dCELL(R) vascular patch is safe and effective

RNS Number : 6915L

Tissue Regenix Group PLC

07 September 2012

 

Date: 07 September 2012

Tissue Regenix pioneering dCELL® vascular patch shown to be safe and effective

Results from two year clinical study demonstrate a strong safety profile and s as well as long term durability

The two year clinical study to evaluate the safety and performance of Tissue Regenix Group plc's ('Tissue Regenix') dCELL® vascular patch supports the conclusion that it is a safe and effective device when used in vascular surgery.

The study, which began in August 2009, involved 21 patients who all had a history of prior peripheral vascular disease and required surgery to remove a blood vessel blockage to restore blood flow and reduce the likelihood of further complications including possible amputation. The group of patients was typical of those with peripheral vascular disease and were suffering from a number of severe and debilitating illnesses such as diabetes.

The 24 month follow up was consistent with the findings of the 12 month follow up, with post-surgery scans of the patched veins showing that it was difficult or impossible to visualise the Tissue Regenix dCELL® vascular patch, which suggested it had been integrated into the patients' own vein.

Mr David Russell, Consultant Vascular Surgeon, Leeds General Infirmary commented: "The two year results for the Tissue Regenix dCELL® vascular patch demonstrate it to be a safe and effective alternative for routine vascular use. Even though the trial was relatively small the results show the patch has an excellent safety profile and the most encouraging results are the sonographic findings indicating incorporation of the patch into the patients' own veins and no evidence of patch expansion. These suggest that this patch will be durable with excellent patency rates."

Alan Dardik, Associate Professor of Surgery at Yale University, who has conducted his own pre-clinical studies using the Tissue Regenix dCELL® vascular patch said: "The results and conclusions of this report show several important points. First, the dCELL patches continue to show an outstanding safety profile that suggests their safety in general practice. Secondly the lack of significant neointimal hyperplasia in the patches, in face of progressive patient disease, suggests the potential for dCELL patches to maintain long term patency, and therefore the potential for long-term superiority compared to other currently available products. As such, dCELL patches appear safe and effective within the first 24 months of implantation."

Antony Odell, Managing Director of Tissue Regenix said: "Regenerative medicine is increasingly becoming a focus for the healthcare industry and stem cell companies are spending millions of pounds developing ways of handling and delivering stem cell treatments to patients.  However, our patented technology shows that we can deliver treatments effectively but much more efficiently and potentially at a significantly lower cost."

Tissue Regenix is developing further applications of its dCELL® technology platform, for example, by progressing a dialysis graft for patients with kidney disease into the clinic, which, it is hoped, will mitigate some of the associated risks and reduce the cost of expensive dialysis

-ENDS-

Notes to Editors:

All patients in the trial underwent a standard surgical procedure (elective peripheral endarterectomy, including the removal of the atherosclerotic plaque, suturing of any loose intimal elements and close with a Tissue Regenix dCELL® vascular patch).

At the time of the 24 month follow-up assessment clinical and sonography data was only available for 15 of the 21 cases in the study. Previously at the 12 month postoperative assessment data had been available for 18 of the 21 cases and at 6 month postoperative assessment, clinical data collected for all 21 patients who received the dCELL® patch and sonography data was available for 19 patients.

There were a number of adverse events in line with what would have been expected from this group of patients, although in every case it was concluded that the Tissue Regenix dCELL® vascular patch, and the procedure, were either not related to the event, or were unlikely to be related to the event. A total of 4 patients died during the course of the study. In all cases there were no reported problems with the patch in situ at the time of their last clinic visit.

For Further Information

Tissue Regenix Group plc:                                                           01904 435 176

Antony Odell

Ian Jefferson

Peel Hunt LLP (Nominated Adviser)                                        020 7418 8900

James Steel

Vijay Barathan

Newgate Communications                                                          020 7680 6550

Alistair Kellie

Andrew Adie

Martin Greig

About Tissue Regenix

Tissue Regenix, (AIM:TRX) the regenerative medical devices company , was incorporated in May 2006 to commercialise the academic research of Professor Eileen Ingham and Professor John Fisher from the University of Leeds in the field of tissue decellularisation.

The dCELL® Vascular Patch provides a highly biocompatible patch for peripheral vascular reconstruction that supports infiltration of the patient's own cells allowing host tissue regeneration.

The dCELL® Vascular Patch is manufactured from porcine pericardium using the proprietary dCELL® process. The dCELL® process removes cellular material from tissues while maintaining the structural and biomechanical properties. This results in an acellular, immunocompatible and immediately functional material.

The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

Alan Dardik, M.D., Ph.D., F.A.C.S.
Dr. Alan Dardik is Assistant Professor of Vascular Surgery at Yale University School of Medicine. In addition, Dr. Dardik is Director of the Non-invasive Vascular Laboratory and the Director of Surgical Research at the VA Connecticut Healthcare System.

Dr. Dardik received a Bachelor of Science degree and graduated summa cum laude from Yale University. He received his Doctor of Medicine and Doctor of Philosophy degrees from the University of Pennsylvania School of Medicine. He completed his surgical residency, his research fellowship and his vascular surgery fellowship at The Johns Hopkins Hospital, Baltimore, Maryland. Dr. Dardik has received the Franklin Martin Faculty Research Fellowship from the American College of Surgeons, the E.J. Wylie Traveling Fellowship from the Lifeline Foundation, and was named the Wylie Scholar in Academic Vascular Surgery by the Pacific Vascular Research Foundation. He has also received the William J. von Liebig Vascular Academic Award from the Peripheral Vascular Surgery Society.

 

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