Pre-clinical studies

2013

An initial pre-clinical study assessed the safety and performance of Smart Matrix® as a dermal replacement scaffold in a porcine, full-thickness wound model with the use of an overlying skin graft. It was concluded that Smart Matrix® functioned as a suitable and effective wound repair matrix. This data, along with other in vitro safety data supported an application to MHRA for approval to conduct the first clinical trial using Smart Matrix® in 2014.

2016

A further set of pre-clinical studies in a porcine model was completed in 2016. These studies aimed to:

  • Fully test the ability of Smart Matrix® to heal full thickness wounds without an overlying split thickness skin graft
  • As a control, compare how wounds healed that were left without any treatment
  • Also as a control, compare how wounds healed with just a skin graft
  • Produce the necessary data to apply to the Medicines and Healthcare products Regulatory Authority (MHRA) for permission to carry out a human clinical trial without a skin graft.

All wounds healed effectively using Smart Matrix® without a skin graft and no safety issues were observed.

Pre-clinical studies

2013

An initial pre-clinical study assessed the safety and performance of Smart Matrix® as a dermal replacement scaffold in a porcine, full-thickness wound model with the use of an overlying skin graft. It was concluded that Smart Matrix® functioned as a suitable and effective wound repair matrix. This data, along with other in vitro safety data supported an application to MHRA for approval to conduct the first clinical trial using Smart Matrix® in 2014.

2016

A further set of pre-clinical studies in a porcine model was completed in 2016. These studies aimed to:

  • Fully test the ability of Smart Matrix® to heal full thickness wounds without an overlying split thickness skin graft
  • As a control, compare how wounds healed that were left without any treatment
  • Also as a control, compare how wounds healed with just a skin graft
  • Produce the necessary data to apply to the Medicines and Healthcare products Regulatory Authority (MHRA) for permission to carry out a human clinical trial without a skin graft.

All wounds healed effectively using Smart Matrix® without a skin graft and no safety issues were observed.

Clinical trials strategy

Clinical trials strategy

Background to first clinical trial

Following MHRA approval in June 2014, Smart Matrix Ltd commenced a clinical trial in two UK hospitals with a planned group of 20 patients, comprising a safety cohort of 5 patients and a pilot cohort of 15 patients.

The primary aim of the trial was to demonstrate the safety, tolerability and performance of Smart Matrix® in combination with a skin graft to achieve wound closure.

The safety of Smart Matrix® was demonstrated to the satisfaction of the independent data monitoring committee responsible for the oversight of the trial. However, there was an unexpected and exciting outcome related to the performance of the product.

Result of first clinical trial

Four patients in the initial five-patient safety cohort experienced skin graft failures. However, it was observed that wounds healed very well despite the skin graft loss and in some cases had a better appearance than might be expected if they had been left untreated or treated with a skin graft alone.

Wounds had little contour defect and a good colour match to the surrounding skin. This suggests that Smart Matrix® was having a positive effect on wound healing even though the provision of an overlying epidermal layer (via the skin graft) was lost.

Game-changing unexpected findings

The experience from the first five patients in the study suggested that Smart Matrix® may have a more valuable and until then unexpected Unique Selling Proposition, namely the ability to close wounds without the need for a skin graft.

Treating wounds with Smart Matrix® without an overlying skin graft could have the following potential benefits:

  • Less trauma for the patient, specifically the avoidance of the pain and suffering caused by the excision of skin from a donor site
  • Reduced costs, including from the reduction in time spent in theatre
  • Improved quality of healing in terms of colour match and reduction in contour defect
  • Easier and more cost-effective management during the healing process. Both clinical groups described wounds treated with Smart Matrix® as being easy to manage during the healing process. Problems that may occur during wound healing include the formation of slough, exudate, crusting or inflammation and bleeding; none of these problems were observed in wounds treated with Smart Matrix®.

Second clinical trial

SML has now completed the transfer of its manufacturing process to a contract manufacturing organisation (“CMO”), Collagen Solutions, and the manufacture of the Smart Matrix® clinical and stability batches for use in the clinical trial has been successfully completed.

Having now received both MHRA (The Medicines and Healthcare Products Regulatory Agency) and Ethics (The Research Ethics Service of the NHS) approval in the UK, is currently preparing a second clinical trial to assess the safety, tolerability and performance of Smart Matrix® when used without a skin graft. The clinical trial will commence in Q3 2018.

Testimonials

“When I first saw the final results of wound healing from Smart Matrix® I was really quite excited. I felt it exceeded what I was able to achieve with a skin graft and other standard methods.”

Dr Fulvio Urso-Baiarda

Consultant Plastic Surgeon

“They have all healed!! This is of course not always achievable even with a skin graft.….”

Mr Norbert Kang

Consultant Plastic Surgeon, UK