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1 Upstate Cord Blood Bank

2 Hematopoietic Progenitor Cells Hematopoiesis i starts from self renewing HPC HPC differentiates t to sequentially more mature blood cells HPC circulate in very low numbers in adults (< 0.01%)

3 Collection of Cord Blood Cord Blood Stem Cells Collected from umbilical vein of placenta soon after birth Collect ml total volume 1.25 x 10 6 CD34+ cells Normally disposed of as medical waste cbcollection2.jpg

4 Processing of Cord Cells Cord blood is aseptically yprocessed Stem cells recovered in freezing bag while RBC and plasma separated tdduring automated t processing Cells in RBC bag are retained for DNA isolation and testing for hemoglobinopathies Aliquots of plasma retained per FACT, FDA, and NMDP regulations

5 Processing of Cord Cells Cord blood is aseptically yprocessed Total volume measured Samples removed to measure: Total number of nucleated cells % of nucleated cells CD34+ Bacterial contamination Additional samples stored for future testing

6 Processing of Cord Cells Cord blood must be frozen to prevent apoptosis and senescence of cells Liquid nitrogen Freezing results in ice crystal formation causing cell lysis DMSO is added in sterile conditions to stabilize cells

7 Upstate Cord Blood Bank

8 Upstate Cord Blood Bank Separate manufacturing zones in order to maintain cord blood safety

9 Upstate Cord Blood Bank Opening Summer 2016

10 FDA Regulation of a Cord Blood Bank (Tissue Bank) FDA regulation of a GxP facility (regulated as a drug and as a biologic) FDA regulates hematopoietic stem/progenitor cells for unrelated use g p p g as a DRUG under FD&C Act and as a BIOLOGICAL PRODUCT under the PHS Act.

11 Regulatory Oversight (FDA/FACT/AABB/CLIA/CAP/NYS DOH) Collection Hospitals NMDP UMU CBBs CIBMTR FACT: Foundation for the Accreditation of Cellular Therapy AABB: American Association of Blood Banks CLIA: Clinical Laboratory Improvements Amendments CAP: College of American Pathologists NMDP: National Marrow Donor Program CIBMTR: Center for International Blood Marrow Transplant Research International Transplantation Centers

12 FDA Regulation of a Cord Blood Bank (Tissue Bank) How does a DRUG/BIOLOGIC become Standard of Care?

13 Clinical Trial Pathway y( (Progression from IND to BLA) Basic Discovery Preclinical Preclinical Research Research Research Develop. Early Clinical i l Research Late Clinical i l Research Development Candidate IND Filed BLA Filed

14 Clinical Trial Pathway y( (Progression from IND to BLA) Basic Research Discovery Research Preclinical Research Preclinical Develop. Early Clinical Research Late Clinical Research Development Candidate IND Filed BLA Filed = Potential involvement of cord blood banks

15 Current FDA BLA-Approved Cord Blood Uses and FDA IND-Approved Cord Blood Uses CD34+ Cells Hematologic Malignancies, Anemia, SCA Cord Blood Treatment/Cure

16 Current FDA BLA-Approved Cord Blood Uses and FDA IND-Approved Cord Blood Uses CD34+ Cells Hematologic Malignancies, Anemia, SCA MNC Critical Limb Ischemia, Spinal Cord Injury Cord Blood MSC Diabetes Mellitus, Alzheimer's, Cartilage Injury, GvHD CD4+ CD25+ T reg Diabetes Mellitus ALDH bright Critical Limb Ischemia, Myocardial Ischemia, Stroke Dendritic Cells Vaccine (Ag Viral/Fungal Infections, Anti-Tumor) Treatment/Cure Treatment/Cure? Autism, Osteopetrosis, Hypoplastic Heart, Stroke, Cerebral Palsy, Chronic Traumatic Brain Injury, Transfusion for Preterm Neonates, Neonatal Hypoxic-Ischemic Encephalopathy, Chronic Injured Spinal Cord, Acquired Hearing Loss in Children Serum/Plasma Eye Abrasions

17 Current FDA BLA-Approved Cord Blood Uses and FDA IND-Approved Cord Blood Uses pcbb, allogenic CD34+ Cells Hematologic Malignancies, Anemia, SCA MNC Critical Limb Ischemia, Spinal Cord Injury Cord Blood MSC Diabetes Mellitus, Alzheimer's, Cartilage Injury, GvHD CD4+ CD25+ T reg Diabetes Mellitus ALDH bright Critical Limb Ischemia, Myocardial Ischemia, Stroke fcbb, autogenic Treatment/Cure Treatment/Cure? Dendritic Cells Vaccine (Ag Viral/Fungal Infections, Anti-Tumor) Autism, Osteopetrosis, Hypoplastic Heart, Stroke, Cerebral Palsy, Chronic Traumatic Brain Injury, Transfusion for Preterm Neonates, Neonatal Hypoxic-Ischemic Encephalopathy, Chronic Injured Spinal Cord, Acquired Hearing Loss in Children Serum/Plasma Eye Abrasions

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