CellSeal closed-system cryogenic vial
Credit: COOK Regentec
SBIR Success Stories
NHLBI Small Business program supported development of new stem cell preservation technologies

Stem cell preservation enables advances in regenerative medicine

Regenerative medicine offers the promise of harnessing the body’s own resources to heal itself. Stem cells, which can be programmed to grow into a variety of cell types, are at the heart of regenerative medicine. Scientists are working on a variety of methods that involve using stem cells to repair or replace human tissues ravaged by disease. And for a few rare diseases, such as severe combined immunodeficiency, stem cell-based therapies have advanced enough to be considered curative. 

However, to remain viable, stem cells must be preserved under stringent conditions.  The cells must be stored in a sterile environment at low temperatures using materials that won’t damage them.  

General BioTechnology develops stem cell storage technologies with NHLBI support 

CellSeal closed-system cryogenic vial
This CellSeal closed-system cryogenic vial is designed to store stem cells and protect them from exposure to harmful contaminants. Photo source: COOK Regentec

This CellSeal closed-system cryogenic vial is designed to store stem cells and protect them from exposure to harmful contaminants. Photo source: COOK Regentec

Former Indiana University School of Medicine investigators Erik J. Woods and John K. Critser founded General BioTechnology in 1997. The company sought to address the growing need for technology to isolate stem cells and keep those cells alive for medical use. 

General BioTechnology received five grants from the National Heart, Lung, and Blood Institute (NHLBI) Small Business Innovation Research (SBIR) program from 2000 to 2009 to develop a novel system for safely preserving and storing stem cells. The resulting CellSeal vial allows stem cells to be loaded and sealed in a closed system to prevent contamination; stored safely at low temperatures; and thawed and recovered for clinical use.

CellSeal is currently being used in clinical trials to preserve stem cells used in investigational therapies for patients with cancer, blood, and immune system disorders.

Device manufacturer COOK Medical acquired General BioTechnology in 2012.  Reincorporated as COOK Regentec, the company is now the regenerative medicine arm of COOK Medical.

“Before we applied for the SBIR grants, we were in need of a packaging system, entirely closed to contamination, to store stem cells at cryogenic temperatures. Nothing like that existed. The SBIR program was great because we were able to get funding that allowed us to make prototypes and do initial testing. We wouldn’t have had either of these two things without the grants. The end product is now being used in clinical trials globally.”

 – Dr. Erik J. Woods, Co-founder of General BioTechnology        


The NHLBI Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs support research and development on the next generation of commercially promising technologies and products to prevent, diagnose, and treat heart, lung, blood, and sleep-related diseases and disorders. For more information on NHLBI’s small business programs, visit http://www.nhlbi.nih.gov/research/funding/sbir/about-program.htm

Disclaimer

Reference to any specific commercial products, process, service, manufacturer, and/or company does not constitute an endorsement or recommendation by the National Heart, Lung, and Blood Institute (NHLBI), the NHLBI's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, or any other portion of the U.S. Government.