Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders

NCT03626285 | Unknown

• 3 other identifiers: IRB00010804NCI-2018-00556NCI-2020-02357
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Benign Neoplasm; Bone Marrow Transplantation Recipient; Hematopoietic Cell Transplantation Recipient; Malignant Neoplasm

Interventions

Bone Marrow Transplantation PROCEDURE

Undergo BMT

Also known as: BMT, Bone Marrow Grafting, Bone marrow transplant, Marrow Transplantation

CliniMACS CD34 Reagent System DEVICE

CD34 selection ex vivo

Peripheral Blood Stem Cell Transplantation PROCEDURE

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

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

AVAILABLE

MeSH Terms

Conditions

Neoplasms

Interventions

Bone Marrow Transplantation; Peripheral Blood Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation

Study Officials

• Eneida Nemecek, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eneida Nemecek, MD

CONTACT

503-494-0829; nemeceke@ohsu.edu

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: August 13, 2018
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

US (1)