Table 1.
Biocompatibility of Chemically Synthesized and Recombinant Elastin-Mimetic Polypeptides
| Recombinant Elastin-Mimetic | Assay | Reported Results | Testing Comments |
|---|---|---|---|
| Chemically synthesized Poly (VPGVG) | Ames mutagenicity test | Non- mutagenic | Test samples were determined as innocuous as negative controls 55 |
| Chemically synthesized Poly (VPGVG) | Cytotoxicity-agarose overlay | Non-toxic | No evidence of fibroblast cell death or lysis following incubation for 24 hours 55 |
| Chemically synthesized Poly (VPGVG) | Acute systemic toxicity | Non-toxic | No difference in IV injections of 24 hour extracts of gamma irradiated sheets of poly(VPGVG) and control extracts 55 |
| Chemically synthesized Poly (VPGVG) | Intracutaneous toxicity | Non-toxic | No erythema or edema was observed at injection site after 24, 48, and 72 hours 55 |
| Chemically synthesized Poly (VPGVG) | Muscle implantation | Favorable at 7 days | Needle injection of film fragments, material was a ‘slight irritant’ as compared to the negative control 55 |
| Chemically synthesized Poly (VPGVG) | Acute intraperitoneal toxicity | Non-toxic at 4 weeks | Recovered implants were reported as ‘very similar to pre-implant condition’ 55 |
| Chemically synthesized Poly (VPGVG) | Systemic antigenicity study | Non-antigenic | No anaphylactic signs from IP injections three times a week, every other day, for 14 and 21 days 55 |
| Chemically synthesized Poly (VPGVG) | Dermal sensitation | Non- sensitizing at 7 days | Intradermal injections were challenged with solutions to provoke a mild acute inflammation at injection site, but ‘showed no significant evidence of causing dermal sensitization 55 |
| Chemically synthesized Poly (VPGVG) | Pyrogenicity | Non-pyrogenic | IV injection into rabbit ear vein and temperature of the animals were monitored 55 |
| Chemically synthesized Poly (VPGVG) | Lee White Clotting Study | Normal clotting time | Used canine blood, all clotting times were within normal ranges for dog 55 |
| Chemically synthesized Poly (VPGVG) | In vitro hemolysis test | Non-hemolytic | 0% hemolysis reported for rabbit blood determined spectrophotometrically 55 |
| Chemically synthesized Poly (VPGVG) | Bone implantation | No calcification or ossification | Fibrous granulation tissue, no calcification or ossification at 3 weeks 54 |
| Chemically synthesized Poly (VPGVG) | IM implantation | No calcification or ossification | Fibrous tissue capsule with a medium range of active phagocytic cell infiltration at muscle site with no evidence of calcification or ossification, reported as ‘passive tissue reaction similar to those found for biodegradable suture materials at three weeks 54 |
| Microbially expressed triblock | Baboon arteriovenous shunt model | Non-thrombogenic | Minimal fibrin and platelet deposition over a 1 hour time period of elastin-mimetic impregnated PTFE graft 19 |
| Chemically synthesized Poly (VPAVG) | Subcutaneous injection | Non-inflammatory | Edema was measured after microparticle injection at 24 hours in a hind paw injection model 56 |
| Chemically synthesized Poly (VPAVG) | Intraocular injection | Non-inflammatory | 28 days post-injection displayed minimal signs of inflammation, though tractional retinal detachment was observed with fibroblastic activity 56 |
| Microbially expressed poly VPGVG (aggregating) and VPGAG (non- aggregating) | Intra-articular injection | Biodegradable | Protein remained in joint for 2 (non-aggregated protein) to 30 days (aggregated protein) 61 |
| Microbially expressed human tropoelastin | Subcutaneous implant | Well tolerated | Uniform encapsulation with minimal to moderate inflammation at 13 weeks 62 |