BioLife Solutions CryoStor® Freeze Media Adopted by Parcell Laboratories for Stem Cells to be Studied in Clinical Trials
PR Newswire
BOTHELL, Wash.

BOTHELL, Wash., Feb. 25, 2014 /PRNewswire/ -- 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 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.  

Media & Investor Relations
Daphne Taylor
Senior Vice President, Chief Financial Officer
(425) 402-1400
dtaylor@biolifesolutions.com

SOURCE BioLife Solutions, Inc.

We believe the promise of cell and gene therapies starts with the integrity of a single cell

Advancing the future of cell and gene therapy

The human body can heal itself. Cell and gene therapies are designed to augment the patient’s ability to fight disease but only if the living cells behind those therapies remain viable and functional throughout the production processes. At BioLife Solutions, our mission is to protect the integrity of cells and provide trusted tools, services, and expertise that can enable our customers to advance the development and delivery of cell and gene therapies. We believe the future of cell and gene therapies hinges on the integrity of every single cell and we are here to protect that promise.

We understand the technical demands of bioprocessing in this field, and our advanced biopreservation expertise, cell culture optimization products, innovative storage systems, and closed-system manufacturing solutions are designed to enhance process efficiency, maintain cellular viability, and ensure reproducibility at every stage. Whether scaling up from R&D, navigating clinical trials or optimizing cryopreservation protocols for commercial production, we provide the tools and experience to streamline your workflow and safeguard your therapies.

Work with experts who understand your biopreservation challenges

Notch-Right-25px
Notch-Bottom-25px

Collaborative and comprehensive CDMO support

At BioLife Solutions, we partner with leading contract development and manufacturing organizations (CDMOs) to enhance their biopreservation and cell processing capabilities. By providing advanced tools, regulatory support, and process optimization strategies, we empower CDMOs to better serve therapy developers, ensuring quality, consistency, and scalability in cell therapy manufacturing.

Regulatory
readiness

Navigating the complex regulatory landscape of cell and gene therapy requires a proactive approach. BioLife Solutions offers experienced regulatory support to help prepare your biopreservation and cell processing methods to meet global standards. From IND and BLA submissions to compliance with GMP, FDA, and EMA guidelines, our solutions help streamline approval pathways.

Notch-Left-25px
Notch-Bottom-25px

STORE

CellSeal®
CryoCase

Alleviate CGT container challenges like fracture risk, bag burping or high rates of particulates

Notch-Right-25px
Notch-Bottom-25px

Data-driven
decision making

Stay ahead with our comprehensive Evidence Library, a curated collection of scientific publications, white papers, and case studies demonstrating the efficacy of BioLife Solutions’ technologies. Access peer-reviewed research, real-world application data, and expert insights to support your bioprocessing and regulatory strategies.

Insights

May 21, 2025

Designing the Ideal Cryostorage Container for CGT

April 18, 2025

The Cell Summit ’25: A Must-Attend Event for Innovators in Cell & Gene Therapy

March 27, 2025

Optimizing Biopreservation Strategies for Apheresis-Derived Cells in Immunotherapeutic Applications

February 19, 2025

How to prepare early for regulatory submissions from IND to BLA

Preserve, protect and expand cell performance

Mastering
Biopreservation

Ensure Regulatory Submission Readiness

Automate & Close
CGT Processes

Protect & Expand
Cell Performance