NIH Clinical Research Studies

Protocol Number: 07-E-0023

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Title:
Innate Immunity Signal Transduction in Human Leukocytes
Number:
07-E-0023
Summary:
This study will investigate the response of immune cells (neutrophils, monocytes) to various signals in the test tube to determine how they sense the signals in the body and what substances they produce in response to them. It will determine how the cells may, under certain circumstances, contribute to inflammation, and will measure substances in the blood plasma (the liquid, non-cellular part of the blood) that might stimulate white blood cells, in order to understand how the blood responds to possible disease-related conditions.

Healthy normal volunteers 18 years of age and older who weigh at least 110 pounds may be eligible for this study. Participants give about 320 milliliters (mL) of blood (about 1 1/3 cups) or less at each donation. They donate no more than once every 8 weeks and no more than six times a year. On some occasions, less than 320 mL of blood may be drawn. The collected blood is separated into its components and specific cells are exposed to substances to examine their response.

Sponsoring Institute:
National Institute of Environmental Health Sciences (NIEHS)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Normal, healthy adult donors as judged by screening questionnaire.

Nonpregnant.

Weighing at least 110 pounds.

HIV negative (proof required every 6 months - we will conduct the test).

Hepatitis B surface antigen and hepatitis C serology negative (checked every 6 months - we conduct test).

Aged 18-65 years of age.

EXCLUSION CRITERIA:

By questionnaire:

Feeling ill within the last 24 hours.

Alcohol consumption in the last 24 hours.

Visit to the dentist in the last 24 hours.

A doctor visit for illness or vaccination in the last 2 weeks.

Diarrhea in the last 2 weeks.

Recurrent fever (4 weeks).

Pregnant or suspected pregnancy in the last 6 weeks.

Blood or plasma donation in the last 8 weeks.

Receiving a blood donation in the past 12 months.

Bleeding disorder.

Anemia.

Heart problems.

Insulin dependent diabetes.

Problems with blood donation.

Risk of or evidence of Creutzfeldt-Jacob Disease in the family.

HIV-positive status.

Hepatitis B/C positive status.

Selected medications within the preceding 5 days (NSAIDS/aspirin/Tylenol, antidepressants, antihistamines, corticosteroids, HMG CoA reductase inhibitors, and antihypertensives).

By exam:

Temperature over 99.5 F.

Blood pressure less than 90/50.

Blood pressure higher than 170/95 mm Hg.

Pulse rate less than 50 or greater than 100 beats/minute.

Hematocrit less than 34% for women or less than 36% for men, or greater than 56% for either gender.

Special Instructions:
Currently Not Provided
Keywords:
Neutrophil
Immunity
Signal Transduction
Lipopolysaccharide
Cholesterol
Recruitment Keyword(s):
Healthy Volunteer
HV
Condition(s):
Healthy
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Environmental Health Sciences

Contact(s):
Kathleen A. Smoak, Ph.D.
National Institute of Environmental Health Sciences
Bldg 101, E-253
P.O. Box 12233
Research Triangle Park, NC 27709
Phone: (919) 541-1931
Fax: Not Listed
Electronic Address: smoak@mail.nih.gov

Citation(s):
Walker TS, Tomlin KL, Worthen GS, Poch KR, Lieber JG, Saavedra MT, Fessler MB, Malcolm KC, Vasil ML, Nick JA. Enhanced Pseudomonas aeruginosa biofilm development mediated by human neutrophils. Infect Immun. 2005 Jun;73(6):3693-701.

Fessler MB, Arndt PG, Frasch SC, Lieber JG, Johnson CA, Murphy RC, Nick JA, Bratton DL, Malcolm KC, Worthen GS. Lipid rafts regulate lipopolysaccharide-induced activation of Cdc42 and inflammatory functions of the human neutrophil. J Biol Chem. 2004 Sep 17;279(38):39989-98. Epub 2004 Jul 15.

Frasch SC, Henson PM, Nagaosa K, Fessler MB, Borregaard N, Bratton DL. Phospholipid flip-flop and phospholipid scramblase 1 (PLSCR1) co-localize to uropod rafts in formylated Met-Leu-Phe-stimulated neutrophils. J Biol Chem. 2004 Apr 23;279(17):17625-33. Epub 2004 Feb 6.

Active Accrual, Protocols Recruiting New Patients

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