SBIR-STTR Award

The biopreservation of hematopoietic stem cells (HSCs) and bone marrow will allow for critical advances in healthcare, chemotherapy, and banking for mass casualty events. Cryopreservation is considered the answer, but remains a highly interdisciplinary problem that has yet to allow the successful full viability recovery of cells, tissues, and organs for on-demand applications. The use of cryoprotective agents (CPAs) like DMSO is hindered by their innate cytotoxicity and unfavorable effects in patients infused with DMSO containing HSCs. Opportunity lies in the development of a highly effective CPA or media system that significantly reduces or removes the use of harmful CPAs from cryoprotectant solutions. A cutting-edge preservation method and protocol is needed.Biomedical applications of hydrogels are ever growing with the advancement of antibiotic and traumatic wound care, time and location specific drug delivery, tissue engineering scaffolds, cell preservation, etc.X-Therma has engineered an advanced biomimetic cryoprotective matrix system for eventual use in bone marrow preservation. Phase I will focus on feasibility studies to assess the inherent cryoprotective effect of the matrix system. CD34+ cells will be encapsulated, subjected to a cryopreservation protocol and rewarming procedure. Simple cell assessment by live/dead and metabolic activity assays will be used to show feasibility.

A key bottleneck to be addressed in regenerative medicine is hypothermic preservation of cells and tissues, which has been shown to extend survival of cell and tissue-based therapies by decreasing ischemic effect. However, current preservation technology is aged, toxic and less effective than desired, hindering efforts to repair traumatic injury and chronic disease using new cell and tissue-based therapies. The proposed extracellular-like cryopreservation matrix technology (a cryomatrix) supports the critical preservation infrastructure needed to enable post-delivery assurance of therapy viability, function, and efficacy for precious biologics such as bone marrow.Phase I engineered first-of-its-kind biomimetic cryomatrices that are thermoresponsive and biocompatible to cryopreserve biologics. These non-toxic DMSO-, protein- and serum-free cryomatrices and the chemistry governing its high cell recovery performance after storage at -80C is made possible by bioinspired chemistry. A Phase II R&D effort will advance chemical efforts to extend the capabilities of these cryomatrices and maximize their technological impact in biobanking.The primary goal is to establish this technology for long-term storage of critical blood and tissue biologics. Cryopreserved, transported, and thawed biologics will be transplanted into an immunocompromised murine model and assessed for engraftment at various time points.