SF) has for some time been recognized as a rich source of adult stem cells (ASCs), and several studies have documented SF-derived ASC isolation and characterization. Previous immunophenotype analyses reveal that each cell population isolated from SF to date expresses a surface marker profile that includes positivity for at least some of CD13, CD44, CD73, CD90 (Thy-1), and/or CD105 (endoglin/SH2), suggesting that these cells may be classed as either mesenchymal stem/progenitor cells or multipotent adult progenitor cells, a subset of the MSC population. For the first time, we report here the isolation and characterization of a novel population of SF-derived ASCs, which we have termed Early Lineage Adult (ELA) Stem Cells. ELA cells do not detectably express CD34, CD44, CD45, CD73, CD90, CD105, and MHC Class I, but do express genes that are indicative of stemness including OCT4A, NANOG, and REX1. In vitro studies reveal that ELA cells differentiate into tissues of ectodermal, mesodermal, and endodermal origins, and in vivo studies demonstrate that ELA cells harbor a significant osteogenic differentiation capacity.
Clinically, an ELA cell-based therapy has been developed and used commercially in approximately 3500 surgical procedures for spinal fusion, and a retrospective chart review of treated patients revealed promising results, with detectable fusion as early as 6 months post-surgery and no attributable adverse events. The product is processed using Parcell’s proprietary protocol, cryopreserved (in BioLife Solutions CryoStor CS10), and delivered frozen to the operating room for surgical implantation. As ELA cells appear to proliferate extensively without loss of differentiation potential, and we have demonstrated that ELA cell-based therapies designed for clinical use can be produced, we suggest that ELA cells likely represent a novel source of stem cells for the potential treatment of numerous diseases.”
Pamela Layton, founder and CEO of Parcell Laboratories, remarked on the qualification and validation of CryoStor for use with ELA cells by stating, “Over the past several years, our data clearly demonstrated the superior preservation efficacy of CryoStor over traditional home brew and competing commercial freeze media products in several applications. We value our relationship with BioLife and their support and look forward to continuing to evaluate the potential of our technology in a number of clinical trials.”
Mike Rice, BioLife’s President & CEO, commented on Parcell’s adoption of CryoStor for potential new regenerative medicine clinical trials and potential treatments for by stating, “We have a long and very positive history with the management team at Parcell Labs and are delighted to support their use of our products in several very promising new clinical applications. With our products now used in well over 100 hospital-approved and clinical trial stage cell and tissue-based applications, BioLife is clearly poised to capitalize on the growth of the regenerative medicine market. ”
About Parcell Laboratories
Parcell Laboratories, Inc., founded in 2008, develops novel therapeutics based on its patented adult stem cell platform technology, the ELA® cell. The ELA cell was discovered by scientists affiliated with the Brigham and Women's Hospital and Harvard Medical School, who demonstrated the vast potential of the technology in regenerative medicine. ELA cells are found in various tissues throughout the body and are characterized by a specific surface marker profile that set them apart from other adult stem cells. Based in Natick, Mass., the company's state-of-the-art research, processing, storage and fulfillment facilities set the stage for the future of adult stem cells and regenerative medicine. For more information, visit www.parcelllabs.com. Parcell Laboratories is a member of the Parcell Group of companies, which also includes CellCure Trust, LLC., Cellogx, LLC. and Parcell Spine, LLC.
About BioLife Solutions
BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. The Company’s proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife’s biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. BioLife’s enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.
This news release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements include any statements that relate to the intent, belief, plans or expectations of the Company or its management, or that are not a statement of historical fact. Any forward-looking statements in this news release are based on current expectations and beliefs and are subject to numerous risks and uncertainties that could cause actual results to differ materially. Some of the specific factors that could cause BioLife Solutions’ actual results to differ materially are discussed in the Company’s recent filings with the Securities and Exchange Commission. BioLife Solutions disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
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