NO_LONGER_AVAILABLENot Applicable

Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation

United States

Plain-language summary

Allogeneic hematopoietic stem cell transplantation (HSCT) is an established form of treatment for hematological abnormalities. Poor graft function, occurs when there poor donor engraftment. A second infusion of unselected donor hematopoietic stem cells (HSC) can result in improvement, but can potentially increase the incidence of graft versus host disease. Cluster of differentiation 34+ (CD34+) selected stem cells depleted of T-cells is an attractive alternative for treatment of poor graft function as it may be associated with less Graft versus Host Disease (GVHD) and enhanced count recovery. The investigators are using the Miltenyi CliniMACS device and CD34 cell selection reagents for the preparation of allogeneic hematopoietic progenitor cell (HPC) transplants for patients who have had prior stem cell transplants and require a stem cell "boost" from the original donor.

Who can participate

Age range17 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Donor Inclusion Criteria: * Donors must be eligible and approved for a hematopoietic stem cell graft according to institutional criteria (related donor) or NMDP criteria (volunteer unrelated donor) * Donors must be ≥ 17 years old and ≤ 75 years old * Donors must be agreeable to receive G-CSF for CD34 cell mobilization and undergo apheresis for the second donation of peripheral blood mononuclear cells (PBMC) * Donor must have adequate peripheral venous catheter access for apheresis or must agree to placement of a central catheter * The following laboratory tests/evaluations will be performed for all donors registered in the study. Additional evaluations/studies may also be performed by the site as dictated by the donor's clinical situation or standard practice for monitoring normal donors * History and physical examination * Automated complete blood count (WBC, red blood cells \[RBC\], hematocrit, hemoglobin) with differential and platelet counts * Serum chemistries panel including electrolytes, glucose, blood urea nitrogen (BUN), alanine aminotransferase (ALT), creatinine, bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH) and albumin. Electrolytes to include sodium, potassium, chloride, carbon dioxide, calcium and magnesium. * Infections disease titers by FDA licensed tests for: * Cytomegalovirus (CMV) antibody * Hepatitis panel (Hepatitis B including HBsAg, HBcAb \[immunoglobulin M {IgM} and immunoglobulin G {IgG}\]; hepatitis C antibody) * …

Trial details

NCT IDNCT02258490

SponsorEmory University

Sponsor typeOTHER

Study typeEXPANDED_ACCESS