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Could dead donors provide Life-Saving bone marrow?

NCT ID NCT05589896

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times

Summary

This early study is testing whether bone marrow from deceased donors can be safely used for transplants in people with blood cancers like leukemia and lymphoma. Twelve patients will receive the transplant along with chemotherapy or radiation. The main goal is to see if the new marrow starts making blood cells and to check for serious side effects over the first year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bone marrow from a deceased donor
What this could lead to
If successful, this could provide a new source of bone marrow for transplants, potentially helping more patients with blood cancers who lack a living donor.
What could go wrong
This is a very early, small trial (12 people) focused on safety. The approach may fail to engraft or cause serious side effects, and it's unknown if it will work as well as standard living-donor transplants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements * Male or female, aged ≥18 and ≤65 years for patients receiving MAC (Regimen A or Regimen B); aged ≥18 and ≤75 years for patients receiving RIC (Regimen C or D) * Patient must require allogeneic HCT per the discretion of the treating physician * Patient must be high-resolution, HLA partially or fully matched (4-8/8 allele matched at HLA-A, -B, -C, DRB1) to an available Ossium HPC, Marrow product * Stated willingness to comply with all study procedures and availability for the duration of the study * Diagnosed with malignant hematologic disease including: 1. Acute leukemia \[acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)\], MDS without fibrosis, or chronic leukemia (CLL, CML) in the first remission or beyond with ≤5% marrow blasts documented by bone marrow assessment and no circulating blasts or extra-medullary disease within 42 days prior to anticipated start of conditioning 2. Chemosensitive non-Hodgkin's lymphomas, Hodgkin's lymphoma, or cutaneous T cell lymphomas in the first remission or beyond documented by PET/CT imaging and bone marrow assessment within 42 days prior to anticipated start of conditioning * Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC) * HCT comorbidity index (HCT-CI) ≤5 * Adequate organ function defined as: 1. Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC) 2. Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected for hemoglobin. 3. Hepatic: total bilirubin ≤2.0 mg/dL, and ALT, AST, and ALP \<3 x upper limit normal (ULN), unless ALT, AST, and/or ALP are disease related 4. Renal: SCr within 1.5x normal range for age. If SCr is outside normal range for age, CrCl\> 60 mL/min/1.73m2 must be obtained (measured by 24-hour urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR) Exclusion Criteria: * Availability of suitable graft from living donor (defined as 7/8 or 8/8 HLA-matched related or unrelated donors, haploidentical donors, or cord blood donors) * Prior autologous or allogeneic HCT * Pregnancy or lactation * Ongoing treatment with an investigational drug used for disease-related treatment within 5 half-lives of the drug * Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings * Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Emory University - Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Henry Ford Cancer Institute

    Detroit, Michigan, 48202, United States

  • Methodist Hospital, Texas Transplant

    San Antonio, Texas, 78229, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • St. David's South Austin Medical Center

    Austin, Texas, 78745, United States

  • TriStar Bone Marrow Transplant

    Nashville, Tennessee, 37203, United States

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.