RecruitingPhase 1Phase 2NCT05589896

A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies


Sponsor

Ossium Health, Inc.

Enrollment

12 participants

Start Date

Aug 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. Patients will either receive myeloablative conditioning or reduced intensity conditioning regimen prior to the transplant. Patients will be followed for 56 days for safety endpoints and remain in follow-up for one year.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether bone marrow from deceased donors can be used for bone marrow transplants in people with blood cancers. Currently, most transplants use living donors, but this approach could expand access for patients who cannot find a suitable living match. **You may be eligible if...** - You are 18–65 years old (or up to 75 for a less intense transplant regimen) - You have a blood cancer that requires a bone marrow transplant - You do not have a suitable living donor (related or unrelated) - The deceased donor bone marrow matches at least 4 out of 8 key immune markers (HLA) **You may NOT be eligible if...** - A suitable living donor is available - You have had a prior bone marrow or stem cell transplant - You are pregnant or breastfeeding - You have an active, uncontrolled infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROssium HPC Marrow, Bone Marrow Transplant

Hematopoetic Cell Transplantation

OTHERPre-transplant conditioning - Myeloablative (MAC)

Regimen A or Regimen B

OTHERPre-transplant conditioning - Reduced Intensity (RIC)

Regimen C or Regimen D

OTHERPost-transplant treatment

Post-transplant treatment


Locations(9)

City of Hope

Duarte, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University - Winship Cancer Institute

Atlanta, Georgia, United States

Henry Ford Cancer Institute

Detroit, Michigan, United States

Oregon Health and Science University

Portland, Oregon, United States

TriStar Bone Marrow Transplant

Nashville, Tennessee, United States

St. David's South Austin Medical Center

Austin, Texas, United States

Methodist Hospital, Texas Transplant

San Antonio, Texas, United States

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT05589896


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