Experts say a new treatment for nerve damage caused by diabetes could bring relief to millions of diabetic patients. Research shows that the treatment could reduce the number of amputations of toes and feet if early effects on nerve protection and regeneration are borne out long-term. One of the major causes of non-traumatic lower limb amputations in Europe and North America is diabetic nerve disease.
A team of scientists at Manchester University are working with colleagues at Sangamo BioSciences Inc an American biotech firm. They have discovered a way of stimulating genes that prevent nerve damage caused by the disease.
Professor David Tomlinso, who is heading the UK research team in Manchester, says the study has a huge potential for the managing diabetic neuropathies or nerve disorders.
“Diabetic neuropathy is a major problem in insulin-dependent diabetes, particularly in patients who have had the disease for a period of time,” said Professor Tomlinso, who is based in the University’s Faculty of Life Sciences.
“This approach to gene therapy is quite different to previous attempts at treatment as we do not inject a gene that produces a ‘foreign’ copy of a therapeutic protein. This is the normal approach and has problems from immunological side effects.
“Instead, we turn on the patient’s own gene to produce a natural version of this therapeutically beneficial protein. The most significant advantage of this is that the protein is made as if the patient’s body had made it naturally.
“Our study has shown that a single treatment with a DNA-binding protein protected against nerve damage that in humans can lead to limb loss.”
Pre-clinical study results were recently presented to the American Diabetes Association in California. Phase one of the clinical trials has now begun.
It is estimated that 50 per cent of long-term diabetes patients will develop a form of neuropathy that will cause numbness and sometimes pain and weakness in the hands, arms, feet and legs.
At present treatment is with the use of painkillers and antidepressants. As this does not treat the underlying nerve damage, progression to amputation is always a threat.
Other organs can also be affected, such as the heart, kidneys, sex organs, eyes and digestive tract.
Diabetes is a condition where the amount of blood glucose is too high. It is a disease that is increasing dramatically and the World Health Organisation is estimating that 300 million people worldwide could be affected by 2025.
The cause of diabetic neuropathy is not completely understood. Researchers looking into the effect of glucose on nerves believe it is a combination of factors.
Dr Dale Ando, Sangamo’s Chief Medical Officer, said: “We have been greatly encouraged by Professor Tomlinson’s data and have moved the programme into the clinic.
“The first phase of human trials will assess safety and examine the effects of a single treatment in one leg compared with a placebo treatment in the other leg.”
The clinical trials are being conducted at The Diabetes and Glandular Disease Clinic in San Antonio, Texas. Dr Mark Kipnes, a clinical investigator for Sangamo and endocrinologist at the clinic, said: “Currently, there are no effective therapies available to treat this debilitating and frequent complication of diabetes and patients are generally prescribed painkillers to alleviate symptoms.
“We are excited to be involved in testing this novel approach that may potentially have a dramatic therapeutic effect in populations of patients already suffering from neuropathy and those that are at risk of developing it.”
Manchester University is the largest university in the UK with 9,000 staff and 28,802 full-time students. For further information visit the University’s website at https://www.manchester.ac.uk

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