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Transplantation medicine / Hematology / CD34 / Blood cells / Graft-versus-host disease / Cell biology / Hematopoietic stem cell / Cell therapy / Genous / Biology / Medicine / Stem cells


BH110018 CTGTAC Briefing Document CliniMACS CD34 Reagent System FDA BRIEFING DOCUMENT
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City

Munich / /

Company

Miltenyi / /

Continent

Europe / /

Country

Germany / United States / /

Event

FDA Phase / Product Issues / /

Facility

Blood Institute / /

IndustryTerm

treatment of acute myeloid leukemia / cell processing laboratory / pre-selection leukapheresis product / end user cell processing laboratory / cell selection device / heterogeneous leukapheresis product / cell processing data / monoclonal antibody-based selection systems / leukapheresis product / donor leukapheresis product / humanitarian use device / device manufacturer / /

MedicalCondition

leukemia / enteritis / recipient’s leukemia / Chronic GVHD / disease / skin rash / graft-vs-host disease / opportunistic infection / injury / diseases / disorder / Infection / illness / acute myelogenous leukemia / acute myeloid leukemia / /

MedicalTreatment

leukapheresis / Apheresis / Total Body Irradiation / /

Organization

Food and Drug Administration / Review Division / office of Cellular / FDA / Engineering Joint Accreditation Committee / Blood and Marrow Transplantation Foundation of Accreditation / Investigational New Drug Institutional Review Board International Society / National Heart Lung and Blood Institute / Gene Therapies Advisory Committee / Advisory Committee / Center for Biologics Evaluation and Research / Cellular Therapy International Society of Hematotherapy / American Association of Blood Banks / /

Person

Cord Hematopoietic Progenitor / Tissue Therapies / Gene Therapies / /

Product

CliniMACS / CliniMACS® CD34 Reagent System / HISTORY The CliniMACS® CD34 Reagent System / Investigational New Drug / device performance resulting / /

Technology

Chemotherapy / Transplantation / Stem Cells / ATG / /

SocialTag