A totally recombinant human fibrin sealant

Area of Science:

• Biotechnology
• Biomaterials
• Surgical Hemostasis

Background:

• Plasma-derived human fibrin sealants (pdhFS) face limitations in supply, cost, and pathogen safety.
• Bioengineering offers a path to overcome these limitations for improved fibrin sealant applications.

Purpose of the Study:

• To develop and evaluate a totally recombinant human fibrin sealant (rhFS) as a potential alternative to pdhFS.
• To assess the hemostatic efficacy and characteristics of rhFS compared to commercial pdhFS.

Main Methods:

• A first-generation rhFS was formulated using recombinant human fibrinogen, activated recombinant human factor XIII, and recombinant human thrombin.
• Thromboelastography (TEG) was used for in vitro analysis of clot strength and kinetics.
• Hemostatic efficacy was evaluated in a porcine hepatic wedge excision model.

Main Results:

• rhFS exhibited maximal clot strength comparable to pdhFS in vitro.
• rhFS demonstrated faster clot formation kinetics (steeper α angle) with significantly lower factor I content.
• In vivo, rhFS achieved equivalent or superior hemostatic scores compared to pdhFS in the porcine model.

Conclusions:

• Bioengineered rhFS possesses equivalent or superior hemostatic efficacy to pdhFS.
• rhFS offers potential advantages in terms of abundance, cost-effectiveness, and reduced risk of pathogen transmission.
• This recombinant sealant represents a promising advancement for surgical hemostasis.