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IiME - UK RITUXIMAB TRIAL PROJECT

Progress of the B-cell Research Project

Update from UCL, London. August, 2014

 

 (Dr Jo Cambridge (Principal Investigator)  and Team, Rayne Institute, UCL, London).

 

The aim of this initial study at UCL is to establish baseline parameters in anticipation of monitoring the numbers, sub-types and functions of B-cells (a sub-population of white blood cells) during the anticipated clinical trial of rituximab.

We propose to obtain blood samples from 100 CFS/ME sufferers and 50 age-matched healthy control subjects within the next 6 months.

Thanks to the support of Invest in ME, we are very pleased to have employed Fane Mensah (pictured) as a Research Assistant within the Rheumatology Unit at UCL.

The Clinical Co-ordinator for the study at UCLH is Dr Coziana Ciurtin, Consultant Rheumatologist at UCLH who has already provided practical advice and obtained Ethical Approval for the study.

We have also been extremely fortunate to have Dr Arti Sharma (also pictured) on board who has volunteered her expert services in clinical trial administration and who is also an Immunologist, to sort out the extremely complicated logistics involved in recruiting, consenting, setting up appointments and taking blood samples plus all the considerable associated paperwork.

It is a huge task! We have also had to co-ordinate patient visits for patients recruited from 2 different Clinicians based at 2 different hospital sites.

Fane and Arti have done an amazing job and the project is now up and running.

We had a few glitches, as some of you will know, with the dedicated ansaphone not answering the phone (apparently switchboard hadn’t flipped a switch) but all working now.

We have also set up an email address where the patients can contact the Team to confirm appointments or to get advice.

All seems to be working well now, and we are running up to 3 clinics a week.

7 patients have already been studied.

Visits take about 45 minutes - patients have to fill in some questionnaires and consent forms but this also gives an opportunity for patients to ask questions about the study.

Fane’s work then begins with the blood samples.

He freezes some of the cells and serum for use in other experiments but needs to use the fresh cells in order to measure all the different sub-types (10 basic categories with up to 60 minor cell populations).

Analysis of these complicated results takes many more hours!

Our experience with rituximab treatment in patients with a number of other diseases over the last 15 years allows us to have good idea of what to look for in CFS/ME, particularly with respect to changes in certain types of B-cells which give us clues as to which ones may be involved in responding to this treatment and therefore what may underlie some of the symptoms.

We are also interested in certain molecules present in non-cellular fractions of the blood (i.e. serum), the levels of which change in relation to B cell activity.

As serum samples can be easily frozen we can perform these tests developed here at UCL on large batches of samples from other centers.

We are currently in the process of measuring these molecules in patients with CFS/ME and have already got some extremely exciting results which we look forward to publishing as soon as possible.

Briefly, it may help us identify why some patients may respond better than others to rituximab.

 

I look forward to giving you some more specific information about our progress and results soon.

 

Kind regards

 

Jo (Geraldine) Cambridge), Fane and Arti.

ukrituximabtrial.org

Further Information:

Location for the Clinical Trial - click here

 

Return to IiME - UK rituximab trial News page

 

Last Updated: August 2014  

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