Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation
Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation
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.
This is a single-arm, open label, single institution, compassionate study which will enroll
 patients who are marginally engrafted and transfusion and/or growth factors dependent after
 allogeneic hematopoietic stem cell transplant (HSCT) regardless of the underlying disease for
 which the transplant was performed. Study subjects will receive a "booster" infusion of CD34+
 cell selected and T-cell depleted G-CSF mobilized apheresis product from the original stem
 cell donor in order to improve engraftment. The "booster" infusion will be administered
 without prior conditioning.
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)

 -  HIV 1+2 antibodies

 -  Hepatitis C virus (HCV) antibodies

 -  Human T-lymphotropic virus (HTLV) I/II antibodies

 -  Rapid plasmin reagin (RPR)

 -  HIV-1 nucleic acid amplification test (NAT)

 -  HCV NAT

 -  West Nile virus (WNV)

 -  These tests will be obtained, and reported to Emory, within 30 days prior to
 collection of the CD34+ cell product.

 Recipient Inclusion Criteria:

 -  Only patients who are experiencing life-threatening hematological insufficiency,
 following an allogeneic hematopoietic stem cell transplant will be enrolled into this
 study

 -  Patient must be age > 17

 -  Must have ≥ 90% donor cells in the unfractionated peripheral blood based on either XY
 fluorescence in situ hybridization (FISH) or standard short tandem repeats (STR)

 -  More than 60 days post allogeneic stem cell transplantation and no reversible etiology
 found after an allogeneic stem cell transplantation

 -  Must meet one of the following criteria:

 -  Platelets < 20,000/μl, absolute neutrophil count (ANC) < 500/μl or

 -  Transfusion dependent for at least one cell line and/or

 -  On growth factor support (G-CSF) without adequate response for 30 days

 -  The original HSCT donor must be available, willing, and medically able to undergo
 G-CSF mobilization and the apheresis procedures

 -  Patients must have non-immune mediated graft dysfunction