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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPC Offered for PRESERVE Expansion
- ClinicalTrials.gov ID
- NCT07145411
- Acronym / sponsor ID
- HOPE / HOPE Program
- Conditions
- Bone Marrow Transplant (BMT)
- Keywords
- Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Lymphomas, Chronic lymphoblastic Leukemia, Chronic Myeloid Leukemia, myelodysplastic syndrome, stem cell transplant, severe aplastic anemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ossium Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ossium HPC, Marrow | – | Other: Bone Marrow Transplant with Ossium's HPC, Marrow (bone marrow recovered from deceased organ and tissue donors)Ossium HPC, Marrow will be provide for infusion on the day of transplant |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing allogenic bone marrow transplant
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow Transplant with Ossium's HPC, Marrow (bone marrow recovered from deceased organ and tissue donors)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. | Other | Ossium HPC, Marrow |
Primary outcome
Neutrophil engraftment
Time frame: 28 days
1. To determine cumulative incidences of neutrophil engraftment (ANC ≥500/µL for 3 consecutive values)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Preethi Prasad, Senior Director Clinical Operations contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Transplant (BMT), run by Ossium Health, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Preethi Prasad, Senior Director Clinical Operations (415-513-5535, preethi.prasad@ossiumhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil engraftment (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.