A TWO-year study has proved the safety and effectiveness of a regenerative vein patch, according to biotech firm Tissue Regenix.
The York-based firm, which grows replacement body parts, said the study found the dCELL patch to be useful in repairing blood vessels.
The study, which began in August 2009, involved 21 patients with a history of vascular disease and required surgery to remove a blocked blood vessel. The group of patients was suffering from a number of severe and debilitating illnesses such as diabetes.
David Russell, consultant vascular surgeon at Leeds General Infirmary, said: “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.”
The dCELL patch is made from pig tissue which has been decellularised or stripped of its DNA, to create a scaffold for new growth.
After 12 and 24 months, scans of the patched veins struggled to spot the patch, which Tissue Regenix said suggested it had been integrated into the patients’ own veins.
Alan Dardik, associate professor of surgery at Yale University, has conducted his own pre-clinical studies using the Tissue Regenix dCELL vascular patch.
He 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.”