BIOTECH firm Tissue Regenix said a two-year study has proved its regenerative patch for blood vessels is “safe and effective”.
The York-based firm, which grows replacement body parts, said the study found the dCELL patch to be useful in repairing veins.
The study, which began in August 2009, involved 21 patients with a history of vascular disease. They required surgery to remove a blood vessel blockage in order to restore blood flow and reduce the risk of possible amputation.
The group of patients was suffering from a number of severe and debilitating illnesses such as diabetes.
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.
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.
The technology was developed from research by Professors Eileen Ingham and John Fisher at the University of Leeds.
Tissue Regenix believes the dCELL process has other medical applications, including in heart valve replacement and knee repair.
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.”
Four patients died during the study – although their deaths were unrelated to the patch.