CELL THERAPY: Engineered Cell "Pharmacy" Opens

Applied Genetics News,  April, 2002  

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Last month, Rush-Presbyterian-St. Luke's Medical Center (1650 Harrison St., Chicago, IL 61612; Tel: 312/942-5000; Website: www.rush.edu) in Chicago opened a new laboratory facility that will produce and dispense engineered cellular products that harness a cancer patient's own immune system to fight cancer. The Sramek Center for Cell Engineering is already running two Food and Drug Administration-approved Phase I/II safety trials designed for patients with renal cell melanoma and lymphoma.

The Elmer and Sylvia Sramek Charitable Foundation has awarded more than $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 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," says Klingemann. "Immunotherapy- using the patient's own cells to treat cancer-is increasing and has proven to be very successful."

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," says Richard Meagher, 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 treatments to be studied will be therapy with NK- 92 cells, a 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 preclinical cancer trials with mice.

Another 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 bioreactor contains special nutrients and growth factors 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 2 to 3 wk. 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 markers or tumor antigens on their surface that are recognized by T-cells. 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.

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