An advanced cell therapy clinical trial called “Salamander” has been launched at University Hospital of Wales to help prevent limb amputations and reduce severe pain for diabetic patients by stimulating blood vessel growth. It is a European study aiming to recruit hundreds of patients and lasting two years.
The Welsh Blood Service, along with Cardiff and Vale University Health Board are part of the consortium, running the study. (Midlands-Wales Advanced Therapy Treatment Centre (MW-ATTC, comprising Birmingham, Wales and Nottingham)
Mr Ian Williams, Consultant vascular surgeon and Principal Investigator said: “This is an exciting study to examine the effects of injecting patients own cells into the artery of the leg and see if this aids healing of ulcers which is not deemed suitable for radiological techniques or bypass surgery. This also ultimately may reduce the need for extensive wound debridement or even amputation”
Dr Mark Briggs, head of cell and gene therapy strategy at the Welsh Blood Service, explained: “The real difference here is that the patient’s own cells, sourced from their bone marrow, will be used to help revascularise their limbs and thus help reduce resting pain and hopefully prevent limb amputation. This is a new treatment and very different from all others currently on offer. It is important to note that it treats one aspect of the symptom of diabetes associated peripheral arterial disease, which causes non-healing ulcers in toes and feet and not diabetes itself.”
Diabetic patients with the condition (critical limb ischemia) are in the late stages of peripheral arterial disease and symptoms include:
- a severe burning pain in your legs and feet that continues even when you’re resting
- your skin turning pale, shiny, smooth and dry
- wounds and ulcers (open sores) on your feet and legs that don’t heal
- loss of muscle mass in your legs
- the skin on your toes or lower limbs becoming cold and numb, turning red and then black, and/or beginning to swell and produce foul-smelling pus, causing severe pain (gangrene)
Traditional treatment options focus on restoring the blood flow and opening the veins through stents, balloons, catheters or bypasses, where the surgeon makes a new connection between blood vessels in the leg around the narrowed blood vessel, to try and improve the blood flow to the calf, foot and toes.
However, for many patients with diabetic foot, it is not possible to use an endovascular (less invasive) or surgical procedures and the only remaining option is amputation of the foot.
Diabetes continues to increase in Wales (194,693 people in 2019) and it is estimated that half a million will be diabetic by 2050. Currently around 2,000 diabetics have non-healing ulcers/wounds in their feet that lead to hundreds of amputations each year.
The health consortium conducting this clinical trial is jointly led by the Welsh Blood Service (on behalf of NHS Wales) and the National Institute for Health Research Birmingham Biomedical Research Centre. It has been awarded £7.3M of UK Government funding to ensure more patients benefit from a new generation of breakthrough therapies. £1.5M will come directly to NHS Wales and £550K to Trakcel, a Welsh software company developing scheduling/tracking software for advanced therapies; based upon technology developed at Swansea University (read the press release for more information)
For more information on the “Salamander” clinical trial: