bioMD Limited ABN: 35 088 221 078
Copyright Disclaimer Privacy Policy
Corporate Governance
Celxcel 
A Tissue Engineering Company
 

 

PHASE II CLINICAL TRIAL

A Phase II Human Clinical Trial commenced in April 2008 with the first implant of the ADAPT® "CardioCel" bovine pericardial patch bioimplant.

The primary objectives of this trial are to evaluate the safety, efficacy and clinical performance of the CardioCel patch in cardiovascular surgical repair procedures. Secondary endpoints are the evaluation of its design features, such as handling characteristics, shape and sizing requirements, as well as implant procedures.

The CardioCel patches are to be implanted into 50 patients requiring bioprosthetic tissue substitution to support repair of atrial and ventricular septal defects, aortic root enlargements and outflow tract reconstructions.

The trial is being conducted by Professor Francis Smit, head of the Department of Cardiothoracic Surgery at the Universitas Hospital in Bloemfontein, South Africa.

The trial is being conducted in South Africa where there is a high incidence of congenital heart disease that causes heart deformities.

This is a key milestone in establishing the safety and efficacy of the ADAPT TEP CardioCel patches in humans.

Each patient will have a post-operative follow-up period of 12 months. Follow-up procedures include echocardiographic examinations at 6 and 12 months. Each echocardiographic examination will include haemo compatibility, calcification status and the general efficacy and stability of the implant patch. Selected patients will undergo magnetic resonance imaging (MRI) as part of their follow-up assessment.

ADAPT®

TISSUE ENGINEERING PROCESS

The ADAPT Tissue Engineering Process (TEP) is a new platform technology developed by Celxcel Pty Ltd, a subsidiary company of bioMD Limited. ADAPT TEP was developed over many years by Celxcel's Chief Scientific Officer, Professor Leon Neethling.

ADAPT TEP is used for processing animal derived tissues to produce implantable biologic soft tissue repair materials that are biocompatible with the human body. These bioimplants are used in the reconstruction and regeneration of malfunctioning human tissue such as heart valves, hernias, pelvic floor muscle structures and orthopaedic soft tissues.

ADAPT TEP has been proved to significantly reduce calcification levels and to improve durability and functionality of implanted soft tissue repair products. Additionally, the process significantly improves the ability of the bioimplant to regenerate and remodel to that of its surrounding human soft tissue. ADAPT TEP allows site specific controlled remodelling where the bioimplant replicates the characteristics of the surrounding human tissue. These factors combine to signficantly improve the overall performance of the bioimplant.

Numerous pre-clinical studies confirm that ADAPT TEP works equally well with bovine, porcine and kangaroo derived tissues.

Continuing Research

The Company is continuing to evalute the ADAPT Tissue Engineering Process for use in surgical applications such as general surgery (heria repair), urogynaecology (pelvic floor reconstruction), orthopaedics and cardiovascular repair.

 

 

 

For more information on the

ADAPT Tissue Engineering Process

click here