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Dr Jo Cambridge update on UK Rituximab trial

Sasha

Fine, thank you
Messages
17,863
Location
UK
This doesn't seem to have been posted yet:

http://www.ukrituximabtrial.org/Rituximab news-Aug14 02.htm

and it's looking exciting:

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.​

@Jonathan Edwards - I've been wondering whether, if a UK biobank had already been set up, whether you'd have been able to use it to do this work immediately. If I understood your comments some months back, it was having to get ethical approval and recruit well-defined patients that was causing the delay.

The MEA are currently raising money for the UK biobank - big fundraising push with big matching funds possible.

There's a chance to meet the scientific team involved with the biobank in a week's time in London.
 

Jonathan Edwards

"Gibberish"
Messages
5,256
@Jonathan Edwards - I've been wondering whether, if a UK biobank had already been set up, whether you'd have been able to use it to do this work immediately. If I understood your comments some months back, it was having to get ethical approval and recruit well-defined patients that was causing the delay.

The MEA are currently raising money for the UK biobank - big fundraising push with big matching funds possible.

There's a chance to meet the scientific team involved with the biobank in a week's time in London.

We have had the usual delays in committees but these are dealt with at least for the work in progress. We need to be absolutely sure we know that we are studying standardised cohorts with standard referral origins. This may sound over-cautious but it may be that people who go to neurologists have a different disease from those that go to rheumatologists or immunologists. So UCL are studying two groups of patients locally and are also studying a group from an international collaboration, extremely well documented. I cannot give details of what Jo Cambridge is referring to but she has been looking at levels of signalling molecules in a very well defined context. I saw them for the first time last week and they are very encouraging. Apart from anything else they make me absolutely sure that we have done the right thing to get these preliminary studies under way before we start a trial.

The Biobank may be very useful. I have met the researchers involved at the IiME Colloquium. They have samples but the referral sources are not as yet clearly enough defined for us to use these for the studies we are doing now. They may be useful for confirmatory studies. Hopefully everyone can benefit from each other's expertise on this.
 

Simon

Senior Member
Messages
3,789
Location
Monmouth, UK
I think this looks very interesting, and thought I would pick out some key points:
  • 100 patients + 50 controls in next 6 months
This is impressively big, and I think larger than originally planned for the initial study.
  • 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 during the anticipated clinical trial of rituximab.
  • They will use fresh cells in order to measure all the different sub-types [of B-cells] (10 basic categories with up to 60 minor cell populations). [my guess is by flow cytometry, which sorts/counts cells by surface marker molecules, but I'm not certain they're doing this]
  • 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 serum, which change in relation to B cell activity. 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.
========================
So, they seem to have early results (from another study) based on serum assays too, separate from the work on identifying B-cells directly. So my guess is flow cytometry to detect B-cell subtypes, plus serum assays for additional info => sub-groups they expect will respond differently to Rituximab.

I cannot give details of what Jo Cambridge is referring to but she has been looking at levels of signalling molecules in a very well defined context. I saw them for the first time last week and they are very encouraging. Apart from anything else they make me absolutely sure that we have done the right thing to get these preliminary studies under way before we start a trial.
Intrigued!
 
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Aidan Walsh

Senior Member
Messages
373
There is a so far unsubstantiated claim that our NK cells are fine in isolation but inactivated in serum. If we are now measuring known factors in serum that directly impact B cell function, systematically, then it may yield insights that are extremely useful, even if most of it is only about ruling out possibilities.
No worries Phyciatry is not a Science 'psychosomatic' does not even exist it is all one big fraud from day one...The whole concept of Phyciatry is actually based on fraud...They invented Quackery the majority of Doctors who enter this field are seeking help for themselves...
 

beaker

ME/cfs 1986
Messages
773
Location
USA
Wondering if, in consideration of information from Lipkin,Horning, et al... if there will be any consideration to having some patients in the less than 3 year time. I know @Jonathan Edwards has said in the past that it's important not to have too many questions in a study and also that Lipkin hasn't been confirmed yet by other studies.... BUT still would be interesting to take note if response was different.
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
Just wondering if you're able to say anything about how this is all progressing, @Jonathan Edwards - maybe even just some indication of timescale?

I realise it's important that this thing is done right rather than done quickly, of course, as I'm sure we all do.
 

Sasha

Fine, thank you
Messages
17,863
Location
UK
I was just looking at IiME's site to see if they'd got any updates and came across this (scroll down a bit):

http://www.investinme.org/IiME Current Research Studies.htm

Invest in ME said:
Autoimmunity and ME

HYPOTHALAMUS
Invest in ME are working with researchers, as part of the examinations facility proposal and to support the rituximab trial, on a more comprehensive and detailed analysis of antibodies binding the hypothalamus.

This is important as these are more likely to explain various ME symptoms.

This, along with a search for anti-cytokine antibodies, will form the first the part of work on autoimmunity in ME.

This project will take between 15 and 18 months with a further 3 months for data analysis and publication.

The funding of this research is via the Invest in ME Biomedical Research Fund.

@Jonathan Edwards, is this to do with the work that Jo Cambridge gave the update on (in the first post on this thread)? Or something new entirely? Is it to do with the preparation for the rtx trial ?

There's no date on it - do you know when it started?
 
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