ATTeST trial to restart recruitment
We are delighted to announce that the hold on recruiting people onto the ATTeST trial of the EryDex system, which had been due to start at Nottingham in January, has now been lifted.
Recruitment of new participants to the trial was halted in January by the US Food and Drug Agency, although patients already enrolled were permitted to continue treatment.
The reason for this was that some samples taken prior to infusion into patients were found on testing to be contaminated by bacteria. To be clear, it was only samples for testing that were involved, and only a few of these.
It has now been concluded that the contaminations that led to the partial hold were not ‘true’ contaminations of the blood product that is re-infused into the patient. Rather, they were the result of external handling of the samples taken for testing. Additionally, full implementation of aseptic measures to minimise the risk of future contaminations has now been completed at all sites.
The hold has been in place for nearly 10 months so there will be a number of procedures to go through before screening of new potential participants can take place. This will vary from centre to centre and may take from a few weeks to a couple of months.
The A-T Centre in Nottingham hopes to be able to start screening again by the end of November, but as the decision has only just been announced, it is unable to be more specific for now. We will update this information as and when we can.
The A-T Society’s chief executive William Davis said: “It needs no saying that the safety of participants in the trial must be our number one priority. However, this long delay to the trial has been very stressful for families who hoped to be involved. We are very happy that it can now restart. We will give all the help we can to help make sure that it is carried out as quickly and effectively as possible, so that we can discover whether the treatment is truly effective. ”
If you have any further questions about the trial, please contact the A-T Society on 01582 760733 or email firstname.lastname@example.org.