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Related Experiment Videos

Two years' experience with two recombinant factor VIII concentrates

H H Brackmann1, E Aygören, I Scharrer

  • 1Institute of Experimental Haematology and Transfusion Medicine, University of Bonn, Germany.

Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis
|June 1, 1993
PubMed
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Recombinant coagulation factor concentrates, like Recombinate and Kogenate, show good clinical efficacy for hemophilia patients. These treatments, used for prophylaxis and bleeding episodes, had no serious side effects in trials.

Area of Science:

  • Biotechnology
  • Hematology
  • Infectious Disease Control

Background:

  • Plasma-derived factor concentrates carry a risk of infectious disease transmission.
  • Recombinant DNA technology offers a safer alternative for producing coagulation factors.

Purpose of the Study:

  • To evaluate the clinical efficacy and safety of two recombinant factor VIII concentrates.
  • To compare recombinant factor VIII concentrates with plasma-derived concentrates in hemophilia treatment.

Main Methods:

  • Clinical trials involving twelve hemophilia patients.
  • Administration of 4.1 million IU of recombinant factor VIII concentrates (Recombinate and Kogenate) for prophylaxis and bleeding treatment.
  • Monitoring for clinical efficacy, allergic reactions, inhibitor development, and other adverse events.

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  • Laboratory investigations to assess safety.

    • Main Results:

    • Good clinical efficacy in treating bleeding episodes, comparable to plasma-derived concentrates.
    • No allergic reactions or development of inhibitors were observed.
    • No serious side effects or adverse laboratory findings were encountered.

    Conclusions:

    • Recombinant factor VIII concentrates are a safe and effective alternative to plasma-derived concentrates for hemophilia management.
    • The use of recombinant DNA technology in manufacturing factor concentrates significantly reduces the risk of infectious disease transmission.