Research into a new treatment for nerve damage caused bydiabetes could bring relief to millions of diabetic patients, sayexperts.
The treatment might also reduce the number ofamputations of toes and feet if early effects on nerve protection andregeneration are borne out long-term. Nerve disease in diabetes is themajor cause of non-traumatic lower limb amputations in Europe and NorthAmerica.
Scientists at The University of Manchester, working withcolleagues at American biotech firm Sangamo BioSciences Inc, havediscovered a way of stimulating genes that prevent nerve damage causedby the disease.
Professor David Tomlinson, who is leading theresearch in Manchester, says the study has massive potential for themanagement of diabetic neuropathies or nerve disorders.
"Diabeticneuropathy is a major problem in insulin-dependent diabetes,particularly in patients who have had the disease for a period oftime," said Professor Tomlinson, who is based in the University'sFaculty of Life Sciences.
"This approach to gene therapy is quitedifferent to previous attempts at treatment as we do not inject a genethat produces a 'foreign' copy of a therapeutic protein. This is thenormal approach and has problems from immunological side-effects.
"Instead,we turn on the patient's own gene to produce a natural version of thistherapeutically beneficial protein. The most significant advantage ofthis is that the protein is made as if the patient's body had made itnaturally.
"Our study has shown that a single treatment with aDNA-binding protein protected against nerve damage that in humans canlead to limb loss."
The results of the pre-clinical studies wererecently presented to the American Diabetes Association in Californiaand the first phase of clinical trials has now begun.
Anestimated 50 per cent of patients with long-term diabetes develop someform of neuropathy that can cause numbness and sometimes pain andweakness in the hands, arms, feet and legs.
Currently, patientsare treated with painkillers and antidepressants that do not treat theunderlying nerve damage. Progression to amputation is not inevitablebut is always a threat.
Problems may also occur in other organs, including the heart, kidneys, sex organs, eyes and digestive tract.
Theincidence of diabetes, a condition in which the amount of glucose inthe blood is too high, is increasing dramatically, with the WorldHealth Organisation estimating that some 300 million people worldwidecould be affected by 2025.
The causes of diabetic neuropathy arenot fully understood but researchers investigating the effect ofglucose on nerves believe it is likely to be a combination of factors.
Sangamo'sChief Medical Officer, Dr Dale Ando, said: "We have been greatlyencouraged by Professor Tomlinson's data and have moved the programmeinto the clinic.
"The first phase of human trials will assesssafety and examine the effects of a single treatment in one legcompared with a placebo treatment in the other leg."
The Diabetes and Glandular Disease Clinic in San Antonio, Texas, is involved in the clinical trials.
DrMark Kipnes, a clinical investigator for Sangamo and endocrinologist atthe clinic, said: "Currently, there are no effective therapiesavailable to treat this debilitating and frequent complication ofdiabetes and patients are generally prescribed painkillers to alleviatesymptoms.
"We are excited to be involved in testing this novelapproach that may potentially have a dramatic therapeutic effect inpopulations of patients already suffering from neuropathy and thosethat are at risk of developing it."
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