Hpc Offered for Preserve Expansion

Study on the Use of Investigational Bone Marrow for Transplantation

J
Jodi Skiles

Primary Investigator

Enrolling By Invitation
12 years - 80 years
All
Phase N/A
1 participants needed
2 Locations

Brief description of study

Ossium produces cryopreserved hematopoietic progenitor cell bone marrow (HPC, Marrow (Cryopreserved)) recovered from deceased organ donors using good manufacturing practice (GMP) processing, Ossium’s HPC, Marrow (Cryopreserved) is supplied in units suitable for transplantation by infusion, the same procedure used for transplantation of other sources of HPCs, such as live donor BM aspirates, live donor apheresis products, or cord blood. 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 to patients undergoing allogenic bone marrow transplants.

Only eligible patients that have been referred by a physician or self-referred to and seen by section of Pediatric Stem Cell Transplant staff will be invited to participate in this program. The subject and donors are known to the study team and they have already been in contact regarding this treatment.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at Indiana University Simon Comprehensive Cancer Center (IUSCCC), please contact the
IU Clinical Trials Office at 
Phone: (317) 278-5632

Detailed description of study

Ossium’s HPC, Marrow (Cryopreserved) provides an “on-demand”, ready to use source of hematopoietic cell graft and enable a rapid treatment for patients without available living donors. HPC, Marrow (Cryopreserved) will expand access to life saving hematopoietic cell transplantation to individuals comprising the expanding racially and ethnically diverse populations in the USA. Furthermore, the Ossium HPC, Marrow (Cryopreserved) bank would reduce the interval between diagnosis and time to transplant, which is a critical factor for post-transplant outcomes

A patient that receives Ossium HPC, Marrow as a part of the HOPE program will be followed as per standard follow up based on institutional practices. Information on GVHD, relapse, serious adverse events and adverse events will be collected for up to two years post transplant.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bone Marrow Transplant (BMT), Hematopoietic cell transplantation, Cancer, Riley
  • Age: 12 years - 80 years
  • Gender: All

Inclusion Criteria:

  • 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

This study investigates the use of investigational cryopreserved bone marrow for transplantation. The purpose is to provide a ready-to-use source of hematopoietic cell grafts for patients who do not have available living donors. Hematopoietic progenitor cells (HPCs) are special cells that can develop into different types of blood cells. This study uses HPCs collected from deceased organ donors, which are then preserved and made ready for use.

Participants will receive the investigational cryopreserved bone marrow through a process called infusion, which is similar to other bone marrow transplant procedures. After the transplant, information on graft-versus-host disease (GVHD), relapse, and any adverse events will be collected for up to two years to monitor the outcomes and safety of the treatment.

  • Who can participate: Patients aged 12 to 80 who have been deemed eligible for allogeneic bone marrow transplant by their physician may participate. Participants must be referred by their physician or can self-refer and will be seen by specific staff as part of the enrollment process. The potential benefit must outweigh the potential risks as determined by their treating physician.
  • Study details: Participants will receive a bone marrow transplant using investigational cryopreserved cells. Information on GVHD, relapse, and adverse events will be collected for up to two years. Follow-up will be conducted according to standard institutional practices to monitor for any side effects or complications.
Updated on 25 Feb 2026. Study ID: PHO-OSSIUM-HOPE, 30332
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only