Hematologic Diseases
Expanding access to hematopoietic stem cell transplants for patients in need
Program
Phase 1
Phase 2
Phase 3
Commercial
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PRESERVE I Study
Phase 2
A first-in-human, multi-center, single-arm study of HLA-partially-matched allogenic cryopreserved deceased donor bone marrow to treat patients with hematologic malignancies. The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute leukemias. Patients will either receive myeloablative conditioning or reduced intensity conditioning regimen prior to the transplant. Patients will be followed for 56 days for safety endpoints and remain in follow-up for one year.
Related Products
HPC, Marrow
Partners
NMDP / Be the Match / CIBMTR
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Graft-versus-host Disease (GVHD)
Pre-Clinical
Evaluating the use of Ossium's mesenchymal stem cell product to treat steroid-refractory acute GVHD in adult and pediatric patients who previously had a hematopoietic cell transplantation (HCT) for acute leukemia and myelodysplastic syndromes
Related Products
MSCs
Organ Transplant Rejection
Allowing organ transplant recipients to lead healthy lives without immunosuppression
Program
Pre-Clinical
Phase 1
Phase 2
Phase 3
Commercial
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Multivisceral Transplantation
Phase 1
Phase 1 safety and feasibility clinical trial with the objective of inducing tolerance in intestinal transplant patients by establishing mixed Chimerism via infusion of Ossium’s selected CD34+ cells processed from the organ donor's bone marrow.
Related Products
Selected CD34+ Cells
Partners
Columbia University
Musculoskeletal Defects
Leveraging Ossium's cell therapy expertise to develop next-generation viable bone matrix allografts
Program
Pre-Clinical
Phase 1
Phase 2
Phase 3
Commercial
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OssiGraft™ Viable Bone Matrix Allografts
Commercial
OssiGraft™ and OssiGraft Prime™ are viable bone matrix allografts containing a formulation of viable cryopreserved cells in their native bone niche. OssiGraft™ and OssiGraft Prime™ are available in a variety of sizes and are intended for the repair, replacement, and reconstruction of musculoskeletal defects of the spine, pelvis, or extremities. These products are minimally manipulated HCT/Ps regulated by the FDA under section 361 of the Public Health Service Act and 21 CFR Part 1271 and do not require premarket authorization. Ossium Health complies with Good Tissue Practices and is an FDA-registered Tissue Establishment.
Related Products
OssiGraft™ Viable Bone Matrix
OssiGraft Prime™ Viable Bone Matrix