The Cord Blood Subsection develops resource materials that address a variety of issues related to this cell source.

Learning Tools

Umbilical Cord Blood Collection
Delayed Cord Clamping: A Literature Review (PDF) - 2/29/12
Consumables and Equipment: Electronic Tracking (PDF) - 8/27/13

Presentations

ISBT 128 Labeling of Cord Blood (PDF)
Passive vs Controlled-Rate Freezing Quality of HPC Products (PDF)
Generation of MSCs from UC Tissue Using Enzyme-Free Tissue Homogenization (PDF)
CB Post-Thaw Process and Testing- Challenges and Initiatives (PDF)
Effect of Volume Reduction of CB Units on TX Outcomes - Retrospective Analysis (PDF)
Development and Validation of a Rapid ALDH Bright Cord Blood Assay (PDF)
Microbiology Lab in CBB Facility: Operational Aspects and Merits (PDF)
Expansion of NK Cells from Cryopreserved Cord Blood Cells (PDF)
NMDP Cord Blood Advisory Group Organization and Highlights (PDF)

The APG discusses topics and develops projects relevant to many of the subsection areas with emphasis on cord blood issues and potentially unique regional challenges.

Presentations

Clinical Trials: Moving Cell-Based Therapies to the Clinic (PDF)
ISBT 128: Overview and Implementation for Cellular Therapy (PDF)
How to Set Up a New Stem Cell Processing Laboratory (PDF)
Advances in Gene Therapy and Considerations for Blood Centers (PDF)
Transfusion Associated GvHD (PDF)
Adoptive Immunotherapy (PDF)
Clinical Translational of Vascular Niche for Hematopoietic Stem Cell Expansion and Transplant (PDF)
Establishment of Umbilical Cord Tissue-Derived MSC Bank (PDF)
CAR T Cell Manufacturing Challenges (PDF)
Stem Cells in Cancer Therapy (PDF)
Translating Cell and Gene Therapies From Lab to Clinic (PDF)
The 7th Edition of Standards for Cellular Therapy Services (PDF)
Optimizing HSPC Quantities for Cellular Therapy (PDF)
Ethics of Hybrid Cord Blood Banking (PDF)
Transplant Darwinism: Evolution of HCT (PDF)
Regulatory Convergence for Advanced Therapies - An APEC Initiative (PDF)
HLA Basics and Beyond (PDF)
Improving the Outcome of UCB Transplantation through Ex Vivo Expansion or Graft Manipulation (PDF)
Role of Private Cord Blood Banks (CBB) in Regenerative Medicine (PDF)
Importance of Flow Cytometry - Thawed Cord Blood Products (PDF)
Global Status of ISBT 128 Implementation for Cellular Therapy (PDF)
Novel Strategies of Graft Manipulation for Haploidentical Stem Cell Transplantation (PDF)
Cord Blood Banking Regulation and Operation in Thailand (PDF)
Singapore Cord Blood Bank (PDF)
Activities of Allcord - Public Cord Blood Bank Seoul South Korea (PDF)
Cord Blood Banking in Japan (PDF)
Essential Requirements for Setting Up a Stem Cell Processing Laboratory (PDF)
Cleanroom in the Desert (PDF)
Current Thawing and Infusion Practice of Cryopreserved Cord Blood (PDF)

This subsection addresses topics surrounding the development and processing of cellular therapies including collection of cells from a variety of sources, manufacturing, testing, and strategies used in novel therapies and clinical practices.

Evaluation Tools

The resources listed below are intended as points to consider in evaluation of products and supplies in a systematic manner:
Validation Sample SOP (PDF)

Development - Translation Tools

To assist individuals in practices from bench to bedside:
Checklist - Implementation of Manufacturing and Clinical Trial Logistics (PDF)

Learning Tools

Informational resources:
X-Ray Effects on HSC Products (PDF)

Writing Tools

To assist individuals in writing procedures:
SOP Writing Guide (PDF)
Flowchart Details Template (PDF)

Presentations

Sampling of presentations from invited experts:
Process Development Considerations for Cryopreservation of Cellular Therapies (PDF)
CT Translational Regenerative Rehabilitation Therapies (PDF)
Development - Validation of Rapid ALDH Bright-Based CB Potency Assay (PDF)
MSC Therapies for GvHD in the Clinic - An Update (PDF)
Human Platelet Lysate - Potential Uses (PDF)
How to Prepare for FDA Approval of CAR-T Treatment (PDF)
Choosing and Monitoring the Right Manufacturing Environment for Your Cell Product (PDF)
Preparing to Transition From An Older to Newer LIMS Platform (PDF)
Beyond the ISHAGE - Evolving Guidelines for CD34 Enumeration (PDF)

Publications

Several members have published articles based on CT subsection activities:
Transfusion Practices for Bone Marrow Harvests: A Survey Analysis from the AABB Bone Marrow Quality Improvement Initiative Working Group
Use of Laboratory Tests to Guide Initiation of Autologous Hematopoietic Progenitor Cell Collection by Apheresis: Results from the Multicenter Hematopoietic Progenitor Cell Collection by Apheresis Laboratory Trigger Survey
The Importance of Flow Cytometry in Measuring Viability and How it Affects Thawed Cord Blood Products (PDF)

This subsection addresses regulatory issues, Guidance documents, quality program design, risk management, vendor and supply qualification, facility, environmental operational controls and how good management principles support these activities.

Presentations

Sampling of presentations from invited experts:
Blood Center Considerations for Product Collections, Processing and Distribution (PDF)
ICBS 2018 Review - One Viewpoint (PDF)
Long Term Safety Assessments on Patients Who Receive Genetically Modified Products (PDF)
Benchmarking Cell Therapy Lab Quality (PDF)
Manufacture of Pancreatic Islets to Achieve the BLA: A Multi-Center Approach (PDF)
Implementation of ISBT 128 Product Labeling at NMDP Centers (PDF)
Achieving Quality Through Data Management (PDF)
Improving Quality Through Environmental Assessments (PDF)
Improving Quality through Effective and Timely CAPA (PDF)

Management Tools

Service Level Agreement (PDF)
Examples of Job Descriptions (PDF)
Improving User Engagement in Webinars (PDF)

LEAN

LEAN embodies a way of thinking to maximize value and minimize waste.
LEAN: Glossary of Terms (PDF)
Example of LEAN Approach in the Clinical Laboratory (PDF)
Case Studies - LEAN Workflow and Staffing to Workload in a CT Laboratory (PDF)

Business Planning

The formation of successful businesses often begins with a proposal or business plan. Starting a plan, however, can be daunting. What should be included? What is the vision? What are the economic drivers? To help address some of these questions, templates have been developed to serve as examples. The business plan template includes sample structures, processes and quality components for either internal or external organization audiences. The template for a proposal to modify a current business model for an internal organization audience is also included.

Business Planning Outline (PDF)
Creation of a Program Template (PDF)
Changing a Business Model Template (PDF)

The Spanish Language Subsection develops resource materials in Spanish that address cellular therapy issues.

Presentations

Herramienta de Auditoría ISBT 128 para Terapia Celular (PDF)
cGMP (PDF)
Importancia Clínica de los Anticuerpos HLA en el Transplante de Células Progenitoras Hematopoyéticas (TCPH) con Donantes Parcialmente Incompatibles (PDF)
Virus del Zika: Datos Epidemiológicos Actuales de la CDC (PDF)
Fiebre Amarilla (PDF)
Comparación de Dos Metodologías para el Enriquecimiento de Células Mononucleares de Productos de Sangre De Cordón Descongelado: El Sistema Automatizado de Sepax Versus El Método Manual de Ficoll (PDF)
Biovigilancia y Notifylibrary (PDF)​
Traduciendo Terapias Celulares y Genéticas: del Laboratorio a la Clínica (PDF)
Bancos de Cordón 2.0 (PDF)
Tejido Adiposo - Situación Actual de la Industria y la Ciencia (PDF)
Introducción al Estándar ISBT 128 (PDF)
Procesamiento de Tejido de Cordón (PDF)