Bone Marrow Transplant (BMT)HOPENCT07145411
HPC Offered for PRESERVE Expansion
An observational study of Bone Marrow Transplant (BMT), run by Ossium Health, Inc. at 4 sites in United States.
Trial summary
Ossium recognizes that not all patients who could benefit from Ossium's HPC, Marrow can access the PRESERVE trial for logistical or eligibility reasons. The HOPE program is expanded access program to serve these patients by providing our bone marrow product Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Bone Marrow Transplant (BMT)
- What is being tested?
- Bone Marrow Transplant with Ossium's HPC, Marrow (bone marrow recovered from deceased organ and tissue donors)
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Jun 2024to Aug 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing allogenic bone marrow transplant
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Preethi Prasad, Senior Director Clinical Operations contact
United States4 sites, 4 recruiting
- Recruiting
University of Alabama, Birmingham
Birmingham, Alabama, 35294
Mary Underwood
- Recruiting
The Ohio State University Medical Center
Columbus, Ohio, 43210
Nicole Szuminski
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Kelly Walls
- Recruiting
Tristar Centennial Medical Center
Nashville, Tennessee, 37203
Angela Heine
About this study
Ossium recognizes that not all patients who could benefit from Ossium's HPC, Marrow can access the PRESERVE trial for logistical or eligibility reasons. The HOPE program is expanded access program to serve these patients by providing our bone marrow product
- Conditions
- Bone Marrow Transplant (BMT)
- Being tested
- Bone Marrow Transplant with Ossium's HPC, Marrow (bone marrow recovered from deceased organ and tissue donors)
- Keywords
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphomas, Chronic lymphoblastic Leukemia, Chronic Myeloid Leukemia, myelodysplastic syndrome, stem cell transplant, severe aplastic anemia, Sickle cell anemia, Thalessemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes, Anemia, Aplastic, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Transplant with Ossium's HPC, Marrow (bone marrow recovered from deceased organ and tissue donors)Other
The HOPE Program does not include any investigational drugs. The medicines and procedures in this program are standard of care for a transplant. Bone marrow cells from a deceased organ and tissue donor for use in your transplant is the only product offered to you by Ossium Health.
| Study group | Role | What they receive |
|---|---|---|
| Ossium HPC, Marrow | Ossium HPC, Marrow will be provide for infusion on the day of transplant Receives: Other: Bone Marrow Transplant with Ossium's HPC, Marrow (bone marrow recovered from deceased organ and tissue donors) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil engraftment
- To determine cumulative incidences of neutrophil engraftment (ANC ≥500/µL for 3 consecutive values)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start27 Jun 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow Transplant (BMT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ossium Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145411
- Sponsor's protocol ID
- HOPE Program
- Other IDs
- HOPE
- Acronym
- HOPE
- Status last verified
- Aug 2025
- First submitted
- 10 Jul 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No