Developmental Cell Therapy

GENERAL DESCRIPTION

The developmental Cell Therapy Core serves as a resource for all members of the GCRC interested in clinical research involving new cellular and immunotherapies involving large-scale production of biologic products as well as immunological monitoring of patients who receive such therapies. The goals of the Developmental Cell Therapy Core Facility are to:

• aid in the development of large-scale processing and production of cells for clinical trials

• provide immunological testing of patient samples to monitor toxicity and efficacy of cellular and immunotherapies.

CONTACT

Questions and requests for information may be directed to Sue Fautsch, Coordinator, at 612-625-6955 or fauts001@umn.edu or Dr. Jeffrey Miller, Medical Director, at 612-625-7409 or by e-mail at mille011@umn.edu.

SERVICES

Facilities

The large general processing area contains a clinical scale, magnetic cell separation device for positive cell selection and depletion, cell washer, controlled rate freezer, liquid nitrogen storage tank, elutriator, floor model centrifuge, cell counter, ELISA plate reader, refrigerator, freezers, and fume hood. In addition, there are three small self-contained processing areas. Each is equipped with biological safety cabinets, incubators, microscopes, water bath, centrifuge and refrigerator. Incubators, refrigerators, and freezers are connected to a remote alarm system. The gas supply manifold can deliver two gases (CO2 and N2) and is located outside of the laboratory to minimize traffic. Available shared equipment include beta and gamma counters, flow cytometers, irradiator.

Equipment

Scale-up and transfer of procedures from the basic laboratory to the clinical laboratory are facilitated by equipment designed for using bags, tubing and connectors allowing the sterile transfer of cell suspensions and reagents. Equipment such as the cell separation device, cell washer, and controlled rate freezer can handle large volumes of cells and reagents. The investigator describes the current method used in the research laboratory and we develop a large-scale method and process to meet final product specifications.

Clinical Trials Development

The developmental Cell Therapy Core will also serve 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 the Developmental Cell Therapy Core personnel. Products currently in clinical trial include allogeneic natural killer (NK) cells and large multivalent immunogen (LMI) tumor vaccine.

Immune Monitoring

Assays currently offered include:

• Lymphocyte proliferation assays (antigen specific responses to KLH, tetanus toxoid, normal lymphocytes)

• Antigen presenting cell function

• Phenotype

• Cytotoxicity

• Antibody levels (ELISA)

• Elispot

• Intracellular cytokine

• Tetramer

• Freeze and store cells and serum for future studies