No Mortality or Toxicity Noted With CryoStor Deployed as Vehicle Solution for Cells and Placebo in Direct Intramyocardial Injections
BioLife Solutions, Inc., 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”), recently announced its CryoStor cell freeze media was utilized in a porcine animal study of umbilical cord blood-derived mononuclear cells (UBC-MNC) to evaluate the safety and feasibility of these cells for cardiac regeneration in pediatric congenital heart disease (CHD).
The safety and feasibility study was performed at the Mayo Clinic in Rochester, Minnesota, with the results recently published in an article titled Safety and Feasibility for Pediatric Cardiac Regeneration Using Epicardial Delivery of Autologous Umbilical Cord Blood-Derived Mononuclear Cells Established in a Porcine Model System, which appeared in the peer reviewed clinical journal Stem Cells Translational Medicine.
Umbilical cord blood-derived mononuclear cells were frozen in protein-free, serum-free CryoStor CS10, containing 10% dimethyl sulfoxide (DMSO). Thawed cells were administered to piglets via intramyocardial injections, with follow up extended to three months. CryoStor CS10 was also used as the placebo control solution without cells, which was injected into randomized piglets.
The authors observed no mortality or toxicity in any study animals and concluded:
- “To date, no large clinical trials have been reported using any type of stem cells to augment CHD management in the pediatric setting.”
- “… there are no long term safety studies that have investigated the comprehensive profile of UCB-MNC transplantation into juvenile cardiac tissue recapitulating the pediatric setting.”
- “… this clinical-grade pipeline has now established the baseline safety profile of autologous UCB-MNC that demonstrates no measurable toxicity attributable to cell-based cardiac regenerative strategies within the innate physiological challenges of a juvenile/pediatric heart.”
- “The safety profile establishes the foundation for cell-based therapy directed at the RV of juvenile hearts and aims to accelerate cell-based therapies toward clinical trials for CHD.”
Mike Rice, BioLife President & CEO, stated, “The data from this study further support the use of our proprietary biopreservation media products in clinical applications. We are quite pleased to have an institution as renowned as the Mayo Clinic evaluate and use our products in their important clinical research.”
BioLife management estimates that the Company’s CryoStor cryopreservation freeze media andHypoThermosol storage and shipping media have been incorporated into the manufacturing and clinical delivery protocols of more than 175 cell and tissue-based regenerative medicine clinical trials for new products and therapies.
About BioLife Solutions
BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. 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, visit www.biolifesolutions.com.