Ossium treats first leukemia patient in frozen bone marrow trial

Ossium Health, a US-based bioengineering firm, has conducted its first bone marrow transplant using cryopreserved bone marrow from deceased organ donors as part of its HOPE clinical program. This innovative approach aims to provide timely and accessible transplants for patients suffering from blood-related conditions like leukemia and lymphoma.

The standard procedure for bone marrow transplants typically involves harvesting healthy stem cells from the blood or bone marrow of a live, compatible donor, usually a family member. However, Ossium’s method utilizes cryopreserved bone marrow, which can be stored and shipped immediately as needed. This eliminates the often lengthy process of finding and securing a suitable graft from a live donor, which is particularly beneficial for patients with aggressive and high-risk malignant diseases.

Kevin Caldwell, CEO of Ossium Health, highlighted the critical need for a more accessible bone marrow transplant option. "Every year, 18,000 patients in the US are diagnosed with life-threatening illnesses where a bone marrow transplant is their best treatment option. However, nearly 9,000 of these patients are unable to receive a transplant," Caldwell stated. He emphasized that Ossium’s cryopreserved bone marrow offers a vital complement to existing sources, enhancing donor accessibility, particularly for underserved patients.

The first patient treated under this program was a 68-year-old diagnosed with acute myeloid leukemia. The transplant, conducted at Henry Ford Health in Detroit, Michigan, showed promising results. Doctors noted neutrophil engraftment by day 16 and platelet engraftment by day 21 post-transplant, with no adverse events related to the product reported so far.

Ossium’s bone marrow bank also aims to address the needs of patients with the lowest matching rates through the living donor registry, including racial and ethnic minority groups. Caldwell pointed out that the diverse racial and ethnic composition of the US donor pool uniquely positions Ossium’s bone marrow bank to serve patients globally, including those in countries where living donor registries are lacking.

The PRESERVE I study, also known as NCT05589896, is a Phase I/II trial designed to assess the safety and effectiveness of organ donor-derived bone marrow in patients with hematopoietic malignancies. Based in San Francisco, Ossium Health also operates the HOPE program to facilitate access to stem cells without requiring trial enrollment, further expanding the reach of this potentially life-saving treatment.

Caldwell believes that this innovative platform has the potential to revolutionize bone marrow transplants, making them significantly more accessible to underserved populations worldwide. He concluded, “Our bone marrow bank represents a major advancement in transplant medicine, providing a critical resource for patients both in the US and internationally, especially in countries where access to living donor registries is limited.”

With its groundbreaking approach, Ossium Health is poised to make a significant impact on the field of bone marrow transplantation, offering hope to thousands of patients who previously had limited treatment options.