A Resource for Translational Research

The Translational Therapy Shared Resource provides translational research support services to cancer center members interested in pre-clinical and clinical research involving the development of therapies using biologic products including the large-scale production of human cells. In addition, it offers investigators a wide array of immune monitoring assays to assess the in vivo effects of novel experimental therapies in patients.

Goals of the Translational Therapy shared resource

  • Develop and perform state-of-the-art immune monitoring assays for clinical trials
  • Collaborate with investigators to develop GMP cell processing protocols for clinical trials
  • Provide large-scale blood, marrow and cord blood cell separation, manipulation and culture facilities for basic research

Facilities

Facilities

The large general processing area contains a clinical scale magnetic cell separation device for cell selection and depletion, a controlled rate freezer, a liquid nitrogen storage tank, a floor model centrifuge, a cell counter, a refrigerator, freezers and a fume hood.

In addition, there are three smaller, self-contained processing areas to prevent cross-contamination while working with several products and samples. Each area is equipped with biological safety cabinets, incubators, microscopes and a refrigerator. Incubators, refrigerators and freezers are connected to a remote central alarm system. The gas supply manifold can deliver two gases (CO2 and N2) and is located outside of the laboratory to minimize traffic.

Shared equipment available and/or maintained by the Translational Therapy Shared Resource includes a gamma counter, a beta plate reader, an elispot plate reader and flow cytometers.

These resources enable us to prepare cellular products for use by investigators in their experiments. Specifically, the Translational Therapy Shared Resource will procure, select and manipulate any blood or marrow product including stem cells and lymphocytes for Cancer Center investigators. In addition to processing resting cell populations we may expand into alternative cell sources (e.g. umbilical cord blood and tumor cell lines).

The laboratory information management system (MSC-LIMS) tracks all immune monitoring samples providing real-time results and customized reports. Four workstations are linked via the Masonic Cancer Center server which hosts the database and software for the system.

Services

Services

The Translational Therapy Shared Resource is a fee-for-service resource that provides immune monitoring assays and assistance with the scale-up and transfer of cell processing methods from the basic research laboratory to the clinical cell therapy laboratory.

  • Immunophenotyping
  • Cytotoxicity assays
  • ELISpot to detect antigen recognition
  • Intracellular cytokine staining to detect antigen recognition
  • Tetramer staining to detect antigen specific cytotoxic T-cells

CD34 selected human peripheral blood stem cells are available to investigators. Peripheral blood stem cell collections are performed in University of Minnesota Medical Center, Fairview Apheresis Blood Donor Center on G-CSF stimulated normal donors.  The products are enriched for CD34+ stem cells using the Miltenyi Clinimacs Cell Separation System. Fresh cells are available on the day of selection. Cells are also frozen in vials containing 10-, 20-, or 50-million cells. Other sizes are available on request.

In addition, the Translational Therapy Facility can perform large scale positive or negative cell selection and isolation of other cell populations.

Upon written request, we can provide:

  • Lymphocytes (T-cells, NK, B-cells)
  • Monocytes
  • Dendritic cells
  • Granulocytes
  • Platelets

Meeting investigators' needs

Clinical Trials Research Samples

Research sample processing and specialized testing services are available. We can also process, freeze and ship frozen samples to central repositories. We work closely with the principal investigator and study nurse coordinator to prepare sample collection schedules, orders and request slips. The MSC-LIMS database allows us to track all immunotherapy patient samples and cellular therapy products from clinical research trials. Assay results are entered immediately to provide real-time data to the investigator. Investigators may request individual Sample Summary Reports (email or fax) or aggregate data exported to an excel file or database.

Clinical Trials Product Development

The Translational Therapy Shared Resource serves a crucial role in the development of large-scale therapies for implementation into clinical trials. Special expertise and training regarding current hematopoietic cell therapy guidelines, standard operating procedures, rapidly changing FDA regulations and requirements for IND submission of experimental protocols will be provided by Translational Therapy personnel.

Procedures and Practices

We work closely with the investigator and the Minnesota Molecular and Cellular Therapeutics Facility (MMCT), a GMP clinical production facility, to facilitate the IND process and to develop standard operating procedures that meet current good manufacturing practices.

Equipment

Scale-up and transfer of procedures from the basic laboratory to the clinical laboratory are facilitated by specialized equipment such as the cell separation device and controlled rate freezer. They are designed to process cell suspensions and reagents in sterile, closed systems using bags, tubing and sterile connections allowing the sterile transfer of large numbers of cells and reagent volumes.

Based on the investigator's description of the processes used in their research laboratory we will aid in the development of large-scale methods and processes to meet final product specifications.

Quality

The Translational Therapy Shared Resource operates as a good laboratory practice (GLP) facility. Well-trained personnel perform assays using standardized, validated protocols. We continually develop new methodologies to assess the in vivo immune effects and responses of novel clinical therapies as they are implemented and tested in patients.

Future Directions

The Translational Therapy Shared Resource is working closely with other Cancer Center Shared Resources (Informatics, Clinical Trials Office, Biostatistics) and the University of Minnesota Clinical and Translational Science Award (CTSA) group to develop a database application that will integrate clinical lab data, research lab data and clinical outcomes data to produce datasets for statistical analysis of translational research trials.

To Use Our Services

To provide immune monitoring services, we require a copy of an IRB and CPRC approved clinical protocol (including a schedule of blood draws and assays to be performed) and a CUFS number for billing. We encourage you to contact us during the protocol design for assistance in determining the optimal sample collection time and laboratory assays to answer your research questions. We can provide scientific expertise and procedural support to assist you with the institutional review process and the logistics of collecting research samples as part of a clinical trial.

The Translational Therapy Shared Resource has Institutional Review Board (IRB) approval to procure normal donor cells without any identifiable information to individual donors. However, it is every investigator's responsibility to ensure that IRB approval has been obtained for the collection, testing and storage of human tissue for their research.

Cells purchased from the laboratory, which do not have identifiable information, are to be used only for in vitro research. To use these cells you are only required to fill out a simple application entitled "Request for Exemption from Committee Review of Research Involving Human Subjects."

We require a copy of your IRB approval letter on file and payment method (CUFS number or purchase order) before we can release cells.

Contact

Questions about assay prices, cost estimates for specialized products and services, and requests for any other information may be directed to:

Julie Curtsinger, Ph.D., coordinator, at 612-625-6955 or by email at curts001@umn.edu

Michael Verneris, M.D., Medical Director, at 612-626-2961 or by e-mail at verneris@umn.edu

Rates

Rates

Services and rates for fiscal year 2018 rates

Masonic Cancer Center members receive discounted rates.
Please contact the TTL for additional information.

Category

Test

Description

Rate

  Lab hourly Non-standard assays; rate includes $28 of supplies and reagents per hour billed; customer will be billed separately if supply costs exceed this allowance $155.33
Cell Process Cell Process 1 (no storage) No ficoll, freeze MNC OR DNA only, up to 20 tubes; customer picks up cryovials within 1 week $70.41
Cell Process 1 No ficoll, freeze MNC OR DNA only, up to 20 tubes; customer picks up cryovials within 1 week $63.55
Cell Process 2 (no storage) Ficoll, cell counts, freeze MNC up to 20 tubes; customer picks up cryovials within 1 week $114.14
Cell Process 2 Ficoll, cell counts, freeze MNC up to 20 tubes $125.75
Cell Process 3 Freeze lysed post-ficoll pellet for DNA, 4 tubes
$157.73
Cell Process - Cytoreduction Ficoll, count, freeze up to 300 vials $588.50
Freezer storage, 20 increments > 20 If > 20 tubes frozen, additional charge per 20 tubes $32.62
Other Sample Process Whole blood, aliquot and freeze Prepare up to 4 aliquots of whole blood, store at -80C $13.03
Serum, Plasma, or Urine, simple, no storage Blood or Urine: standard spin and aliquot, no long term storage $18.98
Serum, Plasma, or Urine, simple Blood or Urine: standard spin, aliquot and store $29.42
Serum, Plasma, or Urine, complex, no storage Customer picks up cryovials within 1 week $46.83
Serum, Plasma, or Urine, complex Blood or Urine: non-standard or multiple spins, with aliquot and store $58.43
Sample - no process Blood or other: pick up frozen specimens from other processing lab, store $34.81
Shipping - labor only Cost per box; customer provides shipping supplies $69.62
Shipping - labor, box, dry ice (domestic) Cost per box; TTL provides shipping supplies $98.13
Shipping - labor only (international) Cost per box; customer provides shipping supplies $104.43
Shipping - labor, box, dry ice (international) Cost per box; labor, box, dry ice  $132.94
Cytoxicity Cytotoxicity - 1 target MNC: measure killing of one cell type (target) by Cr51 release $212.64
Cytotoxicity - 2 targets MNC: measure killing of two cell types (targets) by Cr51 release $293.08
Phenotype FACS, 10 color surface, 5-6 tubes Cells: stain up to 10 surface markers  in 5-6 tubes; acquire; analyze; report $250.74
FACS, 10 color surface, 3-4 tubes Cells: stain up to 10 surface markers in 3-4 tubes; acquire; analyze; report $208.37
FACS, 10 color surface, 1-2 tubes Cells: stain up to 10 surface markers in 1-2 tubes; acquire; analyze; report $176.11
FACS, 10 color intracellular, 1-2 tubes Cells: stain up to 10 surface and intracellular markers in 1-2 tubes; acquire; analyze; report $193.01
FACS, 10 color intracellular, 3-4 tubes Cells: stain up to 10 surface and intracellular markers in 3-4 tubes; acquire; analyze; report $219.47
FACS, 10 color whole blood, 1-2 tubes Blood: stain up to 10 surface markers in whole blood in 1-2 tubes; lyse RBCs; acquire; analyze; report $200.87
Functional tests CD107a/ Intracellular cytokine KIR $339.43
Column enrichment, NK cells or CD4 cells Previous name: CD4 enrichment (MS column); now includes column enrichment, NK cells $266.17
Neutralization Assay New for FY18; this test was developed for HM2014-26 $216.19
CFSE Suppression Assay Previous name: CFSE (does not include MS column) $322.20
ELISpot, per sample Previous name: ELISpot; study specific antigens or other reagents will be billed directly to study $359.83
Pentamer- 6 stains Per sample, up to 6 stains; pentamers will be billed directly to study $212.08

 

 

 

Heme Malignancy Tissue Bank

Heme Malignancy Tissue Bank

Heme Malignancy Tissue Bank

Specimen Procurement - for clinical staff collecting blood and bone marrow samples from patients

Request for Samples – for researchers requesting samples from the tissue bank

Heme Malignancy Tissue Bank samples are available to any member of the UMN research community.  Preference is given to Masonic Cancer Center members.  Release of samples will be approved after a peer-review process.  Prior to request investigators should demonstrate that methods and approaches are established in their laboratory or that such studies cannot be performed with cell lines.  Typically small numbers of samples will be initially released so that investigators can demonstrate that the samples are useful to their research.  
 
Two steps must be completed before sample release:
  1. Request for Samples Form
  2. IRB Approval

At the time of a suspected eligible diagnosis or suspected relapse, patients are asked to allow the collection of extra blood, bone marrow, and/or apheresis specimens. If consent is obtained, the specimens are collected at the same time as routine diagnostic procedures needed for diagnosis or treatment.

At the time of consent, each patient is assigned a unique study identifier by the Pediatric Leukemia Coordinator. Collected specimens are processed, frozen and stored at the Masonic Cancer Center’s Translational Therapy Laboratory. Any patient identifiers are removed, and samples are stored with only the unique study identifier. The link between study identifier and clinical information is maintained by the Pediatric Leukemia Coordinator.  The records are stored on a password-protected University of Minnesota server. Access to the electronic files is limited to the Heme Malignancy Tissue Bank staff.

Each researcher must obtain IRB approval (IRB Category 4: Exempt from Committee Review) for the use of specimens in their specific research projects. Samples released to researchers will be labeled only with the unique patient identifier; there will be no link to personal identifiers. De-identified clinical information (such as diagnosis, cytogenetics or translocation, percentage blasts, age, sex, etc.) may be provided by the Pediatric Leukemia Coordinator or approved clinical research staff.

Grant & Publication Information

  • Grant Submission Information:
    PI: Veronika Bachanova, MD, PhD
    IRB #: 0611M96846
  • Publication Acknowledgement:
    The Heme Malignancy Tissue Bank (HMTB) receives support from the National Cancer Institute, Minnesota Masonic Charities and the Killebrew-Thompson Memorial fund through the Cancer Experimental Therapeutics Initiative (CETI). PIs using samples from the HMTB should acknowledge this support in any publications and presentations: “This work was supported in part by NCI 5P30CA077598-18, Minnesota Masonic Charities and the Killebrew-Thompson Memorial Fund.”

Contact Information

  • Sample Collection and Consent:
    Barb Trotz
    Phone: 612-624-2437
    Pager: 612-899-8209
    trotz002@umn.edu
  • Research Coordinator
    Jamie Walski
    Phone: 612-625-7908
    Pager: 612-899-2551
    wals0183@umn.edu
  • Adult Patients:
    Veronika Bachanova
    Phone: 612-625-5469
    Pager: 612-899-1200
    bach0173@umn.edu

 

Staff

Co-directors
John Wagner, M.D.

Office: 660D Masonic Cancer Center Research Building
612-626-0474
wagne002@umn.edu

Martin Felices, Ph.D.
Office: 660A CCRB
612-625-8942
mfelices@umn.edu

Coordinator
Julie Curtsinger, Ph.D. 

612-625-6955

curts001@umn.edu

Video on services provided