Ossium Health has announced the treatment of its first leukemia patient using cryopreserved bone marrow derived from an organ donor, marking a significant step in its HOPE clinical program. This approach aims to address the critical shortage of matched bone marrow donors and improve accessibility to life-saving transplants for patients with blood-related conditions.
The patient, a 68-year-old diagnosed with acute myeloid leukemia, received the infusion at Henry Ford Health in Detroit, Michigan. Early results are promising, with doctors observing neutrophil engraftment by day 16 and platelet engraftment by day 21 post-transplant. No product-related adverse events have been reported to date.
Addressing the Bone Marrow Transplant Gap
Kevin Caldwell, CEO of Ossium Health, highlighted the urgent need for alternative bone marrow sources. "Every year, 18,000 patients in the US are diagnosed with life-threatening illnesses where a bone marrow transplant is their best treatment option, but nearly 9,000 of these patients are unable to receive a transplant," Caldwell stated. Ossium's cryopreserved bone marrow bank aims to complement existing sources and improve donor accessibility, particularly for underserved patients.
Traditional bone marrow transplants rely on finding a matching living donor, often a close relative. This process can be time-consuming and challenging, especially for patients from racial and ethnic minority groups who have lower matching rates in living donor registries. Ossium's approach eliminates the need for a donor search and allows for immediate shipment of cryopreserved bone marrow on demand.
The PRESERVE I Trial and HOPE Program
The treatment is being evaluated in the PRESERVE I (NCT05589896) study, a Phase I/II trial assessing the safety and effectiveness of organ donor-derived bone marrow in patients with hematologic malignancies. In addition to the trial, Ossium's HOPE program provides access to the stem cells outside of the clinical trial setting.
Global Implications
Ossium's bone marrow bank has the potential to serve patients globally, including those in underserved countries lacking living donor registries. "Since the US is a nation of immigrants from all over the world, the racial and ethnic makeup of our US-based bone marrow bank is uniquely positioned to supply the rest of the world," Caldwell added.
This innovative platform could revolutionize transplants, making them dramatically more accessible to underserved populations worldwide.
