HPC Offered for PRESERVE Expansion

NCT07145411 | Recruiting

• 2 other identifiers: HOPE ProgramHOPE
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 4

Brief 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

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; Sickle cell anemia; Thalessemia

Outcome Measures

Primary Outcomes (1)

• Neutrophil engraftment

  1\. To determine cumulative incidences of neutrophil engraftment (ANC ≥500/µL for 3 consecutive values)

  28 days

Study Arms (1)

Ossium HPC, Marrow

Ossium HPC, Marrow will be provide for infusion on the day of transplant

Other: Bone Marrow Transplant with Ossium's HPC, Marrow (bone marrow recovered from deceased organ and tissue donors)

Interventions

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.

Ossium HPC, Marrow

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing allogenic bone marrow transplant

You may qualify if:

• 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

Sponsors & Collaborators

• Ossium Health, Inc.: lead

Study Sites (4)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Tristar Centennial Medical Center

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

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

Interventions

Bone Marrow Transplantation

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myeloproliferative Disorders; Bone Marrow Diseases; Anemia; Bone Marrow Failure Disorders; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Central Study Contacts

Preethi Prasad, Senior Director Clinical Operations

CONTACT

415-513-5535; preethi.prasad@ossiumhealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 28, 2025
• Study Start: June 27, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (4)