HPC, Marrow deceased donor bone marrow transplantation
undiscloseddrug program · high · Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Provide cryopreserved deceased donor-derived bone marrow for allogeneic transplantation in patients with hematologic malignancies, including acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas.
Allogeneic transplantation using HLA-partially to fully matched cryopreserved deceased donor bone marrow after myeloablative or reduced-intensity conditioning.
First-in-human clinical trial published in supplied records on 2024-08-16; related 2026 clinical publication reports engraftment and chimerism in mismatched allogeneic transplantation.
A 2026 publication reports three high-risk acute myeloid leukemia patients received 4/8 HLA-matched cryopreserved grafts with PTCy prophylaxis; all achieved neutrophil and platelet recovery with full donor chimerism, no relapse or chronic GVHD observed, and one death unrelated to the graft.
HOPE expanded access program for HPC, Marrow
undiscloseddrug program · high · Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time)
Provide Ossium's HPC, Marrow bone marrow product to patients who could benefit but cannot access the PRESERVE trial for logistical or eligibility reasons.
Expanded access program providing deceased donor-derived bone marrow product outside the PRESERVE trial.
Expanded access clinical record published in supplied records on 2024-06-27.
OSSM-001 for steroid-refractory acute GVHD
undiscloseddrug program · high · Mon Jun 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Treat steroid-refractory acute graft-versus-host disease with Ossium's mesenchymal stem cell product.
Clinical study of a single-dose infusion of Ossium MSCs product OSSM-001 to evaluate safety and feasibility.
Clinical study record published in supplied records on 2023-06-05.
Cryopreserved MMUD bone marrow with PTCy for hematologic malignancies
undiscloseddrug program · high · Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Assess safety and efficacy of deceased mismatched unrelated donor cryopreserved bone marrow transplantation for hematologic malignancies.
Multicenter single-arm study using cryopreserved bone marrow from deceased MMUD donors with PTCy, sirolimus, and MMF for GVHD prophylaxis.
Clinical trial record published in supplied records on 2022-09-01.
OSSM-001 for refractory perianal fistula in Crohn's disease
phase 1drug program · high · Mon Aug 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate bone marrow-derived MSCs as a treatment for refractory perianal fistulas in the setting of Crohn's disease.
Double-blind randomized Phase I safety study of a single injection of 100 million or 300 million bone marrow-derived MSCs versus placebo in 16 patients.
Phase I clinical trial record published in supplied records on 2022-08-01.
Mesenchymal stem/stromal cell potency assay matrix
exploratoryplatform · high
Ensure quality and consistency of clinical MSC products and support clinical translation by demonstrating comparability between MSC donors and manufactured lots.
Potency assay matrix evaluating T cell suppression, macrophage polarization, regulatory T cell induction, monocyte/macrophage chemoattraction, secreted immunoregulatory molecules, IDO1 activity, and extracellular vesicle effects.
2026 publication reports development and validation of the potency assay matrix for clinical MSC manufacturing.
The supplied abstract reports that bone marrow-derived MSCs consistently suppressed T cell proliferation, induced regulatory T cell differentiation, polarized monocytes into anti-inflammatory M2 macrophages, and demonstrated predicted in vitro functionality across MSCs from 10 donors.
Organ donor hematopoietic stem cell engraftment research
preclinicalresearch program · high
Demonstrate that hematopoietic stem cells from organ donors can support long-term multi-lineage engraftment.
Preclinical engraftment research using organ donor-derived hematopoietic stem cells in NSG mice.
2026 publication titled 'Hematopoietic stem cells from organ donors lead to long-term multi-lineage engraftment in NSG mice.'
The title and supplied publication listing indicate long-term multi-lineage engraftment in NSG mice using hematopoietic stem cells from organ donors.
OssiGraft viable bone matrix allografts
undiscloseddrug program · medium
Address musculoskeletal defects using viable bone matrix allografts.
Viable bone matrix allograft products listed in the pipeline, including OssiGraft Viable Bone Matrix and OssiGraft Prime Viable Bone Matrix.
Listed in Ossium's supplied pipeline as OssiGraft Viable Bone Matrix Allografts, OssiGraft Viable Bone Matrix, and OssiGraft Prime Viable Bone Matrix.
