Chapters authored
HyStem®: A Unique Clinical Grade Hydrogel for Present and Future Medical Applications
Medicine needs targeted, minimally-invasive delivery of protein-based and cell-based therapeutics to increase efficacy and reduce occurrence and severity of side effects. Local delivery requires a matrix to sequester and protect the medicine until its effect can be realized. The problem is, unlike stable small molecule drugs, proteins and cells cannot be co-packaged with a matrix in a prefilled syringe—they must be mixed with their matrix at the point of care. HyStem hydrogels fix this problem: They are arguably the first commercially available, GMP-qualified biodegradable hydrogels both with the ability to formulate with either proteins or cells in the hospital/surgical suite and with a history of safe use in humans. HyStem is designed to be protein, cell-friendly and in situ crosslinkable, permitting homogeneous mixing of therapeutics. One HyStem formulation is 510(k) cleared and another the subject of two European clinical trials. Key applications include localized delivery of therapeutic growth factors, antibodies, and cells. In the future, we envision HyStem’s flexibility and clinical use history forming the basis for a new generation of therapeutics. Two examples described here include HyStem’s use for patient-derived organoid culture to develop new drugs as well as for bioprinting to manufacture new organs.
Part of the book: Hydrogels