Hematopoietic Biorepository and Cellular Therapy

Services

The Hematopoietic Biorepository and Cellular Therapy Shared Resource (SR) serves as a resource for procurement, processing, storage, banking, analysis, and distribution of cells derived from clinical-grade production, human blood, bone marrow, and umbilical cords.

The SR is comprised of two components:

1. A human hematopoietic biorepository and support services to facilitate basic hematopoietic research

2. A clinical Cellular Therapy Lab that manufactures clinical-grade cell products for investigational and standard of care therapies

Facility Objectives

• To procure, de-identify, process and distribute human blood, umbilical cord blood, and bone marrow cells from healthy volunteers and patients to investigators
• To maintain a biorepository of collected samples
• To perform and assist investigators with standard assays to evaluate hematopoiesis and hematopoietic and mesenchymal stem cells
• To support cell therapy-based clinical trials from the proof of concept stage throughout the clinical trial

List of Services

1. Procurement and distribution of human hematopoietic cells:
   • The SR maintains an active IRB protocol to enable the recruitment of donors and procurement and distribution of de-identified blood and bone marrow samples to research investigators. We also maintain a Biorepository to supply investigators with cryopreserved samples. Sample types obtained include:
     • Normal donor blood
     • Normal donor bone marrow aspirate and/or biopsy samples
     • Umbilical cord blood
     • Peripheral mobilized hematopoietic progenitor cells
     • Bone marrow mesenchymal stem cells
     • Blood and/or bone marrow from patients with a wide variety of hematologic diseases including AML, ALL, CML, CLL, multiple myeloma, and anemia
2. Processing and analysis of hematopoietic cells:
   • The SR assists investigators with the processing and analysis of hematopoietic cells using a variety of methodologies. Examples of some of these procedures include:
     • Separation of mononuclear cells by density gradient (Ficoll-Hypaque or Percoll)
     • Cell enrichment using CliniMACS magnetic bead separation (ex. CD34+ cell isolation)
     • Isolation and expansion of mesenchymal stem cells
     • Maintenance of specialized equipment available for research use including a hematology analyzer to perform CBCs
     • Performance of colony forming unit assays (CFU) on blood and bone marrow products
     • Separation of plasma/serum
3. Production of clinical grade cellular therapy products
   • Isolation of specific cell subsets (CD34, CD3, CD14, etc.)
   • Expansion of various cell types upon request
   • Ex-vivo lentiviral gene transfer
4. Support capabilities to transition preclinical studies into clinical trials
   • Assistance in the design and preparation of cells for Good Laboratory Practices (GLP) safety studies
   • Investigational New Drug Application (IND) preparation
   • Sourcing of clinical grade supplies and reagents
   • Scale up from research to clinical operations, including preparation of investigational clinical therapy grade cellular products
   • GMP training to lab investigators

Resources

Hemavet Hematology Analyzer
Guava Cytometer
Biorad QPCR machine
ISO 7 cleanroom suites (6) each with incubators, centrifuge, biosafety cabinet, microscope, refrigerator
GMP-trained lab personnel
COBE closed system cell washer
Rate controlled freezing chamber
Clinical grade Cytokine stocks: Interleukins 3 and 6, stem cell factor and Flt-3 ligand, thrombopoietin
VarioMACS columns/antibody cocktails for routine separation of CD34+ cells and other cell subsets
Shandon Cytospin

Acknowledgment

Remember to acknowledge the valuable services provided by Cancer Center Shared Resources in your research papers and publications: 
"This research was supported by the Hematopoietic Biorepository and Cellular Therapy Shared Resource of the Case Comprehensive Cancer Center (P30CA043703)."

Contact for Information