Open Norway: Plasma cell aimed treatment with daratumumab in ME/CFS (ResetME) - Haukeland University Hospital

The recent news article has now been published in another paper without a paywall.

TL;DR about the study:
  • Only need 5.5M NOK ($550k) to fully fund the study.
  • 300 have asked to participate so far (need 66).
Initially, I and others have believed that the study didn’t have any additional funding when they announced the 4M NOK contribution from the ME-fund a few months ago. That was not the case. At that point, they only needed an additional 8M NOK out of a total of 26M NOK.

The 8M NOK have never been communicated widely publicly before, but has recently been confirmed in an (essentially public) fb group by multiple people that should be in the know.

www.nettavisen.no

Vilde ble ufør som 25-åring

Nå er Vilde (33) med i ny ME-studie på Haukeland. – Det gir meg håp.
www.nettavisen.no www.nettavisen.no
 
hotblack said:
Thanks for the update @Utsikt It’s a shame they weren’t clearer over the funding, but who knows what uncertainties there have been behind the scenes and well, it’s fantastic they look likely to get all that is needed.
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Based on the responses by the people in the know, this is probably just a case of unclear communication and misinterpretations by me and other readers. It sounds like the 18M NOK have been secure since the start of the study.

This makes sense because they said that they would get it done eventually regardless of the future funding, and that implies that they could at least afford the drugs.
 
The new name is out: ResetME

Auto-translated:
The "ResetME" study is underway, and we are pleased to report that there is a great deal of interest in participating in the study. We have received significantly more applications than there are places in the study, and we have begun the extensive work of selecting participants.

The inclusion process will take place continuously throughout the fall, winter and spring, and we will review and assess all applications we have received. The first patients have already been included in the study, and we will provide the first treatment at the end of September.

Candidates who, based on the initial assessment, appear to be suitable for the study will be contacted directly and invited to an informational interview. If they agree to participate in the study, a clinical assessment will then be carried out with a questionnaire, blood tests, a doctor's interview and physical tests. Only when all results are available can our doctors decide whether the candidate can be included in the study.

This process is time-consuming and is carried out in parallel with included candidates starting registration, processing and follow-up in the study. It will therefore take time before we provide feedback to everyone who has sent us an application to participate.

If it is considered that you are not a suitable candidate, you will be informed of this, but we hope for your understanding that we do not have the capacity to provide detailed individual feedback to everyone.
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www.helse-bergen.no

Stor pågang til ny studie

"ResetME"- studien er i gang og det er stor interesse for deltagelse. Inklusjonsprosessen vil foregå fortløpende gjennom høsten.
www.helse-bergen.no www.helse-bergen.no

PS. Maybe we should update the title and add a tag to make it more sesrchable?
 
Utsikt said:
The new name is out: ResetME

Auto-translated:

www.helse-bergen.no

Stor pågang til ny studie

"ResetME"- studien er i gang og det er stor interesse for deltagelse. Inklusjonsprosessen vil foregå fortløpende gjennom høsten.
www.helse-bergen.no www.helse-bergen.no

PS. Maybe we should update the title and add a tag to make it more sesrchable?
Click to expand...
Thanks, updated title.

I assumed it was going to be DaraME to follow the theme of CycloME and RituxME.
 
By the way,

I realized if they screen 300 patients, and had 300 patients do blood NK cells, and maybe fill up an SF36 or some questionnaire, then you have a very valuable and relatively large dataset of NK cell vs severity in ME patients and we can see the count distribution in ME patients.

Is this something they would have done? If so, is there any way to contact them to ask them to release the data? @Jonathan Edwards is this something feasible that a researcher could do?

I don't believe there has been any study that took that many NK cells of ME patients. it would be very valuable data.

However I have no idea what the recruitment procedure is like and if they would take the NK cells of every applicant.

Would be good to have perspective of someone who has ran trials before.
 
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There are logistical reasons that makes it likely that they will only do blood samples if you tick every other inclusion criteria first.

If we are lucky, they will do the assessment of the ME/CFS diagnosis in person and do the blood draws at the same time, but for accessibility reasons I would personally design it so that any interview is done first digitally or over phone to spare the patients an unnecessary trip, and to save resources.

They have published papers on blood samples collected from their previous studies, so they might want to do the same for NK cells. In that case, we will probably have to wait for them to write the paper because they might want their publication points (I blame the system).
 
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