Gelatin-transglutaminase hemostatic dressings and sealants
An adhesive material for medical use comprising gelatin and a non-toxic cross-linking material such as transglutaminase. An optional embodiment of the invention includes dressings in which a layer of a transglutaminase is sandwiched between a first and second layer of gelatin. The hemostatic products are useful for the treatment of wounded tissue.
1. A hemostatic or body fluid sealing agent wherein said agent comprises a composition of gelatin and a transglutaminase composition wherein said transglutaminase composition has a specific gelatin crosslinking activity of from 40U to 200 U/gm of gelatin and in which the weight ratio of gelatin to transglutaminase composition is in a range of from 1:1 to 300:1; such that said agent when applied to a wound site cross links between gelatin chains and endogenous collagen of tissue extracellular matrix to create a barrier to fluid leakage or bleeding.
2. The agent according to claim 1 , wherein said transglutaminase composition comprises a plant, recombinant, animal, or microbe derived transglutaminase other than blood derived Factor XIII.
3. The agent according to claim 1 , wherein said animal origin is selected from the group consisting of fish and mammals.
4. The agent according to claim 1 , wherein said microbial derived transglutaminase is isolated from one or more of Streptoverticillium aldaccii, Streptomyces hygroscopicus , or Escherichia coli.
5. The agent according to claim 1 , wherein said composition has a pH in a range of from 5 to 8.
6. The agent according to claim 1 , further comprising a stabilizer or a filler.
7. The agent according to claim 1 , wherein gelatin is purified to remove salts and wherein said transglutaminase composition comprises a recombinant or animal derived transglutaminase.
8. The agent according to claim 1 , wherein said agent induces hemostasis or stasis of other leaking bodily fluids in said tissue.
9. The agent according to claim 1 wherein bodily fluid is selected from the group consisting of blood, cerebral spinal fluid, intestinal fluid, air, bile, and urine.
10. The agent according to claim 1 , wherein said agent induces the formation of a biomimetic clot at a site of a damaged blood vessel.
11. The agent according to claim 1 , wherein said wounded site is selected from the group consisting of surgically cut tissue and traumatized tissue.
12. A hemostatic or body fluid sealing agent wherein said agent comprises a composition of gelatin and a transglutaminase composition wherein said transglutaminase composition has a specific gelatin crosslinking activity of from 40U to 200 U/gm of gelatin for use in the treatment of wounded tissue, and in which the weight ratio of gelatin to transglutaminase composition is in a range of from 1:1 to 300:1.