The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation
Official Title: Expanded Use of G-CSF Mobilized Donor CD34+ Selected Cells for Allogeneic Transplantation to Recipients With Limited Donor Engraftment
Study ID: NCT02258490
Brief 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.
Detailed Description: 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.
Minimum Age: 17 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
Name: Edmund Waller, MD, PhD
Affiliation: Emory University
Role: PRINCIPAL_INVESTIGATOR