The Elmer and Sylvia Sramek Charitable Foundation has awarded over $800,000 to Rush to build and staff the facility where clinical grade human cellular components can be developed to treat patients with certain cancers for Dr. Hans Klingemann, director of the section of Bone Marrow Transplantation and Cell Therapy at Rush.
"This facility will be like a pharmacy, but instead of dispensing drugs it will dispense cells," said Klingemann. "Immunotherapy -- using the patient's own cells to treat cancer -- is increasing and has proven to be very successful." Equally important, the Rush facility will comply with federal Food and Drug Administration's (FDA) new standards for Good Manufacturing Practice (GMP) and Good Tissue Practices (GTP). Referred to as a "clean room" facility, ultra sterile techniques including clean air circulation are required. This facility must have a specially trained staff experienced in clinical grade cell expansion procedures and familiar with meticulous procedure documentation according to GMP and GTP regulations.
"To perform sensitive human cell and tissue work, researchers need a clean room that meets these FDA regulations," said Richard Meagher, Ph.D., director of the Sramek Center. "We will accurately track each step and all actions that occur and will be able to recreate each component's manufacturing history from collection through infusion into the patient." Meagher said this facility would allow the Sramek Center to offer its services to area hospitals and biotechnology firms as an external lab to handle sensitive human tissue and cell research and treatment.
Historically, cancer treatments relied primarily on surgery, radiation and/or chemotherapy. In the last decade, however, scientists have realized that when cancer occurs, it is because the patient's immune system failed to recognize cancer cells as foreign and to attack and eliminate them as it does, for example, with bacteria.
The initial focus of the laboratory will be on the proliferation, or expansion, of certain cellular components, particularly dendritic cells for tumor vaccination, and a natural killer cell line known as NK-92. Dendritic cells are used to fight lymphomas, while NK-92 is used to treat kidney cancers and melanoma of the skin. One of the first cell therapy treatments to be studied will be with NK-92 cells grown in the Sramek Center facility. NK-92 is a unique cell line developed by Klingemann in 1992. Patients with renal cell carcinoma and melanoma will be enrolled in a study using NK-92 cells to determine whether the cells can control the disease. These cells have been shown to be effective in pre-clinical cancer trials with mice. Rush is the only site in the United States where NK-92 cells will be available and used for cancer patients in addition to regular drug treatment.
Another new application will be the use of patient tumor-primed dendritic cells to treat a variety of cancers. In the new laboratory, dendritic cells will be expanded from peripheral blood drawn from a patient or donor. The cells will be separated and then placed in a special container called a bioreactor which contains special nutrients and growth factors (growth promoting proteins) to help the cells proliferate. Tumor cells collected from the patient will be used to teach the dendritic cells to recognize the diseased cell as cancer -- a process that normally takes two to three weeks in the laboratory.
The re-educated cells, with the ability to identify and destroy cancerous cells, are then removed, purified and injected into the patient. Interleukin-2 is a growth factor that stimulates the growth of lymphocytes and killer cells. This growth factor will be given to the patient after the dendritic cells have been injected to promote the proliferation of the newly educated lymphocytes and killer cells.
Many cancers have characteristic molecules or tumor antigens on their surface. T-cells can recognize and bind to these molecules which are called "markers." After manipulation and expansion in the laboratory, T-cells are reintroduced into the patient and redirected toward the cancerous cells in the body using the markers on the surface of the cancerous molecules to guide them to their target.
The circumstances surrounding individuals who undergo an organ transplant illustrate the importance of the immune system in the prevention of cancer. Patients who undergo organ transplantation are required to take immune-suppressant drugs that prevent their bodies from producing antibodies and rejecting the new organ. These drugs work by suppressing T-cells, the cells responsible for attacking infected or cancerous cells and triggering production of antibodies. With no antibodies being produced, viruses like EBV (Epstein-Barr Virus) arise because they are not "checked" by the body's own defense mechanism. EBV and certain other viruses can cause certain types of cancer.
"The only effective treatment for EBV is the infusion of re-educated and stimulated T-cells from the blood of the patient or a tissue-matched sibling," said Klingemann. "Some types of cancers that are virus driven may be responsive to such cellular treatment."
The Elmer and Sylvia Sramek Charitable Foundation was established in 1995 after the death of Elmer Sramek. The Foundation, named for Mr. Sramek and his sister, Sylvia, was established to provide grants for a broad range of charitable purposes. The Foundation seeks to fund specific projects associated with developing treatments and a cure for cancer, as well as the prevention and cure of visual impairments in the elderly.
Rush-Presbyterian-St. Luke's Medical Center includes the 809-bed Presbyterian-St. Luke's Hospital; 154-bed Johnston R. Bowman Health Center for the Elderly; Rush University (Rush Medical College, College of Nursing, College of Health Sciences and Graduate College); and seven Rush Institutes providing diagnosis, treatment and research into leading health problems. The medical center is the tertiary hub of the Rush System for Health, a comprehensive healthcare system capable of serving about three million people through its outpatient facilities and eight member hospitals.