Table of Content
1. REPORT OVERVIEW 12
1.1 Statement of the Report 12
1.2 Executive Summary 14
1.3 INTRODUCTION 15
1.3.1 Cord Blood: An Alternative Source for HPSCs 15
1.3.2 Utilization of Cord Blood Cells in Clinical Trials 15
1.3.3 The Struggle of Cord Blood Banks 16
1.3.4 Emerging Technologies to Influence Financial Sustainability of Banks 16
1.3.4.1 Other Opportunities to Improve Financial Stability 16
1.3.4.2 Scope for Companion Products 17
1.3.5 Changing Landscape of Cord Blood Cell Banking Market 17
1.3.6 Extension of Services by Cord Blood Banks 17
2. CORD BLOOD & CORD BLOOD BANKING: AN OVERVIEW 18
2.1 Cord Blood Banking (Stem Cell Banking) 18
2.1.1 Public Cord Blood Banks 19
2.1.1.1 Economic Model of Public Cord Blood Banks 19
2.1.1.2 Cost Analysis for Public Banks 21
2.1.1.3 Relationship between Costs and Release Rates 22
2.1.2 Private Cord Blood Banks 22
2.1.2.1 Cost Analysis for Private Cord Blood Banks 23
2.1.2.2 Economic Model of Private Banks 23
2.1.3 Hybrid Cord Blood Banks 24
2.2 Globally Known Cord Blood Banks 25
2.2.1 Comparing Cord Blood Banks 26
2.2.2 Cord Blood Banks in the U.S. 27
2.2.3 Proportion of Public, Private and Hybrid Banks 29
2.3 Percent Share of Parents of Newborns Storing Cord Blood by Country/Region 29
2.4 Pricing for Processing and Storage in Commercial Banks 30
2.4.1 Rate per Cord Blood Unit in the U.S. and Europe 31
2.5 Cord Blood Revenues for Major Cord Blood Banks 32
3. CORD BLOOD BANK ACCREDITATIONS 33
3.1 American Association of Blood Banks (AABB) 33
3.2 Foundation for the Accreditation of Cellular Therapy (FACT) 33
3.3 FDA Registration 33
3.4 FDA Biologics License Application (BLA) License 34
3.5 Investigational New Drug (IND) for Cord Blood 34
3.6 Human Tissue Authority (HTA) 34
3.7 Therapeutic Goods Act (TGA) in Australia 34
3.8 International NetCord Foundation 35
3.9 AABB Accredited Cord Blood Facilities 35
3.10 FACT Accreditation for Cord Blood Banks 38
4. APPLICATIONS OF CORD BLOOD CELLS 39
4.1 Hematopoietic Stem Cell Transplantations with Cord Blood Cells 39
4.2 Cord Cells in Regenerative Medicine 41
5. CORD BLOOD PROCESSING TECHNOLOGIES 43
5.1 The Process of Separation 43
5.1.1 PrepaCyte-CB 44
5.1.2 Advantages of PrepaCyte-CB 45
5.1.3 Treatment Outcomes with PrepaCyte-CB 45
5.1.4 Hetastarch (HES) 46
5.1.5 AutoXpress (AXP) 46
5.1.6 SEPAX 47
5.1.7 Plasma Depletion Method (MaxCell Process) 48
5.1.8 Density Gradient Method 48
5.2 Comparative Merits of Different Processing Methods 49
5.2.1 Early Stage HSC Recovery by Technologies 50
5.2.2 Mid Stage HSC (CD34+/CD133+) Recovery from Cord Blood 51
5.2.3 Late Stage Recovery of HSCs from Cord Blood 52
5.3 HSC (CD45+) Recovery 52
5.4 Days to Neutrophil Engraftment by Technology 53
5.5 Anticoagulants used in Cord Blood Processing 54
5.5.1 Type of Anticoagulant and Cell Recovery Volume 55
5.5.2 Percent Cell Recovery by Sample Size 56
5.5.3 TNC Viability by Time Taken for Transport and Type of Anticoagulant 57
5.6 Cryopreservation of Cord Blood Cells 58
5.7 Bioprocessing of Umbilical Cord Tissue (UCT) 60
5.8 A Proposal to Improve the Utilization Rate of Banked Cord Blood 61
6. CORD BLOOD CLINICAL TRIALS, SCIENTIFIC PUBLICATIONS & NIH FUNDING 64
6.1 Cord Blood Cells for Research 64
6.2 Cord Blood Cells for Clinical Trials 65
6.2.1 Number of Clinical Trials involving Cord Blood Cells 66
6.2.2 Number of Clinical Trials using Cord Blood Cells by Geography 67
6.2.3 Number of Clinical Trials by Study Type 68
6.2.4 Number of Clinical Trials by Study Phase 69
6.2.5 Number of Clinical Trials by Funder Type 70
6.2.6 Clinical Trials Addressing Indications in Children 71
6.2.7 Select Three Clinical Trials Involving Children 72
6.2.7.1 Sensorineural Hearing Loss (NCT02038972) 73
6.2.7.2 Autism Spectrum (NCT02847182) 73
6.2.7.3 Cerebral Palsy (NCT01147653) 73
6.2.8 Clinical Trials for Neurological Diseases using Cord Blood and Cord Tissue 74
6.2.9 UCB for Diabetes 75
6.2.10 UCB in Cardiovascular Clinical Trials 76
6.2.11 Cord Blood Cells for Auto-Immune Diseases in Clinical Trials 76
6.2.12 Cord Tissue Cells for Orthopedic Disorders in Clinical Trials 77
6.2.13 Cord Blood Cells for Other Indications in Clinical Trials 78
6.3 Major Diseases Addressed by Cord Blood Cells in Clinical Trials 79
6.4 Clinical Trials using Cord Tissue-Derived MSCs 79
6.5 Ongoing Clinical Trials using Cord Tissue 81
6.5.1 Cord Tissue-Based Clinical Trials by Geography 81
6.5.2 Cord Tissue-Based Clinical Trials by Phase 82
6.5.3 Cord Tissue-Based Clinical Trials by Sponsor Types 83
6.5.4 Companies S-ponsoring in Trials using Cord Tissue-Derived MSCs 84
6.6 Wharton’s Jelly-Derived MSCs in Clinical Trials 85
6.6.1 Wharton’s Jelly-Based Clinical Trials by Phase 85
6.6.2 Companies Sponsoring Wharton’s Jelly-Based Clinical Trials 86
6.7 Clinical Trials Involving Cord Blood Expansion Studies 87
6.7.1 Safe and Feasible Expansion Protocols 87
6.7.2 List of Clinical Trials involved in the Expansion of Cord Blood HSCs 88
6.7.3 Expansion Technologies 93
6.8 Scientific Publications on Cord Blood 95
6.9 Scientific Publications on Cord Tissue 96
6.10 Scientific Publications on Wharton’s Jelly-Derived MSCs 97
6.11 Published Scientific Papers on Cord Blood Cell Expansion 98
6.12 NIH Funding for Cord Blood Research 99
7. PARENT’S AWARENESS AND ATTITUDE TOWARDS CORD BLOOD BANKING 100
7.1 Undecided Expectant Parents 100
7.2 The Familiar Cord Blood Banks Known by the Expectant Parents 101
7.3 Factors Influencing the Choice of a Cord Blood Bank 102
8. CORD BLOOD: AS A TRANSPLANTATION MEDICINE 103
8.1 Comparisons of Cord Blood to other Allograft Sources 104
8.1.1 Major Indications for HCTs in the U.S. 105
8.1.2 Trend in Allogeneic HCT in the U.S. by Recipient Age 106
8.1.3 Trends in Autologous HCT in the U.S. by Recipient Age 107
8.2 HCTs by Cell Source in Adult Patients 108
8.2.1 Transplants by Cell Source in Pediatric Patients 109
8.3 Allogeneic HCTs by Cell Source 110
8.3.1 Unrelated Donor Allogeneic HCTs in Patients <18 Years 111
8.4 Likelihood of Finding an Unrelated Cord Blood Unit by Ethnicity 112
8.4.1 Likelihood of Finding an Unrelated Cord Blood Unit for Patients <20 Years 113
8.5 Odds of using a Baby’s Cord Blood 114
8.6 Cord Blood Utilization Trends 115
8.7 Number of Cord Blood Donors Worldwide 116
8.7.1 Number of CBUs Stored Worldwide 117
8.7.2 Cord Blood Donors by Geography 118
8.7.2.1 Cord Blood Units Stored in Different Geographies 119
8.7.2.2 Number of Donors by HLA Typing 120
8.7.3 Searches Made by Transplant Patients for Donors/CBUs 121
8.7.4 Types of CBU Shipments (Single/Double/Multi) 122
8.7.5 TNC Count of CBUs Shipped for Children and Adult Patients 123
8.7.6 Shipment of Multiple CBUs 124
8.7.7 Percent Supply of CBUs for National and International Patients 125
8.7.8 Decreasing Number of CBU Utilization 126
8.8 Top Ten Countries in Cord Blood Donation 127
8.8.1 HLA Typed CBUs by Continent 128
8.8.2 Percentage TNC of Banked CBUs 129
8.8.3 Total Number of CBUs, HLA-Typed Units by Country 130
8.9 Cord Blood Export/Import by E.U. Member States 137
8.9.1 Number of Donors and CBUs in Europe 138
8.9.2 Number of Exports/Imports of CBUs in E.U. 139
8.10 Global Exchange of Cord Blood Units 140
9. CORD BLOOD CELLS AS THERAPEUTIC CELL PRODUCTS IN CELL THERAPY 143
9.1 MSCs from Cord Blood and Cord Tissue 143
9.1.1 Potential Neurological Applications of Cord Blood-Derived Cells 144
9.1.2 Cord Tissue-Derived MSCs for Therapeutic use 146
9.1.2.1 Indications Targeted by UCT-MSCs in Clinical Trials 147
9.2 Current Consumption of Cord Blood Units by Clinical Trials 147
9.3 Select Cord Blood Stem Cell Treatments in Clinical Trials 149
9.3.1 Acquired Hearing Loss (NCT02038972) 149
9.3.2 Autism (NCT02847182) 150
9.3.3 Cerebral Palsy (NCT03087110) 150
9.3.4 Hypoplastic Left Heart Syndrome (NCT01856049) 150
9.3.5 Type 1 Diabetes (NCT00989547) 151
9.3.6 Psoriasis (NCT03765957) 151
9.3.7 Parkinson’s Disease (NCT03550183) 151
9.3.8 Signs of Aging (NCT04174898) 152
9.3.9 Stroke (NCT02433509) 152
9.3.10 Traumatic Brain Injury (NCT01451528) 152
10. MARKET ANALYSIS 153
10.1 Public vs. Private Cord Blood Banking Market 155
10.2 Cord Blood Banking Market by Indication 156
11. PROFILES OF SELECT CORD BLOOD BANKS 158
11.1 AllCells 158
11.1.1 Whole Blood 158
11.1.2 Leukopak 159
11.1.3 Mobilized Leukopak 159
11.1.4 Bone Marrow 159
11.1.5 Cord Blood 160
11.2 AlphaCord LLC 160
11.2.1 NextGen Collection System 160
11.3 Americord Registry, Inc. 161
11.3.1 Cord Blood 2.0 161
11.3.2 Cord Tissue 161
11.3.3 Placental Tissue 2.0 162
11.4 Be The Match 163
11.4.1 Hub of Transplant Network 164
11.4.2 Partners of Be The Match 165
11.4.3 Allogeneic Cell Sources in Be The Match Registry 166
11.4.4 Likelihood of a Matched Donor on Be The Match by Ethnic Background 167
11.5 Biocell Center Corporation 169
11.5.1 Chorionic villi after Delivery 169
11.5.2 Amniotic Fluid and Chorionic Villi during Pregnancy 169
11.6 BioEden Group, Inc. 170
11.6.1 Differences between Tooth Cells and Umbilical Cord Cells 170
11.7 Biovault Family 171
11.7.1 Personalized Cord Blood Processing 171
11.8 Cell Care 172
11.9 Cells4Life Group, LLP 173
11.9.1 Cells4Life’s pricing 173
11.9.2 TotiCyte Technology 174
11.9.3 Cord Blood Releases 174
11.10 Cell-Save 175
11.11 Center for International Blood and Marrow Transplant Research (CIBMTR) 176
11.11.1 Global Collaboration 176
11.11.2 Scientific Working Committees 176
11.11.3 Medicare Clinical Trials and Studies 177
11.11.4 Cellular Therapy 177
11.12 Crio-Cell International, Inc. 181
11.12.1 Advanced Collection Kit 181
11.12.2 Prepacyte-CB 181
11.12.3 Crio-Cell International’s Pricing 182
11.12.4 Revenue for Crio-Cell International 182
11.13 Cord Blood Center Group 184
11.13.1 Cord Blood Units Released 184
11.14 Cordlife Group, Ltd. 187
11.14.1 Cordlife’s Cord Blood Release Track Record 187
11.15 Core23 Biobank 190
11.16 Cord Blood Registry (CBR) 191
11.17 Cordlife Group, Ltd. 193
11.18 CordVida 194
11.19 Crioestaminal 195
11.19.1 Cord Blood Transplantation in Portugal 195
11.20 Cryo-Cell International, Inc. 196
11.20.1 Processing Method 196
11.20.2 Financial Results of the Company 196
11.21 CryoHoldco 197
11.22 Cryoviva Biotech Pvt. Ltd 197
11.23 European Society for Blood and Bone Marrow Transplantation (EBMT) 198
11.23.1 EBMT Transplant Activity 198
11.24 FamiCord Group 200
11.25 GeneCell International 200
11.26 Global Cord Blood Corporation 201
11.26.1 The Company’s Business 201
11.27 HealthBaby Hong Kong 202
11.27.1 BioArchive System Service Plan 203
11.27.2 MVE Liquid Nitrogen System 203
11.28 HEMAFUND 203
11.29 Insception Lifebank 204
11.30 LifebankUSA 205
11.30.1 Placental Banking 205
11.31 LifeCell International Pvt. Ltd. 206
11.32 MiracleCord, Inc. 207
11.33 Maze Cord Blood Laboratories 208
11.34 New England Cord Blood Bank, Inc. 209
11.35 New York Cord Blood Center (NYBC) 210
11.35.1 Products 210
11.35.2 Laboratory Services 210
11.36 PacifiCord 212
11.36.1 FDA-Approved Sterile Collection Bags 212
11.36.2 AXP Processing System 212
11.36.3 BioArchive System 212
11.37 ReeLabs Pvt. Ltd. 213
11.38 Smart Cells International, Ltd. 214
11.39 Stem Cell Cryobank 215
11.40 StemCyte, Inc. 216
11.40.1 StemCyte Sponsored Clinical Trials 216
11.40.1.1 Spinal Cord Injury Phase II 216
11.40.1.2 Other Trials 216
11.41 Transcell Biolife 217
11.41.1 ScellCare 217
11.41.2 ToothScell 217
11.42 ViaCord 218
11.43 Vita 34 AG 219
11.44 World Marrow Donor Association (WMDA) 220
11.44.1 Search & Match Service 220
11.45 Worldwide Network for Blood & Marrow Transplantation (WBMT) 221
INDEX OF FIGURES
FIGURE 2.1: Profit Margins of Select Private Cord Blood Banks, 2016-2019 25
FIGURE 2.2: Cord Blood Banks by Size of Inventory 28
FIGURE 2.3: Proportion of Public, Private and Hybrid Banks 30
FIGURE 2.4: Percent Share of Parents of Newborns Storing Cord Blood by Country/Region 31
FIGURE 2.5: Cord Blood Revenues for Companies, 2016-2019 33
FIGURE 3.1: Percent Share of AABB Accredited Cord Blood Facilities by Country 38
FIGURE 5.1: Separation of Buffy Layer 44
FIGURE 5.2: PrepaCyte-CB 45
FIGURE 5.3: Hetastarch (HES) 47
FIGURE 5.4: AutoXpress II 48
FIGURE 5.5: SEPAX 2 48
FIGURE 5.6: Plasma Depletion (PD) Method (MaxCell Process) 49
FIGURE 5.7: Density Gradient Separation of Cord Blood 50
FIGURE 5.8: Early Stage HSC Recovery from Cord Blood by Technologies 51
FIGURE 5.9: Mid Stage HSC (CD34+/CD133+) Recovery from Cord Blood by Technologies 52
FIGURE 5.10: Late Stage HSC Recovery from Cord Blood by Technologies 53
FIGURE 5.11: HSC (CD45+) Recovery Post Process from Whole Blood by Technologies 54
FIGURE 5.12: Days to Neutrophil Engraftment by Technology 55
FIGURE 5.13: Difference in TNC Recovery among Anticoagulants 56
FIGURE 5.14: Type of Anticoagulant and Cell Recovery Volume 57
FIGURE 5.15: Percent Cell Recovery by Sample Size 58
FIGURE 5.16: TNC Viability by Time Taken for Transport 59
FIGURE 5.17: Difference in Recovery of Viable TNC after Thawing 60
FIGURE 5.18: CD34+ Cell Count, CFU and Cell Apoptosis by Cryoprotectants 61
FIGURE 5.19: The Number of Stored and Transplanted CB Units in Korea-CORD by TNC 62
FIGURE 5.20: Number of Stored and Shipped CB Units and Utilization Rate by TNC Count 63
FIGURE 6.1: Number of Clinical Trials as Reported in PubMed.gov from 2000 to 2019 68
FIGURE 6.2: Number of Cord Blood Clinical Trials by Geography as of June 2020 69
FIGURE 6.3: Number of Cord Blood Clinical Trials by Study Type as of June 2020 70
FIGURE 6.4: Number of Cord Blood Clinical Trials by Study Phase as of June 2020 71
FIGURE 6.5: Number of Cord Blood Clinical Trials by Funder Type as of June 2020 72
FIGURE 6.6: Percent Share of Indications in Children tested in Clinical Trials 73
FIGURE 6.7: Percent Share of Diseases in Ongoing Clinical Trials using Cord Blood Cells 80
FIGURE 6.8: Percent Share of Diseases in Clinical Trials using MSCs from Cord Tissue 81
FIGURE 6.9: Number of Cord Tissue-Based Clinical Trials by Geography as of June 2020 83
FIGURE 6.10: Cord Tissue-Based Clinical Trials by Study Phase as of June 2020 84
FIGURE 6.11: Cord Tissue-Based Clinical Trials by Funder Type as of June 2020 85
FIGURE 6.12: Wharton’s Jelly-Based Clinical Trials by Study Phase as of June 2020 87
FIGURE 6.13: Number of Published Scientific Papers on UCB, 2000-June 2020 96
FIGURE 6.14: Number of Published Scientific Papers on Cord Tissue, 2000-June 2020 97
FIGURE 6.15: Number of Published Scientific Papers on Wharton’s Jelly, 2000-June 2020 98
FIGURE 6.16: Number of Published Scientific Papers on Cord Blood Expansion 99
FIGURE 7.1: Percent Expectant Parents who have heard about Cord Blood Banking 101
FIGURE 7.2: Undecided Expectant Parents about Cord Blood Banking 102
FIGURE 7.3: The Familiar Cord Blood Banks Known by the Expectant Parents 102
FIGURE7.4: Factors Influencing the Choice of a Cord Blood Bank 103
FIGURE 8.1: Distribution of Cell Sources in HCTs as Reported in Be The Match, 2019 104
FIGURE 8.2: Comparisons of Cord Blood to other Allograft Sources 105
FIGURE 8.3: Major Indications for HTC in the U.S., 2019 107
FIGURE 8.4: Trend in Allogeneic HCT in the U.S. by Recipient Age, 2000-2018 108
FIGURE 8.5: Trends in Autologous HCT in the U.S. by Recipient Age, 2000-2018 109
FIGURE 8.6: Transplants by Cell Source in Adult Patients, 2010-2019 110
FIGURE 8.7: Transplants by Cell Source in Pediatric Patients <18 Years 111
FIGURE 8.8: Allogeneic HCTs by Cell Source Facilitated by NMDP/Be The Match 112
FIGURE 8.9: Unrelated Donor Allogeneic HCTs in Patients <18 Years/NMDP/Be The Match 113
FIGURE 8.10: Likelihood of Finding an Unrelated Cord Blood Unit by Ethnicity 114
FIGURE 8.11: Likelihood of Finding an Unrelated Cord Blood Unit for Patients <20 Years 115
FIGURE 8.12: Cumulative Probability of having a Stem Cell Transplant by Age 116
FIGURE 8.13: Cord Blood Utilization Trends 117
FIGURE 8.14: Number of UCB Donors Worldwide as Reported by WMDA 118
FIGURE 8.15: Number of CBUs Worldwide as Reported by WMDA 119
FIGURE 8.16: Number of Umbilical Cord Blood Donors by Geography 120
FIGURE 8.17: Number of Cord Blood Units Stored by Geography 121
FIGURE 8.18: Percent Shares of all Registered Donors by HLA Typing Level 122
FIGURE 8.19: Number of Searches Initiated by National Patients for Donors/CBU/Both 123
FIGURE 8.20: Types of CBU Shipments 124
FIGURE 8.21: TNC Count of CBUs Provided for Children and Adult Patients - Single 125
FIGURE 8.22: TNC Count of CBUs Provided for Children and Adult Patients - Multi 126
FIGURE 8.23: Percentage of HPC Products Provided for National and International Patients 127
FIGURE 8.25: Top Ten Countries with Number of Donors Listed per 10,000 Inhabitants 129
FIGURE 8.26: Percentage of HLA Typed CBUs Banked per Continent 130
FIGURE 8.27: Percentage TNC of Banked CBUs 131
FIGURE 8.28: Number of Donors per 10,000 Inhabitants by Select E.U. Countries 139
FIGURE 8.29: Global CBU Shipments by Geography in 2018 142
FIGURE 8.30: Global Shipments of CBUs by Geography in 2012 143
FIGURE 9.1: Percent Shares of Indications Targeted by UCB-MSCs in Clinical Trials 146
FIGURE 9.2: Percent Share of Clinical Indications using UCT-MSCs 148
FIGURE 9.3: Number of UCB Units Released by Cord Blood Registry by Application 150
FIGURE 10.1: Global Cord Blood Banking Market Revenue by Geography 155
FIGURE 10.2: Percent Share of Global Cord Blood Banking Market Revenue by Geography 156
FIGURE 10.3: Percent Share of Global Cord Blood Banking Market, Public vs. Private 157
FIGURE 10.4: Percent Share of Cord Blood Banking Market by Indication 158
FIGURE 11.1: Growth of CBUs on the Be The Match Registry 164
FIGURE 11.2: Growth of CBUs on the Be The Match Registry 165
FIGURE 11.3: Number of Unrelated Donor Transplants Facilitated by NMDP/Be The Match 166
FIGURE 11.4: Diversity of CBUs in Be The Match Registry 167
FIGURE 11.5: Cell Sources for Allogeneic HCT Facilitated by Be The Match Registry 168
FIGURE 11.6: Likelihood of a Matched Donor on Be The Match Registry by Ethnicity 169
FIGURE 11.7: Percent Recovery of Viable Cells by TotiCyte Technology 175
FIGURE 11.8: Growth in Number of New Transplant Patients Registered with the CIBMTR 178
FIGURE 11.9: New Patients per Year Registered with CIBMTR 179
FIGURE 11.10: Transplant Patients by Graft Source Registered with CIBMTR 180
FIGURE 11.11: Crio-Cell International’s Revenues, 2016-2019 184
FIGURE 11.12: Number of Cord Blood Units Stored in CBR and its Competitors 193
FIGURE 11.13: Key Figures of Sales Revenues and Gross Profits for Cordlife, 2014-2019 194
FIGURE 11.14: Revenue and Gross Profit for GCBC, 2015-2019 203
FIGURE 11.15: Percent Share of Units Released by Indication 215
FIGURE 11.16: Key Figures of Sales Revenues and Gross Profits for Vita 34, 2014-2019 220
INDEX OF TABLES
TABLE 2.1: An Overview of Public Cord Blood Banks 19
TABLE 2.2: International Prices of Cord Blood Unit 20
TABLE 2.3: Prices of Cord Blood Units in NMDP Banks in the U.S. 21
TABLE 2.4: An Overview of Private Cord Blood Banks 23
TABLE 2.5: Profit Margins of Select Private Cord Blood Banks, 2016-2019 24
TABLE 2.6: An Overview of Hybrid Cord Blood Banks 25
TABLE 2.7: A Partial List of Global Private Cord Blood Banks 26
TABLE 2.8: Comparison of Three Private Banks 27
TABLE 2.9: Partial List of Public, Private and Hybrid Cord Blood Banks in the U.S. 28
TABLE 2.10: Pricing for Storage in Commercial Banks 30
TABLE 2.11: Rate per Cord Blood Unit in the U.S. & Europe 31
TABLE 2.12: Cord Blood Revenues for Major Four Companies, 2016-2019 32
TABLE 3.1: AABB Accredited Cord Blood Facilities 35
TABLE 3.1: (CONTINUED) 36
TABLE 3.1: (CONTINUED) 37
TABLE 3.2: Select FACT Accredited Cord Blood Facilities 38
TABLE 4.1: Indications for the Use of UCB-Derived Stem Cells for Transplantation 39
TABLE 4.1: (CONTINUED) 40
TABLE 4.1: (CONTINUED) 41
TABLE 4.2: Indications for the Use of UCB-Derived Stem Cells for Regenerative Medicine 42
TABLE 5.1: Advantages of PrepaCyte-CB 45
TABLE 5.2: Treatment Outcomes with PrepaCyte-CB 45
TABLE 6.1: U.S. Cord Blood Banks Supplying Cord Blood for Research 65
TABLE 6.2: Number of Cord Blood Clinical Trials by Geography as of June 2020 68
TABLE 6.3: Number of Cord Blood Clinical Trials by Study Type as of June 2020 69
TABLE 6.4: Number of Cord Blood Clinical Trials by Study Phase as of June 2020 70
TABLE 6.5: Number of Cord Blood Clinical Trials by Funder Type as of June 2020 71
TABLE 6.6: Percent Share of Indications in Children tested in Clinical Trials 72
TABLE 6.7: Select Three Clinical Trials involving Children 74
TABLE 6.8: Ongoing Clinical Trials using UCB for Neurological Diseases 75
TABLE 6.9: Ongoing Clinical Trials using UCB for Diabetes 75
TABLE 6.10: Ongoing Clinical Trials using UCB for Cardiovascular Trials 76
TABLE 6.11: Ongoing Clinical Trials using UCB for Auto-Immune Diseases 77
TABLE 6.12: Ongoing Clinical Trials using UCB for Orthopedic Disorders 77
TABLE 6.13: Ongoing Clinical Trials using UCB for Other Indications 78
TABLE 6.14: Select Clinical Trials using MSCs from Cord Tissue 80
TABLE 6.15: Number of Cord Tissue-Based Clinical Trials by Geography as of June 2020 81
TABLE 6.16: Number of Cord Tissue-Based Clinical Trials by Study Phase as of June 2020 82
TABLE 6.17: Number of Cord Tissue-Based Clinical Trials by Funder Type as of June 2020 83
TABLE 6.18: Select Cord Tissue-Based Clinical Trials by Commercial Entities, 2020 84
TABLE 6.19: Wharton’s Jelly-Based Clinical Trials by Phase, 2020 85
TABLE 6.20: Wharton’s Jelly-Based Clinical Trials by Commercial Entities, June 2020 86
TABLE 6.21: Clinical Trials in Cord Blood-Derived Cell Expansion by Country, 2020 87
TABLE 6.22: Clinical Trials of Cell Expansion Studies by Stages in Development, 2020 88
TABLE 6.23: List of Clinical Trials involved in the Expansion of Cord Blood HSCs 88
TABLE 6.23: (CONTINUED) 89
TABLE 6.23: (CONTINUED) 90
TABLE 6.23: (CONTINUED) 91
TABLE 6.23: (CONTINUED) 93
TABLE 6.24: Cord Blood Expansion Approaches 94
TABLE 6.25: Select NIH Funding for Umbilical Cord Blood Research, 2019-2020 99
TABLE 8.1: Comparisons of Cord Blood to other Allograft Sources in Transplantation 104
TABLE 8.2: Number of HCTs Performed in the U.S. as reported to CIBMTR by Disease 105
TABLE 8.3: Total Number of Cord Blood Donors and Cord Blood Units by Country 131
TABLE 8.3: (CONTINUED) 132
TABLE 8.3: (CONTINUED) 135
TABLE 8.3: (CONTINUED) 136
TABLE 8.3: (CONTINUED) 137
TABLE 8.4: Number of Donors and CBUs by E.U. Country as of December 31, 2018 139
TABLE 8.5: Number of Exports/Imports of CBUs in E.U. in 2018 140
TABLE 9.1: Select 15 Clinical Trials Using Cord Blood-Derived MSCs as Interventions 144
TABLE 9.2: Select Clinical Trials using UCT-MSCs as Interventions 146
TABLE 10.1: Global Cord Blood Banking Market Revenue by Geography 154
TABLE 11.1: AlphaCord’s pricing 160
TABLE 11.2: Cell Care’s pricing for Processing and Storage 172
TABLE 11.3: Cells4Life’s pricing for Cord Blood, Cord Tissue, Amnion and Placental Cells 173
TABLE 11.4: Cord Blood and Cord Tissue Products Released from Cells4Life 175
TABLE 11.5: Distribution of Transplant Patients by Graft Source Registered with CIBMTR 179
TABLE 11.6: Distribution of Transplant Patients by Indication Registered with CIBMTR 180
TABLE 11.7: Crio-Cell International’s pricing for Processing and Storage 182
TABLE 11.8: Crio-Cell International’s Revenues, 2016-2019 182
TABLE 11.9: Cord Blood Units Released from Cord Blood Center Group 184
TABLE 11.9: (CONTINUED) 185
TABLE 11.9: (CONTINUED) 186
TABLE 11.10: Cordlife’s Cord Blood Release Track Record 187
TABLE 11.10: (CONTINUED) 188
TABLE 11.10: (CONTINUED) 189
TABLE 11.11: Core23 Biobank’s Processing and Storage Fees 190
TABLE 11.12: Allogeneic and Autologous Transplantations by Indication Reported in EBMT 199
TABLE 11.13: GeneCell Internationals Prepaid Storage Plans 200
TABLE 11.14: Selected Financial Data for GCBC, 2015-2019 201
TABLE 11.15: Insception Lifebank’s Pricing 204
TABLE 11.16: LifeCell International’s pricing 206
TABLE 11.17: MiracleCord’s Cost Comparison with Competitors 207
TABLE 11.18: Maze Cord Blood Laboratory’s Payment Plans 208
TABLE 11.19: Comparison of Pricing of NECBB with others 209
TABLE 11.20 Stem Cell Cryobank’s pricing for Processing and Storage 215