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Factor VIII and transmissible spongiform encephalopathy: the case for safety
L Cervenakova1, P Brown, D J Hammond
1J. Holland Laboratory, American Red Cross, Rockville, MD 20855, USA. cervenak@usa.redcross.org
Summary
This review examines the risk of prion disease transmission via clotting factor treatments for hemophilia A. It assesses potential TSE risks associated with both plasma-derived and recombinant factor VIII therapies.
Area of Science:
- Hematology
- Neurology
- Infectious Diseases
Background:
- Hemophilia A is a prevalent inherited bleeding disorder due to Factor VIII (FVIII) deficiency.
- Current treatments involve FVIII concentrate infusions, derived from plasma or recombinant sources.
- Production of FVIII concentrates may involve materials exposed to human or animal sources.
Purpose of the Study:
- To review studies on blood infectivity concerning transmissible spongiform encephalopathies (TSEs).
- To evaluate the potential risk of TSE transmission through FVIII treatments.
- To assess risks associated with both plasma-derived and recombinant FVIII.
Main Methods:
- Systematic review of epidemiological studies.
- Analysis of experimental research on TSE infectivity.
- Evaluation of hypothetical TSE transmission risks in FVIII therapy.
Main Results:
- The review synthesizes current knowledge on TSEs and blood infectivity.
- It specifically addresses the theoretical possibility of TSE transmission via FVIII concentrates.
- Both plasma-derived and recombinant FVIII treatment modalities are considered.
Conclusions:
- The study provides an assessment of the TSE transmission risk associated with hemophilia A treatments.
- It highlights the importance of understanding potential risks in FVIII therapy.
- Further research may be needed to fully elucidate and mitigate these risks.