Published monthly for CC employees by Clinical Center Communications/June
1997
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With the debut of its new cell processing facility, the Department of Transfusion Medicine (DTM) offers scaled-up manufacture of a broad range of components for cellular therapies such as gene therapy, hematopoietic (stem) cell transplantation, and immunotherapy. The 3,000-square-foot facility was built with the help of a cooperative research and development agreement with Baxter Healthcare Corporation. Goals are developing and improving procedures for collecting, modifying, growing, and preserving human cellular components. The lab caps more than a decade of support DTM has given investigators who seek novel cellular therapies. "We've been approached by just about every institute with ideas and plans for protocols for the next five to 10 years," said Dr. Elizabeth Read, cell processing section chief. "This facility was designed to meet the anticipated increased workload as well as the Food and Drug Administration's (FDA) regulatory requirements for a biologics production facility." A biologic is a treatment derived from a living organism, for example, a vaccine. The manipulation of human cellular and tissue-based products is receiving increased scrutiny by the FDA. In addition to manufacturing a variety of cell products (see sidebar at left below), the cell processing section is developing methods and devices to improve consistency and efficiency of processing, said Dr. Read. Automation, tracking, labeling, and equipment are all crucial to the process of manipulating billions of cells according to the specifications of many different protocols. "We are striving to provide a consistent product to the patient, despite all the complexity, so that the investigator will get the anticipated results and everybody will trust the data," she said. An ongoing pursuit that drives much of the research is to "close the system" of cell-product manufacture (see sidebar at right below). A closed system would be one in which the cellular products go from patient to lab and back to patient without being exposed to environmental contaminants. "It's possible we will always have some openness in our system," Dr. Read explained, "but our goal is to try to close things up because it significantly reduces the chances of microbial contamination." Thanks to DTM research, much of the cell processing is now done in plastic blood bags linked by plastic tubing. The lab sports a new $8,000 device that makes sterile welds between two pieces of tubing. "It's one of the stars of our show,"Dr. Read said. Environmental features in the spacious lab include a dedicated air-handling system, culture rooms for cell incubation, and easy-to-clean, dust-repellent surfaces. On June 16 from 9:30 to 11 a.m., members of the media will tour the new lab. By the end of this month, however, access will be restricted to maintain the lab's pristine environment. (by Sue Kendall) | ||
Attention clinical investigators: The cell processing section produces a wide variety of cellular products for NIH clinical trials. A few examples: For gene therapy: ·gene-transduced lymphocytes ·gene-transduced hematopoietic stem cells For hematopoietic therapy: ·hematopoietic stem cells from bone marrow or blood ·T-cell depleted hematopoietic stem cells For immunotherapy: ·peptide-pulsed antigen presenting cells ·peptide-activated lymphocytes |
Cell processing made simple: These basic steps are involved in most cell processing protocols. Thanks to years of DTM research, the process can largely be done with plastic tubing and blood bags to reduce microbial contamination. Apheresis: Removing a blood component from the patient, usually white blood cells, while returning the remainder of the blood to the patient or donor. Separation: Separating the cell type into subtypes by size, density, or other characteristic. Culture: Growing the cells under controlled conditions in the lab. Modification: Treating the cells in some way, e.g., introducing a corrective gene to give the cells a new function, or stimulating them with a growth factor. Expansion: A type of culture that greatly increases the number of cells. Reinfusion: Giving the processed cells back to the patient. In all clinical protocols, the patient is closely monitored for signs of disease improvement and side effects of the therapy. |
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Quilters stitch a testament of hope and understandingA double diagnosis of ovarian and breast cancer in 1995 and subsequent treatment at the Clinical Center led Susan Butler to search the internet for answers to the questions that kept her up at night. The support group she found in cyberspace gave her a forum to ask questions, share information, and spread hope and understanding to thousands of other women going through the ovarian cancer nightmare. Eventually, this meeting of the minds gave birth to the Ovarian Cancer Survivors' Quilt-brainchild of ovarian cancer survivor and quilter Shirlee Mohiuddin of Chicago. She, and fabric artist Nancy LeGendre of Massachusetts, created a 6-foot-by-6-foot quilt of individual squares made by ovarian cancer patients and caregivers from around the country. When Butler suggested they present the quilt at an NIH ceremony she was asked by the many participants how she could get the attention of such a large institution. She answered, "I'll get their attention, because I think they'll care." Publicized on the ovarian cancer discussion list on the internet in the spring of 1996, the quilt was recently unveiled at the Clinical Center. Among ceremony attendees were other ovarian cancer patients and families of patients; NCI physicians Dr. Eddie Reed and Dr. Elise Kohn; Dr. Charles Rabson, NCI deputy director; and Dr. Vivian Pinn, director of the Office of Research on Women's Health. Butler, Mohiuddin, and LeGendre met face to face for the first time at the presentation. After hanging in the CC lobby for a month, the quilt will begin a journey to other health research and teaching centers to encourage ovarian cancer patients and to raise awareness about this often silent disease and the need for more research funding. (by Laura Bradbard) |
news briefs:Board meeting set for July 10The Clinical Center Board of Governors will meet at 9 a.m. on July 10 in the Medical Board Room. The group is expected to consider the CC budget for the next fiscal year and review priorities for the Clinical Center's strategic plan. At the board's last meeting, which was Feb. 10, members endorsed the Clinical Center's strategic plan and asked that the institutes be given an opportunity to comment on priorities for the plan's individual projects. Piscitelli honoredDr. Stephen Piscitelli, CC Pharmacy Department, has received the 1997 American College of Clinical Pharmacy-Amgen Biotechnology Research Award for his proposal, "Drug-Cytokine Interaction in HIV-Infected Patients." The award will be formally presented during ACCP's annual meeting later this year in Phoenix. Ceremonies honor CC volunteersCeremonies were held recently to honor the Clinical Center's volunteers. Receiving pins for 1,000 hours of service were Elaine Brill, Harry Canter, Amparo Collazo, Mary Maze, Mary Partlow, and Louise Shiffrin. Honored with pins for 2,000 hours service were Susan Canter, Catherine Freedberg, and Susan Schap. Pins for 3,000 hours of service were presented to Dorothy Feelemyer, Ganesh Kayastha, and Amanda Modlin. Special recognition went to Floride Canter for 8,000 hours of volunteer service. Canter was also recently honored as Montgomery County's Red Cross volunteer who has contributed the most hours of service. Training vouchersThe education and training section, Office of Human Resources Management, has purchased vouchers from CompUSA for CC employees to use for computer training at no cost to their department's training budget. CompUSA offers a variety of Mac, PC, and internet courses at training sites in Maryland and Virginia. On-site courses (Mac only) will offer fundamental and intermediate training in MSWord, Excel, and Powerpoint during May and June at 6100 Executive Boulevard. Call 496-1618 for details. Vouchers must be used by June 26. |
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| Clinical Center News, Building 10, Room 1C255, National Institutes of Health, Bethesda, Maryland 20892. (301) 496-2563. Fax: 402-2984. Published monthly for CC employees by the Office of Clinical Center Communications, Colleen Henrichsen, chief. News, articles ideas, calendar events, letters, and photographs are welcome. Deadline for submission is the second Monday of each month. Editor: Sara Byars, sbyars@nih.gov. Staff Writers: Laura Bradbard, Sue Kendall. |