Pre-clinical studies

BioActive Polymer’s BioBarrier™ has been examined in multiple pre-clinical studies. The following is a list of the published findings of these studies.

Bauden M, Isaksson K, Åkerberg D, Andersson R, Tingstedt B.
Novel anti-adhesive barrier BioBarrier reduces growth of colon cancer cells.  Journal of Surgical Research, Published online 11 April 2014

In vitro and in vivo studies showing that BioBarrier may be effective in reducing intra-abdominal tumor cell implantation and subsequent tumor development in conjunction with peritoneal trauma in a syngeneic rat model.

Isaksson K, Akerberg D, Posaric-Bauden M, Andersson R, Tingstedt B.
In vivo toxicity and biodistribution of intraperitoneal and intravenous poly-L-lysine and poly-L-lysine/poly-L-glutamate in rats. J Mater Sci Mater Med. 2014 Jan 22.

Animal study elucidating toxic mechanisms of polylysine administered without polyglutamate showing effect on vascular endothelial cells.
Furthermore this work shows the biodistribution of large molecular polylysine administered with and without polyglutamate, intravenously as well as intraperitoneally.

D. Åkerberg, M. Posaric-Bauden, K. Isaksson, R. Andersson, B. Tingstedt.
Prevention of Pleural Adhesions by Bioactive Polypeptides – A Pilot Study. Int J Med Sci 2013; 10(12):1720-1726. doi:10.7150/ijms.6651.

Pilot study of BioBarrier as adhesion prevention after thoracic surgery. Significant decrease in postoperative adhesions and less fibrosis in histology after using BioBarrier.

Åkerberg D, Posaric Bauden M, Isaksson K, Andersson R and Tingstedt B.
Prevention of Adhesions by PL/PG after Adhesiolysis. J Tissue Sci Eng 2012, 3:4.

This work confirms that PL/PG may be used to prevent adhesion formation after adhesiolysis. The process of fibrinolysis and fibrosis was not affected, after PL/PG prophylaxis and adhesiolysis.

Åkerberg D, Isaksson K, Posaric- Bauden M, Andersson R, Tingstedt B. 
Effects of polylysine and polyglutamate on inflammation and the normal process of peritoneal healing after surgery. J Tissue Sci Eng 2012; 3: 117.

Time-dynamic study on the effect of polypeptides on adhesions, healing and fibrosis/fibrinolysis showing no difference against control animals.

Åkerberg D, Grunditz C, Posaric- Bauden M, Isaksson K, Andersson R, Tingstedt B. 
The Influence on abdominal adhesions and inflammation in rabbits after exposure to differently charged polypeptides. JBiSE 2012; 5: 432-38.

Evidence of effect using spray application of polypeptides. Furthermore this study shows no impact on key parameters of inflammation and fibrosis.

Isaksson K, Åkerberg D, Said K, Tingstedt B.
Cationic polypeptides in a concept of oppositely charged polypeptides as prevention of postsurgical intraabdominal adhesions . J. Biomedical Science and Engineering 2011; 4: 200-206.

Evaluation of different cationic polypetides regarding toxicity and different antiadhesive responses.

Isaksson K, Åkerberg D, Andersson R, Tingstedt B.
Toxicity and dose-response of intraabdominally administered α-poly-l-lysine and poly-l-glutamate for postoperative adhesion protection. Eur Surg Res. Eur Surg Res. 2010; 44: 17-22.

This work establishes the lowest effective dose of the BioBarrier™ and handles the toxicity of very high doses of the cationic polypeptide poly-L-lysine.

Tingstedt B, Nehez L, Lindman B, Andersson R.
Efficacy of bioactive polypeptides on bleeding and intraabdominal adhesions. Eur Surg Res 2007;39:35-40.

In a parenchymal bleeding model with severe injury to the liver and spleen the BioBarrier™ reduces bleeding by sealing the injury. This is also measured after 4 weeks as a decreased amount of collagen depositions indicating a decreased inflammatory response.

Tingstedt B, Nehez L, Lindman B, Andersson R.
Effect of bioactive polypeptides on insufficient large bowel anastomoses in the rat. J Invest Surg 2007; 20:229-235.

Even if the bowel anastomoses are leaking the BioBarrier™ offers some protection against leakage while still showing antiadhesive properties. BioBarrier also indicates that it can seal smaller holes in the intestines.

Tingstedt B, Nehez L, Axelsson J, Lindman B, Andersson R.
Increasing anastomoses safety and preventing abdominal adhesion formation by the use of polypeptides in the rat. Int J Colorectal Dis 2006;21:556-572.

This study implicates increased safety of bowel anastomoses using BioBarrier™ measured as burst-pressure while still exercising an antiadhesive effect. Microscopy shows perfectly healed anastomoses after 8 weeks.

Nehez L, Tingstedt B, Axelsson J, Andersson R.
Differently charged polypeptides in the prevention of post-surgical peritoneal adhesions. Scand J Gastroenterol 2007;42:519-523

This work evaluates different sized cationic polypeptides as the cationic part of the BioBarrier™.

Nehez L, Tingstedt B, Vödrös D, Axelsson J, Lindman B, Andersson R.
Novel treatment in peritoneal adhesion prevention: protection by polypeptides. Scand J Gastroenterol 2006;41:1110- 1117.

This study evaluates the concept of polypeptides as an antiadhesive measure. The results outline the best combination being a combination of an anionic and a cationic polypeptide. Furthermore it was shown that there was no negative impact on the peritoneal macrophages using the combination of polypeptides.

Nehez L, Vödrös D, Axelsson J, Tingstedt B, Lindman B, Andersson R.

Prevention of postoperative peritoneal adhesions: effects of Iysozyme, poly-lysine and poly-glutamate vs. hyaluronic acid. Scand J Gastroenterol 2005;40:1118-1123.

Further evaluation of the concept showing biocompatibility of the BioBarrier™ to peritoneum using fluorescence and electromicroscopy as well as showing no impact on macrophage function.