Trial of xenotransplantation treatment for diabetes kicks off in Argentina
Australian-New Zealand biotech Living Cell Technologies has expanded its clinical trials to a third region, kicking off a study of its DIABECELL treatment for Type 1 diabetes in Buenos Aires, Argentina.
The xenotransplantation treatment uses insulin-producing cells from pigs that are specially encapsulated and surgically implanted into the patient, allowing them to produce insulin.
Two patients with Type 1 diabetes have already been signed up, with up to six more to be added to the trial, including individuals with unstable diabetes and severe hypoglycaemia.
The patients in the trial will each receive two implants of DIABECELL three months apart, which is a different approach to that used in previous trials.
“We have a treatment that works,” said LCT medical director and acting CEO Bob Elliott. “However, during this next stage of our clinical trial we will use fewer insulin producing cells, implanted on two occasions and also utilise a different implantation technique to determine if we can provide patients with even greater benefit. The cells were produced by an improved technique that can also be more readily upscaled,” he said.
“We hope to see the effect of these even lower and repeated doses. We are looking for most effective combination before we enter into our final stages of commercialisation.”
LCT will also employ a new variation of the company’s patented IMMUPEL cell encapsulation technique. The new process avoids a source of capsule imperfection that may affect function. IMMUPEL is used to encapsulate the porcine insulin producing cells to prevent rejection by the recipient.
LCT stock (ASX:LCT) rose 5% today to 6c in afternoon trading.
DMP for diabetes type 1: guidelines indicate some need for revision
On 22 August 2011, the German Institute for Quality and Efficiency in Health Care (IQWiG) published the results of a literature search for evidence-based clinical practice guidelines on the treatment of people with diabetes mellitus type 1. The aim of the report is to identify those recommendations from current guidelines of high methodological quality that may be relevant for the planned revision of the corresponding disease management programme (DMP). According to the results of the report, there is no compelling need for revision of any part of the DMP. However, IQWiG identified various aspects that could be supplemented and specified.
Evidence was documented in detail
One of the responsibilities of IQWiG specified by law (Social Code Book V) is to develop and issue recommendations for DMPs. In the commission now completed, which was awarded by the Federal Joint Committee (G-BA), IQWiG systematically searched for new guidelines, assessed their methodological quality, and extracted relevant recommendations on the diagnosis and treatment of diabetes mellitus type 1, its accompanying diseases and late complications, as well as on the cooperation of health care sectors. In addition, the Institute documented how highly the guideline authors graded the robustness of the recommendations. However, the sources of the recommendations were not examined again; this is where IQWiG’s guideline appraisals and benefit assessments differ.
No contradictions between the DMP and current recommendations
A total of 23 German and international guidelines containing recommendations on the treatment of diabetes type 1 were included. As the analysis showed, the recommendations in the guidelines are, by and large, consistent with the specifications of the DMP. No contradictions in content concerning the DMP requirements were found. The Director of IQWiG, Professor Dr med. Jürgen Windeler, stresses that “patients with diabetes mellitus type 1 can thus be sure that the current DMP is consistent with the current status of medical knowledge on all main points.”
Some potential additional recommendations identified for the DMP
However, in these guidelines recommendations were found on a total of 8 subject areas from which, after examination and discussion, the need may arise to update and supplement the German DMP for diabetes mellitus type 1.
For example, some guidelines recommend higher blood glucose levels (increase in HbA1C) in patients susceptible to hypoglycaemia, as well as dietary advice and therapy. Neither item has so far been included in the legal regulations on the DMP for diabetes mellitus type 1. Moreover, while the DMP currently mentions only the diagnosis and treatment of diabetic retinopathy, guidelines also include recommendations on the treatment of clinically relevant macula oedema. These three aspects of treatment could in future be additionally considered in the DMP.
It is the Institute’s responsibility, first of all to identify differences between guideline recommendations and the DMP. The Federal Joint Committee then examines whether these differences should actually lead to a revision of the DMP for diabetes mellitus type 1.
Procedure of report production
IQWiG published the preliminary results in the form of the preliminary report in November 2010 and interested parties were invited to submit comments. When the comments stage ended, the preliminary report was revised and sent as a final report to the contracting agency, the Federal Joint Committee, in June 2011. The written comments are published in a separate document at the same time as the final report. The report was produced in collaboration with external experts.
Warning about effects of cabin pressure on diabetes
Scientists in Australia have issued a warning about the effects of cabin pressure on insulin dispensers. A study has shown that in-flight cabin pressure could result in insulin pumps delivering either too much or too little of medication, which could put more sensitive diabetics at risk.
The research recommended that people disconnect their pump before flying, and ensure there are no air bubbles in the insulin when they reconnect it at cruising altitude and again on landing.
The study examined ten different insulin pumps, mainly used by people suffering from type 1 diabetes to deliver insulin throughout the day, finding that during takeoff, as the air pressure decreased, the pumps were delivering around small amounts of extra insulin, while during landing, when the pressure is increasing, some insulin was going back into the pumps so that they delivered too little of the treatment.
The study, which was published in the journal Diabetes Care, said that the problems were not common but could mean diabetics receiving the wrong amounts of insulin. The suggested a range of safety checks, including insulin cartridges only containing a certain amount of insulin.
Researcher Bruce King said “I believe most people would rather know exactly how much insulin their pumps were giving. Following the recommendations means that they know and are in control of what is happening with their pump.”
