RedCross Request Jerome H. Holland Laboratory is collecting small volumes of blood from patients afflicted with various forms of
Posted Aug 18 2012 3:58pm
RedCross Request Jerome H. Holland Laboratory is collecting small volumes of blood from patients afflicted with various forms of transmissible spongiform encephalopathies (TSE)/prion diseases and their blood-related family members 2012
UPDATED INFORMATION AUGUST 2012
The American National Red Cross (Red Cross) Jerome H. Holland Laboratory for Biomedical Research in Rockville, Maryland is collecting small volumes of blood from patients afflicted with various forms of transmissible spongiform encephalopathies (TSE)/prion diseases and their blood-related family members. The purpose of the research is to build a blood sample repository for studies on ways to detect the presence of prion protein or other markers of the disease in human blood.
Recent epidemiological evidence indicates that blood of patients with variant form of Creutzfeldt-Jakob disease (vCJD), that is prevalent in the United Kingdom, is infectious.
The questions about the possibility that blood from patients with the sporadic and familial forms of TSE might also be infectious is still not resolved even though 10 years of searching has not revealed any examples of blood-related transmission from patients with these non-variant forms of disease.
The development of a blood test to identify affected people in the pre-clinical stage of disease could eliminate the uncertainty about TSE-related blood safety. Some tests have been successful for testing animals infected with TSEs, but in order to know if any test will be reliable in humans, we need to test human blood.
CJD patients and their families are the only source of blood specimens that can answer this question, and we therefore ask you to support our effort.
If you or an affected relative is interested in participating, please contact the name listed below. No more than 50 ml of blood should be collected at a location convenient to you through your own arrangements with your physician and the blood sample should be sent to the Holland Laboratory at no cost to you. The samples will be processed and stored, frozen indefinitely, at the Holland Laboratory in Rockville, Maryland. The Red Cross will provide access to only designated research staff at the Red Cross or other research groups that have provided convincing evidence for a test to detect TSE in animals.
Participating individuals will NOT be notified about test results because the tests that will be performed on blood are experimental and their significance is not known and will remain uncertain for some years to come. The CJD foundation will be notified of any publications coming from our research.
Dr. Larisa Cervenakova; Phone: 301-738-0765; e-mail: email@example.com
CHAIRMAN BROWN: My name is Dr. Paul Brown. Welcome to the FDA traveling road show. We are asked yet once more by the FDA to consider a question of theoretical risk in the absence of sufficient knowledge on which to base any firm conclusion. The issue before us today is that of excluding categories of American blood donors who have either visited or resided for longer periods of time in Great Britain. The issue is sufficiently delicate, as you see that we have been moved outside the Beltway. (Laughter.)snip... "Dr. Alan Williams is employed by the American Red Cross, Holland Labs,and is Scientific Adviser for the Florida Blood Services and Canadian Blood Services. In addition, he has financial interests in firms that could be affected by the general discussions. "Dr. Richard Race has financial interests in firms that could be affected by the general discussions and is a public health science researcher. "In the event that the discussions involve specific products or specific firms for which FDA participants have a financial interest, the participants are aware of the need to exclude themselves from such involvement. And their exclusion will be noted for the public record. A copy of the waivers is available by written request under the Freedom of Information Act. "With respect to all other meeting participants, we ask in the interest of fairness that they address any current or previous financial involvement with any firm whose product they may wish to comment upon." So ends the reading of the conflict of interest statement. Dr. Brown, I turn the meeting over to you.snip...
Guidance for Industry Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products”