An expanded access record providing Bone Marrow Transplantation and CliniMACS CD34 Reagent System in Benign Neoplasm, Bone Marrow Transplantation Recipient and Hematopoietic Cell Transplantation Recipient, sponsored by OHSU Knight Cancer Institute. Available at 1 site in United States. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by OHSU Knight Cancer Institute · Expanded access
This expanded access protocol studies bone marrow transplantation using CD34-selected stem cells from related or unrelated donors in treating participants with cancer or other disorders. Stem cells collected from the donor will be processed using a new device called CliniMACS CD34 Reagent System which marks the blood cells collected from the donor with a special protein called "antibody" that tags only the donor stem cells, sorting out other cells of the blood and immune system. This is done to remove, at least partially, some of the T cells. T cells are the cells in the blood that work as scavengers of the immune system deciding what belongs and what does not. These cells can sometimes cause rejection of the donor graft or a condition called graft-versus host disease (GVHD), where the donor cells can attack the body of the recipient. A bone marrow transplantation using CD34-selected stem cells may reduce the risk of these unwanted side effects of transplant as much as possible.
PRIMARY OBJECTIVES:
I. To provide a source of CD34-selected stem cells for patients with malignant and nonmalignant disorders undergoing bone marrow transplantation from haploidentical (human leukocyte antigen [HLA]-mismatched) related donors or HLA-compatible unrelated donors
SECONDARY OBJECTIVES:
I. Monitoring the safety of the CD34-selected stem cells for the recipient, as measured by adverse events related to stem cell infusion, incidence of engraftment of neutrophils and platelets, incidence of acute and chronic GVHD, and one year overall survival, disease-free survival, and primary disease recurrence.
OUTLINE:
Donor stem cells undergo CD34 selection ex vivo using the CliniMACS CD34 Reagent System using standard operating procedures (SOPs) from the manufacturer. Recipients undergo standard of care preparative regimen, bone marrow transplantation with CD34-selected peripheral blood stem cells via infusion over 1 to 2 hours on day 0, and then receive standard of care GVHD prophylaxis.
After completion of study treatment, recipients are followed up at least once weekly while inpatient until transplant day 100, every 1-3 months for the first year and yearly thereafter.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
Browse Neoplasms studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients lacking a healthy human leukocyte antigen (HLA)-identical related donor and having one of the following alternative donor sources:
The selected donor must also be:
Recipients must meet institutional treatment standards based on pre-transplant evaluations including:
Exclusion Criteria:
Undergo BMT
Also known as: BMT, Bone Marrow Grafting, Bone marrow transplant, Marrow Transplantation
CD34 selection ex vivo
Receive CD34-selected peripheral blood stem cells from related or unrelated donors
Also known as: PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplant, Peripheral Stem Cell Transplantation
Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.
Contact the providerGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
OHSU Knight Cancer Institute