Regenerative medicine to treat leg ulcers

Regenerative medicine company Avita Medical (ASX:AVH) has reported positive results from its multicentre clinical trial of ReGenerCell in the treatment of chronic venous leg ulcers (VLUs). The randomised study saw ReGenerCell demonstrate statistically significant improvements in key measures of wound healing, pain and quality of life.

The study compared the addition of Regenerative Epithelial Suspension (RES) — which comprises the cells and wound healing factors necessary to regenerate healthy skin and is produced using the company’s ReGenerCell medical device — to conventional medical therapy alone in 52 adult patients with VLUs. The study data show 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 the control group.

In addition, patients in the ReGenerCell group reported significant drops of nearly two points on a 10-point pain rating scale two weeks after treatment, while the control group showed no decrease in pain after two weeks. As a quality-of-life measure, the Charing Cross Venous Leg Ulcer Questionnaire showed consistent improvements in the evaluated areas of social interaction, domestic activity, emotional status and cosmesis.

Other study measures showed positive trends. The incidence of complete wound closure was 26.9% in the ReGenerCell group versus 15.4% in the control group. Larger ulcers showed a closure incidence of more than triple in the ReGenerCell group, which achieved complete closure in 23.1% of patients versus 7.1% in the control group. Larger ulcers also appeared to heal in nearly half the time, with first closure happening in a mean time of 43 days with ReGenerCell versus 84 days in the control group.

The company said the pilot trial has succeeded in delivering data on appropriate treatment directions and it now plans to incorporate these results into discussions with regulatory authorities in the US and Australia to determine next steps for ReGenerCell.

The news comes two days after Avita received approval from the US FDA for a second expansion of its Compassionate Use Investigational Device Exemption (IDE) program for ReCell — technology that enables a clinician to create RES at point of care in approximately 30 min using a small sample of the patient’s skin.

The IDE supplement allows Avita to increase the total number of patients allowed for clinical evaluation of ReCell by 50%, bringing the total number of patients from 24 to 36 patients who have insufficient healthy skin available for standard skin grafting of their injury. The IDE allows the application of ReCell beyond burns and to larger, more serious defects. Investigational use of ReCell may be granted in cases where the patient’s treating physician believes that there is no suitable alternative treatment.

Avita (ASX:AVH) shares were trading 2% lower at $0.098 as of Wednesday at 3 pm.

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