Translational Cell Therapy
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.
The goals of the Translational Therapy Shared Resource are to:
- 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
Video on Services Provided by the Translational Therapy Resource
Michael Verneris, M.D.
Office: 654B Masonic Cancer Center Research Building
Julie Curtsinger, Ph.D.
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.
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.
- 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)
- Dendritic cells
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.
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.
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.
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.
Questions about assay prices, cost estimates for specialized products and services, and requests for any other information may be directed to:
|Cell Process 1||$59.52|
|Cell Process 2||$97.27|
|Cell Process 3||$121.98|
|Cell Process - Cytoreduction||$503.70|
|Freezer storage, 25 increments > 25||$25.15|
|Serum, Plasma, or Urine, no storage||$15.13|
|Serum, Plasma, or Urine, simple||$23.47|
|Serum, Plasma, or Urine, complex||$46.65|
|Sample - no process||$27.82|
|Shipping - labor only||$55.64|
|Shipping - labor, box, dry ice||$75.64|
|Cytotoxicity 1 target||$165.03|
|Cytotoxicity 2 targets||$223.71|
|FACS, 10 color surface, 5-6 tubes||$191.75|
|FACS, 10 color surface, 3-4 tubes||$160.89|
|FACS, 10 color surface, 1-2 tubes||$137.13|
|FACS, 10 color intracellular, 1-2 tubes||$151.26|
|FACS, 10 color intracellular, 3-4 tubes||$169.82|
|FACS, T-reg, 2-tube||$143.37|
|FACS, 10 color whole blood, 1-2 tubes||$156.77|
|FACS, whole blood, 1-3 tubes||$141.27|
|Column enrichment, NK cells or CD4 cells||$207.11|
|CFSE Suppression Assay||$248.67|
|ELISpot, per sample||$279.60|
|Pentamer - 6 stains||$162.36|