Clinical trial · Expanded Access
Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders
Institutional Protocol of Bone Marrow Transplantation Using CD34-Selected Peripheral Blood Stem Cells From Related Haploidentical or Unrelated Donors for Treatment of Malignant and Nonmalignant Disorders
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Neoplasm | Benign Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Bone Marrow Transplantation Recipient | — | UNRESOLVED | — |
| Hematopoietic Cell Transplantation Recipient | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone Marrow Transplantation | Procedure | — | UNRESOLVED |
| CliniMACS CD34 Reagent System | Device | — | UNRESOLVED |
| Peripheral Blood Stem Cell Transplantation | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with malignant or nonmalignant diseases that can benefit from alternative stem cell transplantation according to institutional standard practice guidelines * Patients lacking a healthy human leukocyte antigen (HLA)-identical related donor and having one of the following alternative donor sources: * HLA-haploidentical related (HLA antigen genotypic match \>= 4/8 and \<= 7/8) or * Unrelated donor that is HLA matched at \>= 7/8 HLA antigen loci * The selected donor must also be: * Able to receive granulocyte colony-stimulating factor (G-CSF, filgrastim) and undergo apheresis either through placement of peripheral or temporary central venous catheter, based on institutional guidelines for peripheral blood stem cell collection * Meet all institutional standard criteria for clearance for peripheral stem cell collection * Recipients must meet institutional treatment standards based on pre-transplant evaluations including: * Adequate major organ functions * Free of major systemic infections * Not pregnant, if female of childbearing age (post-pubertal) * Recipient (if \>= 18 years) or their parent/legal guardian (if \< 18 years) must be able to sign the informed consent form for the treatment plan; assent will be obtained from recipients 7-17 years of age, in accordance to our institutional guidelines Exclusion Criteria: * Patients not meeting clearance criteria for bone marrow transplantation (BMT) based on standard institutional guidelines * Presence of anti-HLA antibodies against donor antigens in a recipient or anti-HLA antibodies against recipient antigens in a donor * Known allergy to murine (mouse) protein or iron-dextran
References
Publications (0)
Data not yet available