Expanded access to Ossium HPC (deceased-donor bone marrow) for transplant
HPC Offered for PRESERVE Expansion
This program provides Ossium's deceased-donor bone marrow (HPC, Marrow) to people aged 12–80 who need an allogeneic bone marrow transplant but cannot join the PRESERVE protocol.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 12 Years to 80 Years |
| Sex | All |
| Sponsor | Ossium Health, Inc. Industry-sponsored |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT07145411 on ClinicalTrials.gov |
What this trial studies
This expanded-access program offers Ossium's HPC, Marrow—bone marrow recovered from deceased organ and tissue donors—to patients who are candidates for allogeneic transplant but cannot enroll in the PRESERVE protocol. Participating transplant centers will identify eligible patients (ages 12–80) whose treating physician judges that the potential benefit outweighs the risks, arrange product procurement, and proceed with transplantation according to local standard practice. The program is observational and focuses on providing access rather than testing a new therapeutic procedure, with outcomes and safety data collected as part of follow-up. Sites include University of Alabama at Birmingham, Henry Ford Health (Detroit), and The Ohio State University Medical Center (Columbus).
Who should consider this trial
Good fit: Ideal candidates are people aged 12–80 who are eligible for allogeneic bone marrow transplant for conditions such as ALL, AML, lymphomas, CLL, or CML and whose treating physician determines that potential benefit outweighs risk.
Not a fit: Patients younger than 12 or older than 80, those who are not candidates for allogeneic transplant, have contraindications to transplantation, or who can already access the PRESERVE protocol are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this program could increase access to compatible marrow grafts and enable more patients to receive potentially curative allogeneic transplants.
How similar studies have performed: Allogeneic bone marrow transplantation is an established treatment, but recovering marrow from deceased donors is a relatively new approach with limited long-term outcome data and is being explored in programs like PRESERVE.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients aged 12-80 may be eligible\* to receive bone marrow for transplantation through the Ossium HOPE Program if: Their treating physician determined they are eligible for allogeneic bone marrow transplant Their treating physician determined that the potential benefit outweighs the potential risks
Where this trial is running
Birmingham, Alabama and 3 other locations
- University of Alabama, Birmingham — Birmingham, Alabama, United States (Recruiting)
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
- The Ohio State University Medical Center — Columbus, Ohio, United States (Recruiting)
- Tristar Centennial Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Preethi Prasad, Senior Director Clinical Operations
- Email: preethi.prasad@ossiumhealth.com
- Phone: 415-513-5535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.