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Cord blood bank / Cord blood / Center for International Blood and Marrow Transplant Research / Cell therapy / National Marrow Donor Program / Hematopoietic stem cell transplantation / Graft-versus-host disease / Myelodysplastic syndrome / CD34 / Biology / Medicine / Stem cells


CDER Clinical Review Template
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Company

HPC-A HPC-M HSCT Kg / LifeSouth Community Blood Centers Inc. / EXECUTIVE SUMMARY LifeSouth Community Blood Centers Inc. / /

Facility

Duke University / /

IndustryTerm

cord blood processing technology / cord blood product / treatment for certain diseases / cord blood banks / manufacturing / /

MedicalCondition

malignant and nonmalignant disorders / Disease / certain diseases / HCV / G Veno-occlusive Disease/Sinusoidal Obstructive Syndrome / diseases / host disease HbsAg Hepatitis B / disorders / /

MedicalTreatment

cell therapy / /

Organization

Duke University / Biological Response Modifiers Advisory Committee CBER Center for Biologics Evaluation / office of Biostatistics / NYBC / IMD / National Institute of Health / NMDP / IND MDS / Food and Drug Administration / Cord Blood Allogeneic Cord Blood Each Unit of LifeSouth HPC / FDA / Biostatistics and Epidemiology office of Cellular / Advisory Committee / CIBMTR Center for International Blood / Application Type STN CBER Received Date PDUFA Goal Date Division / /

Person

Shiowjen Lee / Ilan Irony / Wilson Bryan / Stan Lin / Cord Blood Allogeneic Cord Blood / Boguang Zhen / Cord Blood / Gene Therapies / Mark Borigini / /

Position

Team Leader / Director / OCTGT Division / Chief / OBE / Major / /

Product

dextrose / dimethyl sulfoxide / /

PublishedMedium

the Clinical Review / /

SportsEvent

NHL / /

Technology

Pharmacokinetics / cell therapy / transplantation / Pharmacodynamics / adverse event Automated cord blood processing technology / stem cells / /

SocialTag