Blood substitutes
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Blood Substitutes. Mara Atwood . Outline. Discovery of blood Important tasks of blood Why blood substitutes? Some current developments and products Risks and Benefits . Discovery of Blood Groups. [ 1]. (1868-1943 ) Karl Landsteiner (1901) Blood of two people under contact agglutinates

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Blood Substitutes

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Blood substitutes

Blood Substitutes

Mara Atwood


Outline

Outline

Discovery of blood

Important tasks of blood

Why blood substitutes?

Some current developments and products

Risks and Benefits


Discovery of blood groups

Discovery of Blood Groups

[1]

(1868-1943 ) Karl Landsteiner

(1901) Blood of two people under contact agglutinates

Due to blood serum (blood plasma)

Identified blood groups A, B, C (later named O)

(1907) First successful blood transfusion (Reuben Ottenberg, Mount Sinai Hospital, New York)


Principle tasks of blood

Principle Tasks of Blood

  • Transport Oxygen throughout body

    • Release oxygen to tissues – pick up carbon

    • Hemoglobin- Oxygen-carrying protein containing erythrocytes (Red Blood Cells)

  • White Blood Cells

    • Immune Response

  • Platelets

    • Blood Clotting, wound healing


  • Reasons for blood substitutes

    Reasons For Blood Substitutes

    • Human RBC have strict storage requirements

      • Designed to prolong clinical effectiveness, reduce risk bacterial infection

  • Blood Substitutes more amenable to sterilization

    • Do not require cross-matching

  • Donor Blood Shortages

    • Short-term replacement of blood during surgery


  • The ideal blood substitute

    The Ideal Blood Substitute

    Require no cross-matching, compatibility testing

    Suitable for long-term storage (room temperature)

    Survive circulation for several weeks (intravascular “dwell” time) before being cleared by kidney

    Side-effect free

    Free of pathogens

    Effectively deliver oxygen to tissues


    Current developments

    Current Developments

    Derived from Hemoglobin: Hemoglobin-based Oxygen Carriers (HBOCs)

    Those that use perfluorocarbon emulsions


    Hemoglobin based oxygen carriers

    Hemoglobin-Based Oxygen Carriers

    • Cell-free solution of hemoglobin as a blood substitute

      • Hemoglobin maintains ability to transport oxygen outside of red blood cells

  • Compatibility testing not required

  • Can be sterilized by ultrafiltration and low heat


  • Hemoglobin products

    Hemoglobin Products

    • Polyheme-polymerized human hemoglobin product

      • Northfield Laboratories

  • Hemopure-polymerized hemoglobin from bovine red blood cells

    • Biopure/Biotech

    • Approved in South Africa

    • Phase III clinical trials in U.S.

  • Hemolink-partially polymerized human hemoglobin

    • Hemsosol

    • Under FDA Review


  • Polyheme

    Polyheme

    Uses expired human blood

    Hemoglobin solution, no intact red blood cells

    Manufacturing steps reduce risk of viral infection

    Shelf life of 12 months

    Can be stored at room temperature

    Only provides oxygen carrying capacity

    Intravascular dwell time shorter than 120 days (RBC)


    Clinical trials

    Clinical Trials

    Finished Phase III trauma trial in June 2006

    December 19, 2006 preliminary results released

    13.2% died vs. 9.6% control group

    Re-evaluation of study database-no new trials

    Result: No FDA approval thus far


    Hemopure

    Hemopure

    • Developed by OPK Biotech

      • Based on chemically stabilized bovine (cattle) hemoglobin

  • Use in humans as oxygen delivering bridge when blood is not available

  • Stable for 36 months at room temperature

  • Compatible with all blood types


  • Hemopure1

    Hemopure

    Carried in the plasma

    Transports oxygen wherever plasma flows (partial blockages or constricted vessels)

    Holds same amount of oxygen as hemoglobin

    Release oxygen more readily

    Introducing Hemopure into bloodstream may help RBSc offload more oxygen to tissues than would otherwise.


    Clinical trials1

    Clinical Trials

    Last human test (date unknown) FDA imposed ban on further clinical trials due to safety concerns

    Animal testing has been ensued

    Hemopure approved for human use and commercial sale in South Africa in April 2001

    Result: No FDA approval thus far


    Hemolink

    Hemolink

    Developed by Hemosol

    Highly purified human hemoglobin-based oxygen carrier

    Approved for clinical trials in primary cardiac bypass surgery (early 2000s)

    Currently no FDA approval


    Perfluorocarbon

    Perfluorocarbon

    http://www.md.ucl.ac.be/virtanes/pastedoct99.html

    • Perfluorocarbons

      • Molecules structurally similar to hydrocarbons

      • Hydrogen atoms replaced with fluorine atoms

  • Perfluorocarbon Liquids have excellent capacity for carrying oxygen and carbon dioxide

  • Oxygen dissolves in chemically inert perfluorocarbon liquid

    • Can be easily extracted by oxygen-deprived tissue


  • Perfluorocarbon products

    Perfluorocarbon Products

    http://www.pharmaceuticalonline.com/doc/alliance-pharmaceutical-baxter-to-collaborate-0001

    • Fluosol DA

      • Approved by FDA as a blood substitute for heart surgery

      • Green Cross Corp. of Japan

      • (1989-1992) Used in more than 40,000 human subjects

      • Difficulty in storage and re-use-production ended

  • Oxygent

    • Developed by Alliance Pharmaceuticals

    • Stage II/III clinical trials

    • Study in 2008

    • As of February 2005, no FDA approval-safety


  • Risk vs benefit

    Risk Vs. Benefit

    • Safety of Donor Blood Supply

      • Risk of transfusion-associated HIV infection as low as 1 per 185,000

      • Risk of transfusion-associated infection of Hepatitis C Virus (HCV) between 1 per 300,000 and 1 per 600,000- compared to 1 per 103,000 in early 1990s

  • New blood substitutes could potentially carry unknown risks

  • Intravascular dwell times need to be increased

  • Cost needs to be competitive

  • Obtaining and processing sufficient amounts must be overcome


  • Thank you

    Thank You


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