The study demonstrated the outstanding performance of CardioCel® in the reconstruction of heart valves compared to the control, and notably that valves in the CardioCel® repaired group demonstrated significantly reduced calcification versus the control as well as minimal thickening of the tissue.
The histology data showed that after eight months there had been significant new tissue growth on both sides of the implanted CardioCel® patch, consisting of collagen and several different cell types, which are typically found in a healthy cardiovascular healing process as well as in heart valves.
In the study there was no evidence of macroscopic calcification of the CardioCel® implant on echocardiography (heart ultrasound) and in molecular measurement of extractable calcium, the active CardioCel® tissue had 40% less calcium than the control native autologous tissue.
“These results are remarkable, particularly regarding evidence that the CardioCel® patch material appears to enable tissue regeneration, opening up the possibility for CardioCel® treated valves to regenerate without additional intervention or assistance,” said Lee Rodne, Allied Healthcare Group Managing Director.
“The demonstration of effective tissue regeneration without adding external stimulation like stem cells or growth factors is a major new finding from this study.”
The histology results were independently assessed by Prof. Frederick J. Schoen, M.D., Ph.D, Executive Vice-Chairman, Department of Pathology, Brigham and Women's Hospital and Professor of Pathology and Health Sciences and Technology (HST), Harvard Medical School. Calcification levels were independently quantified by the Murdoch University research group.
In his conclusion, Prof Frederick J. Schoen said, "No apparent significant adverse effects were present. Based on the experience in the present study, CardioCel® pericardium appears to be a suitable bioprosthetic substitute for valve reconstruction procedures and consideration as an alternative to autologous pericardium.”
“As well as tissue regeneration, further evidence of the lack of calcification in the CardioCel® tissue is very encouraging. Reduced calcification should result in the reduction of repeat surgeries, and therefore the reduction in unnecessary patient risk, stress and cost, promoting a lifelong solution for patients. These results provide further support to the importance and benefits of CardioCel® in the area of tissue repair, reconstruction and regeneration,” said Bob Atwill, Allied Executive and CEO of the Regenerative Medicine Franchise.
The study was undertaken in collaboration with paediatric cardiac surgeon Professor Christian Brizard, from The University of Melbourne.
The CardioCel® scaffold appears to attract endogenous stem cells which allow “normal” cell growth, proliferation and differentiation into fully functional valve tissue. Current research indicates that a tissue matrix becomes incorporated into native tissue over time. These study results show that CardioCel® becomes enveloped with endothelial cells via normal cell growth, suggesting it is ‘invisible’ to the recipient immune system and becomes native tissue over time.
These results expand the potential for CardioCel® and open up opportunities to develop additional ADAPT® engineered tissue products. The independent validation of these latest results confirms the regenerative performance of the ADAPT® treated tissue and provides an opportunity to transform valve reconstructive surgery, along with expanding opportunities in congenital heart disease repair surgery.
“These regenerative results, in one of the most challenging models, are significant as native tissue has regenerated after 8 months. From a commercial perspective, as CardioCel® is a Class III medical device, it has a much more straightforward and cost effective route to market compared to biologic agents and stem cells that are targeting cardiac repair,” said Bob Atwill.
Allied is expecting to present the full data at an international scientific meeting and in peer reviewed publication in the near future.
CardioCel® has now been successfully implanted for the repair of congenital heart defects in Australia by Professor Tom Karl under the Authorised Prescriber Scheme. Other cardiothoracic surgeons are in the final processes of becoming authorised via the Authorised Prescriber Scheme. Allied expects to announce further updates on the early use of CardioCel® in patients in the near future.
For more information, please contact:
Dr Julian Chick, Chief Operating Officer Allied Healthcare Group Tel: +61 3 9620 5454
Bob Atwill, Allied Healthcare Group Executive and CEO, Regenerative Medicine Franchise
Tel: +61 448 778 880
Media:
Shevaun Cooper
Buchan Consulting
+61 3 9866 4722
scooper@buchanwe.com.au
