News and Publications

General Clinical Research Center

Frank V. Chisari, M.D.

E. Beutler, F.V. Chisari, B.L. Zuraw, D.R. Salomon, J.A. Koziol, D.A. Gilder, S.L. Mirkis, C.V. Grininger, K.H. Cox, E.A. Bieger

Established in 1974 with a generous gift from Mrs. William H. Black and Mr. and Mrs. William F. Black, and later supplemented by a donation from the Stein Endowment Fund, the General Clinical Research Center (GCRC) is in its 28th year of continuous operation. Financed by a grant of about $2 million annually from the National Center for Research Resources, National Institutes of Health, to provide facilities for investigator-initiated, peer-reviewed research with human subjects, the GCRC is the only one of 77 such centers in the United States that is not affiliated with a university or a medical school. The GCRC aims to augment investigative collaborations among the clinicians and researchers at Scripps to facilitate the transfer of basic knowledge generated in research laboratories to the clinical arena, to elucidate pathogenetic mechanisms of disease, and to evaluate new modes of patient management.

The GCRC provides inpatient and outpatient environments in which investigators conduct studies in humans; the protocols are approved for safety by the Human Subjects Committee and for scientific merit by the GCRC Scientific Advisory Committee. The GCRC grant pays many of the costs of this research. GCRC facilities include a highly trained research nursing staff in a discrete nursing unit in the Scripps Green Hospital. A fully staffed core laboratory provides technical support for specialized research assays; preparation and storage of specimens; samples of normal blood for the laboratories of TSRI; and a DNA/RNA tissue bank, established in cooperation with the Department of Surgery.

In addition, the GCRC operates a computer center for the management of clinical data, genetic sequencing, and other statistical needs. Additional staff include a biostatistician for consultation on study design and statistical analysis and professional and administrative personnel to help with study design, preparation of protocols, and budgetary matters.

Last year, the GCRC provided these services for about 4600 outpatient visits, processed about 9730 specimens, and supported several computer-based research protocols from TSRI and Scripps Clinic Medical Group. Forty-nine patient-related research protocols were carried out in the GCRC; the titles and principal investigators of most of them are listed at the end of this report. Many of these projects are described under the names of the individual investigators elsewhere in this volume. A total of 57 investigators made use of the GCRC facilities last year.

INVESTIGATOR PROTOCOL TITLE

Ernest Beutler, MD Epidemiologic Studies of Hemochro-matosis and the Creation of an Anonymized DNA Database

Dennis R. Burton, PhD Human Antibodies to Infectious Agents

Francis Chisari, MD Immunobiology and Pathogenesis of Hepatitis

Cindy Ehlers, PhD EEG Markers of Alcoholism Risk

Cindy Ehlers, PhD Response to Ethanol in Asian-, African-, and Native Americans

Mary Jo Heeb, PhD Forms of Prostate-Specific Antigen and hK2 in Cancer

Lawrence Kline, DO DPAP for Obstructive Sleep Apnea

Thomas Kunicki, PhD Relationship Between Membrane Density of a₂b₁ Integrin and CAD

Martin Lotz, MD Mesenchymal Stem Cells in the Pathogenesis of Arthritis

Nigel Mackman, PhD Establishment of a New Assay to Measure Tissue Factor Activity in Whole Blood

James R. Mason, MD Dose Escalation of Anti-CD33 x Humanized Murine Anti-FcgRI Bispecific Antibody in Relapsed AML

David A. Mathison, MD Genomic and Molecular Determinants of Airway Hyperreactivity in Human Asthma

John McHutchison, MD Intron A and Alferon-N for Hepatitis C

Robert McMillan, MD Treatment of Chronic ITP

Donald E. Mosier, MD, PhD Coreceptor Usage and HIV Disease Kinetics

Michael B.A. Oldstone, MD Long-term Immunity After Childhood Measles Vaccination in the Presence or Absence of Circulating Measles

Michael B.A. Oldstone, MD Characterization of Myelin-Specific Immune Response as an Indicator of Disease State in Multiple Sclerosis

J. Steven Poceta, MD Sleep and Alertness in Parkinson's and Restless Legs: Dopaminergic Mechanisms

Paul Pockros, MD Studies of Interferon in Hepatitis B and Hepatitis C

Pascal Poignard, MD Viral Evasion and HIV Entry-Blocking Strategies

Zaverio M. Ruggeri, MD Mechanisms of Platelet Thrombus Formation

Daniel R. Salomon, MD Normal Blood-Drawing for TSRI Labs

Jack Sipe, MD Cladribine (2-CdA) Treatment of Multiple Sclerosis

Donald Stevenson, MD Analgesic Desensitization in Aspirin-Sensitive Asthma

Andrea Suhner, PhD Melatonin and Estrogen Therapy in Perimenopausal Sleep Dysfunction

Bruce Zuraw, MD Angioedema and Hageman Factor

Bruce Zuraw, MD Functional Consequences of B₁ BK Receptor Expression During Allergic Airway Inflammation