Collection of Blood, Body Fluid and Tissue Specimens From Healthy Donors for Use in In Vitro Research
Study Details
Study Description
Brief Summary
Increased numbers of white blood cells called eosinophils can cause disease. To investigate this disease, researchers need blood, urine, sputum, stool, cerebrospinal fluid, skin and/or bone marrow samples to compare to samples from patients with this problem. Some of the samples will be used for genetic testing or future research.
This study will last for about 10 years and will include a maximum of 50 paid volunteers ages 18 to 65.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
This protocol is designed to provide blood, urine, sputum, stool, cerebrospinal fluid, skin biopsy and bone marrow aspirate samples from paid, volunteer donors for use in in vitro studies of eosinophilia and parasitic diseases. Donors meeting standard normal donor eligibility criteria will be recruited to donate blood, urine, sputum, stool, cerebrospinal fluid, skin biopsy and/or bone marrow using conventional techniques. The investigational nature of the studies in which their samples will be used, as well as the risks and benefits of the donation process will be explained to all donors, and a signed informed consent document will be obtained. Donors will be compensated according to an established schedule based on the duration and discomfort of the donation. Samples provided through this protocol will be used solely for in vitro research. Blood, urine, sputum, stool, cerebrospinal fluid, skin biopsy and bone marrow samples will be assigned a unique product number, and the study investigators listed on this protocol will serve as the custodians of the code that links the product with a donor s identity. The nature of the in vitro studies in which the specimens collected in this study will be used is not the subject of this protocol and will be described in general terms only, since it involves several IRB-approved LPD protocols. Because some of these protocols require normal controls without a history of asthma or allergic disease, all subjects will undergo a standardized allergy/asthma history at enrollment. Serum immunoglobulin levels and a basic RAST panel may be performed on sera from some normal donors, and some normal donors may be asked to undergo pulmonary function testing. This protocol is designed to assure adequate and complete informed consent, counseling, and protection of the study subjects according to IRB, OHSR, OPRR and other applicable Federal regulatory standards.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy volunteer Healthy volunteer |
Outcome Measures
Primary Outcome Measures
- To provide an IRB-approved mechanism for the collection of peripheral blood, urine, sputum, stool, cerebrospinal fluid, skin biopsy and bone marrow samples from paid, volunteer donors for use in in vitro studies. [10 years]
To provide adequate and complete informed consent to the donors of research blood samples, and to assure that the education, counseling and protection of the study subjects from research risks is performed in accordance with IRB, OHRP, and other applicable Federal regulatory standards.
Eligibility Criteria
Criteria
- Eligibility criteria for volunteer whole blood donation are based on the Standards of the AABB(2) and the Code of Federal Regualtions 21 CFR 640(3). Specific criteria follow:
INCLUSION CRITERIA (blood, urine, stool and/or sputum donation):
-
ability to sign informed consent
-
healthy, male or female
-
18-85 years of age
EXCLUSION CRITERIA (blood, urine, stool and/or sputum donation):
-
pregnancy
-
weight <110 pounds
-
history of heart, lung, kidney disease, chronic anemia or bleeding disorders
Eligibility criteria for volunteer bone marrow, skin and cerebrospinal fluid donation are more stringent than those for other specimen donations to minimize risk of procedure complications and maximize utility of specimens for study:
INCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation):
-
ability to sign informed consent
-
healthy, male or female
-
18-85 years of age
-
willingness to provide concurrent blood sample
EXCLUSION CRITERIA (bone marrow, cerebrospinal fluid and/or skin donation):
-
a known bleeding disorder, low platelets (<100k) or taking medications that interfere with blood clotting, such as aspirin, non-steroidal antiinflammatory agents or warfarin
-
anemia (hemoglobin less than 12.3 mg/dL)
-
evidence of an immune deficiency, such as HIV infection or cancer
-
pregnancy
-
taking a medication that affects the immune response within the past month, including oral, intravenous, or injectable steroids
-
allergic to xylocaine
-
have taken an investigational drug in the last 6 months
-
any other medical condition that the investigator feels puts the participant at too high a risk for participation
-
warfarin and/or heparin treatment will not be stopped so that a subject can participate in this protocol. If warfarin or heparin was recently discontinued, a subject can be enrolled, but no bone marrow procedures will be performed until the PT is < 15.5 seconds and the PTT is within normal range. For other agents that interfere with blood clotting without prolonging the PT, a 7- day washout period will be required before bone marrow sampling, skin biopsy or lumbar puncture.
Additonal exclusion criteria (cerebrospinal fluid):
-Previous diagnosis of central nervous system pathology (including tumors,
inflammatory conditions, infection, seizure disorder, spina bifida)
-
History of spinal surgery with hardware placement
-
History of any spinal surgery or injections of the lumbosacral spine
-
Headache on the day of donation
Additonal exclusion criteria (skin biopsy):
-History of keloid or abnormal scar formation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
- Principal Investigator: Amy D Klion, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 040266
- 04-I-0266