A “regenerative” device for treating chronic venous leg ulcers has proved significantly better than usual care in a trial, according to researchers.
Avita Medical said its ReGenerCell product demonstrated statistically significant improvements in key measures of wound healing, pain and quality of life. It also showed positive trends both in healing time and incidence of closure, particularly in large ulcers.
“Chronic venous leg ulcers have a huge impact on patient’s quality of life”
The trial compared the addition of the company’s Regenerative Epithelial Suspension, produced using its ReGenerCell device, to conventional therapy alone in 52 patients with venous leg ulcers evaluated at six centres in the UK and one in France.
The trial data showed significant decreases in wound size from the time of treatment to the end of the 14-week study, with wounds in the ReGenerCell group closing an average of 9.1 cm2, versus 1.2 cm2 for controls.
Avita said the results indicated that the cellular suspension delivered by ReGenerCell showed “great promise as an effective treatment for healing chronic wounds that have resisted other approaches”.
In addition to significant decreases in wound size, patients in the intervention group reported significant drops of nearly 2 points on a 10-point pain rating scale two weeks after treatment.
They also showed consistent improvements in quality of life, as measured using the Charing Cross Venous Leg Ulcer Questionnaire, across social interaction, domestic activity and emotional status.
There was no difference in the adverse event rate observed in the ReGenerCell and control groups, and all adverse events experienced were consistent with those seen in similar patient populations.
While not achieving statistical significance, other study measures showed “positive trends”, said the company.
The incidence of complete wound closure was 26.9% in the intervention group, versus 15.4% in the control group. Larger ulcers (>10 to ≤80 cm2) showed a closure incidence of more than triple with ReGenerCell.
Larger ulcers also appeared to heal in nearly half the time, with first closure of large ulcers happening in a mean time of 43 days with the intervention, versus 84 days in controls.
Promising trial results for venous leg ulcer treatment
Mr Paul Hayes, lead principal investigator and consultant vascular surgeon at Addenbrookes Hospital in Cambridge, said: “Chronic venous leg ulcers have a huge impact on patient’s quality of life, as well as the economic burden to health services.
“I’m delighted that ReGenercell has shown a significant benefit for our patients in terms of quality of life and ulcer healing,” said Mr Hayes, who will present further analysis of the data next month at the Charing Cross International Symposium in London.
The company said it now planned to discuss the results with regulatory authorities to determine next steps for ReGenerCell in pursuing an indication for treatment of venous leg ulcers.
In the UK, 1.65% of the population aged over 65 have venous leg ulcer, costing the NHS more than £1bn per year – chiefly in ongoing home visits for dressing changes of treatment-resistant ulcers.