SBIR-STTR Award

Bone marrow represents a rich source of diverse stem, progenitor and other cells of clinical and research interest including hematopoietic stem cells (HSC) and mesenchymal stem cells (MSC), dendritic cells, T-cells, natural killer (NK) cells, B-cells and others. Currently, these cells are only recovered from living donors through bone marrow aspiration or peripheral blood mobilization. Ossium Health is developing the first clinical and research bank of bone marrow derived cells from deceased organ and tissue donors. While the concept of utilizing this resource for bone marrow cells was first described over 60 years ago, the ability to recover viable material efficiently and the infrastructure necessary to achieve this at even a modest scale simply has not existed. Ossium Health has overcome this by establishing a robust ecosystem comprised of a world-class tissue processor (and Phase III partner), major organ procurement agencies and innovation to, for the first time, allow recovery and banking of this plentiful source of potentially life-saving cells. However, for this bank to reach its full potential, further efficiencies must be advanced and implemented. This Phase I study aims to develop “smart baking” innovations by optimizing methods of cryopreserving intact marrow in situ within whole bones to allow time for infectious disease, sterility and, if required, HLA testing prior to investing in fully processing donor bones to isolate cellular components. This innovative work will also provide early guidance towards cryopreservation of more complex tissues such as vascular composite allografts (VCA). Additionally, this study will develop an enhanced method for recovering the initial target populations (HSC and MSC) which may increase efficiency by as much as 80% - drastically reducing cost and allowing more readily available and less expensive clinical grade and high-quality research material to be available to meet the growing demands of gene therapy, tissue engineering and basic science investigation.

Public Health Relevance Statement:
NARRATIVE Bone marrow is a rich source of many cell types with the potential to address numerous currently intractable diseases. Many studies have demonstrated the need for a large and genetically diverse source of these cells as well as the therapeutic benefits of minimally manipulating the cells before treating patients. Ossium Health has developed a robust system for obtaining living bone marrow cells from the 60,000 donors each year who gift tissues and organs following their death. Ossium is proposing to develop innovative methods that will reduce the costs of deceased donor bone marrow cell isolation, resulting in

Project Terms:
20 year old; Address; Adoption; Allografting; Animals; Aspirate substance; B-Lymphocytes; base; Basic Science; Blood Vessels; bone; Bone Banks; Bone Marrow; Bone Marrow Aspiration; Bone Marrow Cells; Bone Marrow Stem Cell; Bone Surface; Cadaver; Canis familiaris; Cell Count; Cell Separation; Cell Survival; Cell Transplants; cell type; Cells; Cellular Structures; Cessation of life; Clinical; Clinical Research; Collection; Communicable Diseases; Complex; Connective Tissue; cortical bone; cost; Cryopreservation; Dendritic Cells; Development; Digestion; Disease; Ecosystem; Flushing; Freezing; Future; gene therapy; Gifts; Health; Hematopoietic; Hematopoietic stem cells; Hospitals; Human; human leukocyte antigen testing; improved; In Situ; Industrialization; Infusion procedures; innovation; innovative technologies; interest; Investigation; Life; Living Donors; Manuals; Marrow; Mechanics; Medical Research; Mesenchymal; Mesenchymal Stem Cells; Methods; Modeling; Modification; Muscle; Natural Killer Cells; novel; novel strategies; Organ; Organ Donor; Organ Procurements; Particulate; Patients; Peptide Hydrolases; Perfusion; peripheral blood; Phase; phase 1 study; Physicians; Population; pressure; Process; Production; progenitor; Recovery; Research; Research Infrastructure; Research Personnel; Resources; Rodent; Safety; Savings; Science; soft tissue; Source; Specimen; stem; Stem cells; Sterility; Stromal Cells; substantia spongiosa; success; Surface; System; T-Lymphocyte; Target Populations; Technology; Testing; Therapeutic; Therapeutic Human Experimentation; Time; Tissue Donors; Tissue Engineering; Tissues; vertebra body; Work

Bone marrow represents a rich source of diverse stem, progenitor and other cells of clinical and research interest including hematopoietic stem cells (HSC) and mesenchymal stem cells (MSC), dendritic cells, T-cells, natural killer (NK) cells, B-cells and others. Currently, these cells are only recovered from living donors through bone marrow aspiration or peripheral blood mobilization. Ossium Health is developing the first clinical and research bank of bone marrow derived cells from deceased organ and tissue donors. While the concept of utilizing this resource for bone marrow cells was first described over 60 years ago, the ability to recover viable material efficiently and the infrastructure necessary to achieve this at even a modest scale simply has not existed. Ossium Health has overcome this by establishing a robust ecosystem comprised of a world-class tissue processor (and Phase III partner), major organ procurement agencies and innovation to, for the first time, allow recovery and banking of this plentiful source of potentially life-saving cells. However, for this bank to reach its full potential, further efficiencies must be advanced and implemented. This Phase II study aims to develop “smart baking” innovations by optimizing methods of cryopreserving intact marrow in situ within whole bones to allow time for infectious disease, sterility and HLA testing prior to investing in fully processing donor bones to isolate cellular components. This innovative work will also provide early guidance towards cryopreservation of more complex tissues such as vascular composite allografts (VCA). The resulting technology from this study may increase efficiency by as much as 80% - drastically reducing cost and allowing more readily available and less expensive clinical grade and high-quality research material to be available to meet the growing demands of gene therapy, tissue engineering and basic science investigation.

Public Health Relevance Statement:
NARRATIVE Bone marrow is a rich source of many cell types with the potential to address numerous currently intractable diseases. Many studies have demonstrated the need for a large and genetically diverse source of these cells as well as the therapeutic benefits of minimally manipulating the cells before treating patients. Ossium Health has developed a robust system for obtaining living bone marrow cells from the 60,000 donors each year who gift organs and tissues following their death. Ossium is proposing to develop innovative methods that will reduce the costs of deceased donor bone marrow cell isolation, resulting in <1/3 the cost and <1/5 the time to process each specimen. These life-saving and life-enhancing cells will be banked and made available to physicians and biomedical researchers for treating seriously ill patients and discovering new cures.

Project Terms:
Address; Adoption; Allografting; Aspirate substance; B-Lymphocytes; Basic Science; Biological Specimen Banks; Blood Banks; Blood Vessels; bone; Bone Banks; Bone Marrow; Bone Marrow Aspiration; Bone Marrow Cells; Bone Marrow Stem Cell; Bone Marrow Transplantation; Cadaver; Cell Separation; cell type; Cells; Cessation of life; Child; Clinical; Clinical Research; Clinical Trials; Communicable Diseases; Complement; Complex; cost; Cost Savings; Cryopreservation; Cryopreserved Cell; Dendritic Cells; Dimethyl Sulfoxide; Disease; Ecosystem; gene therapy; Generations; Genetic Variation; Gifts; Health; health disparity; Hematopoietic; Hematopoietic Stem Cell Transplantation; Hematopoietic stem cells; HLA Antigens; Hospitals; human leukocyte antigen testing; improved; In Situ; Industrialization; Infrastructure; Injury; innovation; interest; Investigation; Life; Living Donors; Manuals; Marrow; Mesenchymal Stem Cells; Methods; Minority; Modeling; Mus; Natural Killer Cells; novel; novel strategies; Organ; Organ Donor; Organ Procurements; Patients; peripheral blood; Phase; phase 2 study; Physicians; Procedures; Process; Production; progenitor; protective effect; Ramp; Recovery; Registries; Reproducibility of Results; Research; Research Personnel; Resources; Savings; Source; Specimen; stem; stem cells; Sterility; System; T-Lymphocyte; Technology; Therapeutic; Therapeutic Human Experimentation; Time; Tissue Donors; Tissue Engineering; Tissues; trial comparing; Umbilical Cord Blood; United States Health Resources and Services Administration; Vacuum; vertebra body; Woman; Work