Cord Blood Bankers are Angie Yost, MT(ASCP) CM 2016 ASCLS-MO CLMA Spring Meeting
Objectives Cord blood 101 Manufacturing and cryopreservation Characterization testing
Why Do We Need Cord Blood? Each year, thousands of people are diagnosed with leukemia, lymphoma, or immune system or genetic (inherited) disorders. People with these diseases have abnormal or non-functional blood-forming cells. A stem cell transplant replaces a patient s diseased bloodforming cells with healthy cells. Healthy cells from another individual must be matched.
Stem Cell Sources There are 3 primary sources of adult stem cells for patients needing transplant. Bone Marrow Peripheral Blood Cord Blood
What is Cord Blood? Blood that remains in the umbilical cord and placenta after a child is born Rich source of adult stem cells Similar to those found in bone marrow Obtained from a developed person Self-renewing source of life-long production of red blood cells, platelets, and white blood cells Non-controversial Collected after baby is born No harm to mother or baby
What is Cord Blood?
What Are The Benefits of Cord Blood? Abundant resource: 4 million births/year in the U.S. Placental barrier reduces environmental exposure & contamination from viruses Easier access when needed-prompt access-low attrition Lower rate of rejection More flexible matches
What Diseases Can Be Treated With Cord Blood? Acute and Chronic Leukemias Congenital Immune System Disorders Histiocytic Disorders Inherited Erythrocyte Abnormalities Liposomal Storage Diseases Lymphoproliferative Disorders Myelodysplastic Syndromes Myeloproliferative Disorders Other Inherited Disorders Plasma Cell Disorders Phagocyte Disorders Solid Tumors/Other Malignancies Stem Cell Disorders
How Are Public And Private Cord Blood Banks Different? Public cord blood bank No cost to donor Units available to unrelated recipients worldwide by HLA match Required testing for infectious diseases Subject to stringent regulations for good manufacturing practices Private cord blood bank Initial collection fee and annual storage fee Units only available to donor and donor s family Infectious disease testing not required for autologous donation Minimum regulations since future use not based on disease treatment
How is Cord Blood Regulated?
How is Cord Blood Regulated? Due to intended use in allogeneic recipients, cord blood is classified as a biologic drug Regulated under the more stringent current Good Manufacturing Practice (cgmp) rules & biologics standards similar to pharmaceuticals Each cord = unique biological component; cells vs. chemicals Lot sizes = single patient lot vs thousands of tablets Manufacturing process controls = drugs can be terminally sterilized; cord blood manufacturers rely on aseptic processing
How Are Cord Blood Units Selected for Manufacture? Selection Criteria Weight (indicator of volume) Total Nucleated Cell count (TNC) (WBC s + NRBC s) Maternal history questionnaire review Maternal tubes for infectious disease testing
From Cord Blood to HPC, Cord Blood
From Cord Blood to HPC, Cord Blood
How is Cord Blood Cryopreserved? http://cellularemolecolare.listarfish.it/index.php?option=com_content&id=75&task=view DMSO Controlled Rate Freezer Liquid Nitrogen Storage
How is Cord Blood Cryopreserved?
How is Cord Blood Characterized? Run samples on hematology analyzer to evaluate WBC and NRBC counts
How is Cord Blood Characterized? Run samples on flow cytometer to evaluate WBC and HPC count
How is Cord Blood Characterized? Perform trypan blue viability counts
How is Cord Blood Characterized? Plate, incubate, and read CFU assays CFU-E BFU-E CFU-GM CFU-GEMM
How is Cord Blood Characterized? Perform preand postprocessing ABO/Rh typing
How is Cord Blood Characterized? Prepare Whatman filter paper cards for HLA typing
How is Cord Blood Characterized? hemoglobinopathy Prepare samples for hemoglobinopathy testing
How is Cord Blood Characterized? Inoculate, incubate, and evaluate blood bottle cultures (aerobic, anaerobic, and fungal)
How is Cord Blood Characterized? Environmental monitoring of personnel and work spaces
How is Cord Blood Characterized?
How is Cord Blood Characterized?
How is Cord Blood Characterized?
How is Cord Blood Characterized? Prepare maternal samples for infectious disease testing
How is Cord Blood Characterized? Freeze aliquots of pre- and postprocessing, as well as maternal samples
The REAL Heroes
Why We Do What We Do! The chemo I had when I was eight years old killed my cancer, but along with it my bone marrow. I wasn t making anything on my own anymore. A bone marrow transplant could repopulate her blood-forming cells, but her parents and two younger sisters did not match her blood type. Before we could worry, they told us, But we have cord blood.
Why We Do What We Do! Now I want to help other people.
Find Out More www.slcbb.org On Facebook
Thank you!