Closed Sweden 2022: The REDBANK Study - Amelieklinikin (was RED Clinic) Jonas Axelsson

mango · Sep 26, 2020

MD Jonas Axelsson, RED Clinic in Stockholm, Sweden
in collaboration with researchers at Karolinska Institutet and Lund University in Sweden, and Stony Brook University in the US.

The purpose of the REDBANK Study is to collect information on any long-term symptom grouping that appears following an infection, but that differs in character from what is usually associated with infection or its complications. By broadly collecting information and biological samples, they hope to see patterns that can be used for both diagnosis and treatments.

RED Clinic website said:

The REDBANK Study

Neurometabolic diagnoses such as fibromyalgia, ME/CFS, POTS and chronic Lyme disease were first described a long time ago, yet there is currently no adequate diagnostic test or effective treatment. Indeed, many physicians do not acknowledge these diagnoses at all!

As part of our ongoing research, RED Clinic wishes to test the often repeated hypothesis that chronic viral infections directly or indirectly can cause late-onset and long-lasting manifestations following infections with an often unknown pathogen.

These symptoms are myriad but some common ones include chronic fatigue, fluctuating skin temperature, myasthenia (such as difficulties in walking or raising one's arms above the head), insomnia, headaches, brain fog, tingling sensations, palpitations (rapid heart rythm) and dizziness.

The RED Clinic specializes in treating such syndromes, which we call these neurometabolic disease for want of a better name. With our own research laboratory we also conduct basic and clinical research aimed at identifying relevant pathogenic pathways and elucidating possible treatent options.

The purpose of this page is to recruit study subjects to our broadest and longest-running cohort - REDBANK.

How to participate
The study seeks patients with any type of infection 2-6 weeks prior to the sudden debut of unusual but long-lasting and debilitating symptoms. If you have had a positive PCR-test for SARS-CoV-2 are experiencing such symptoms, please consider instead enrolling in our other cohort study - the Scandinavian Post-CoVID Cohort (SPCC).

The purpose of the REDBANK Study is to collect information on any long-term symptom grouping that appears following an infection, but that differs in character from what is usually associated with infection or its' complications. By broadly collecting information and biological samples, we hope to see patterns that can be used for both diagnosis and treatments.

If you fulfill the criteria above, please help us by participating in the study. You do this by:

1. Giving informed consent by signing and submitting the linked consent form (eng / sv).

2. Answering the detailed 20+ pages study questionnaire (eng / sv) and submitting it together with a signed consent form as detailed below.

3. Scanning and e-mailing the resulting PDF-documents to us at info@redclinic.se - or sending the originals by regular post to us at RED Clinic AB, REDBANK Study, Vällingby läkarhus, Hus B plan 1, 162 68 Vällingby, SWEDEN.

4. Waiting for us to send you an envelope with a study kit comprising a blood sampling tube, a mouth swab and specimen jars along with a referral document that lets you leave blood at a local sampling center.

5. Making sure to collect and leave specimens according to the instructions in the envelope and - especially important - submitting these as instructed within 8 hours of collection if shipping by regular post to us using the pre-adressed padded envelope included.

There is no cost for paticipating. If you are interested in your results, please indicate that we may contact you on the consent form. Your results will then be mailed to you when they become available (which may take a long time and is dependent on our ability to secure research funding).
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https://redclinic.se/redbank.html

Kalliope · Sep 26, 2020

Is this for Swedes only, or can people living in other countries participate?

mango · Sep 26, 2020

Kalliope said: ↑

Is this for Swedes only, or can people living in other countries participate?
Click to expand...

I don't know. I couldn't find any info about that in the documents attached to/linked from the study information page.

Kalliope · Sep 26, 2020

I'll send them an email and ask

Kalliope · Sep 28, 2020

Red Clinic replied today and said the study is for people living in Sweden only, due to it involving collecting specimens.

Kalliope · Nov 1, 2020

Red Clinic was discussed today in the thread Possibility of ME or PVFS after COVID-19, Long Covid
The clinic made an appearance in a Swedish documentary about Long Covid because ME and Long Covid have similar symptoms and Red Clinic was enrolling patients for a research project on finding "remaining virus" in Covid-19 patients. The work has been put on a temporary hold, to secure ethical approval of the project.

I had a look at their webpage today and it seems they don't have any active research projects at time being.

Their webpage has both a Swedish version and an English version. If I remember correctly, only the Swedish version had a closer presentation of their approach to ME and theories of what ME is. Now this is available in English as well for those who'd like to read.

Although many diseases may be considered to involve metabolism and the nervous system, we use the term "neurometabolic disease" to refer to one of a few specific groupings of symptoms and biochemical abnormalities. Other names used to refer to similar groupings - or to subgroups of them - include myalgic encephalopathy/chrnoic fatigue syndrome (ME/CFS), postural orthostatic tachycardia syndrome (POTS), dysautonomic disease, small fiber neuropathy, fibromyalgia, Ehler's-Danlos' syndrome (EDS), chronic Lyme disease, chronic borreliosis, soldier's heart, and many more. Not everyone with these diagnoses have neurometabolic disease, but currently so few of them have been tested for it that it is hard to estimate how many that do.

More at
https://redclinic.se/eng/red.html

mango · Nov 2, 2020

redclinic.se said:

The REDBANK Study - Update October 25th 2020
[...]Unfortunately, it has come to our attention that the REDBANK study still lacks a valid ethical permit according to Lag (2003:460) om etikprövning av forskning som avser människor. The study is therefore temporarily paused in expectation of such a permit. More information when we have it.
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https://redclinic.se/redbank.html

mango · Mar 17, 2021

RED Clinic has changed names, and is now Ameliekliniken.

https://www.ameliekliniken.se/

It looks like they have removed all info about this study from their website.

mango · May 2, 2022

This study is currently active again.

mango · May 2, 2022

Recovered ME-patient Björn Eklund recently mentioned Axelsson's research in a blog post:

https://bjorneklund.se/utan-jonas-axelsson-hade-jag-inte-kunnat-gora-den-har-vandringen/

Auto-translate said:

They have found something very interesting, a genetic variant that they think may explain the risk of contracting paraviral diseases, such as ME and long covid.
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Auto-translate said:

I came into contact with the immunologist, doctor and researcher Jonas Axelsson when I got much better after the Rituximab treatment in Norway. He was then working full-time at Karolinska Hospital. I emailed him after listening to a young girl with ME in the P1 [radio] documentary programme. Jonas was in the documentary. And got a reply.

Hi Björn,
Thanks for the email! Has anyone tried treating your herpes viruses (EBV and CMV) for e.g. 6 months with valganciclovir. My experience is that it can help patients who responded to Rituximab.
Regards, Jonas

He was right. I got on antiviral medication, started eating it, and got even better. Since then he has helped me a lot and I can now say that I am 100% healthy. Without his help I would not have made this trek.
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mango · May 2, 2022

A news article from 2020

Klinik forskade om långtidscovid utan tillstånd
https://www.svt.se/nyheter/vetenskap/klinik-forskade-om-langtidscovid-utan-tillstand

Auto-translate said:

Clinic researched long covid without permission

Updated 17 November 2020 Published 29 October 2020

In the absence of treatment for long covid, patients have turned to a private clinic in Stockholm that offers experimental treatment. Research has also been conducted on patients there without ethical approval, reveals [the TV programme] Vetenskapens Värld.

Word of the private clinic Red clinic that treats covid-19 has spread online among sufferers who travel to Stockholm from all over the country. One patient says she has been promised a cure within two years. It costs several thousand kronor for patients to be examined and treated at the clinic, as it does not have an agreement with the region [the local government that is responsible for the healthcare system].

Scientifically unproven theory of long covid

The clinic's founder, doctor Jonas Axelsson, also works as an immunologist at Karolinska University Hospital. He has a theory that long-term sufferers have a hereditary vulnerability and a chronic herpes infection that causes their immune system to run amok when infected by covid-19.

- After all, our study is aimed at finding out if we can find any support for residual coronavirus activity in the body. The first idea was that we would have 50 [patients], but we had already filled that number three times in the first week, so now we've said maybe 350, and I think we'll reach that,' says Jonas Axelsson.

Research lacks ethical approval

Jonas Axelsson has been collecting blood samples, throat swabs, stool and disease data from patients since last summer. Despite the fact that the study lacks approval from the Ethical Review Authority, the body that assesses that subjects are not harmed.

Research on patients without ethics approval could lead to prosecution.

- I can't answer this because I don't know anything about this, I only know that I have ethics approval, Jonas Axelsson replies when Vetenskapens värld confronts him with the information.

Jonas Axelsson is in charge of the two studies investigating co-infected patients and applied for a licence last summer from the Ethical Review Authority at the same time as he started the research instead of waiting for a decision.

(Update 2020-11-17): The Ethical Review Authority did not grant authorisation for the two studies in question until 3 November 2020. The Ethical Review Appeals Board has requested information from Jonas Axelsson in order to decide whether to file a police report.

The studies have been stopped following the revelation

Jonas Axelsson returns the call and says he will report himself to the police. Later, in a letter, he retracts his statement that he had conducted research without permission. According to the clinic's website, the study has been stopped after the revelation by Vetenskapens värld.

Patients at risk of harm

Physician and covid researcher Petter Brodin at Karolinska Institutet is outraged when he hears about the research without ethical approval and treatment with drugs not tested for covid-19.

- It's worrying, I think. These are people who are very vulnerable, who are desperate, which I understand very well, and who risk getting into trouble and receiving treatments that may have a lot of side effects, but do not work, says Petter Brodin.

See more in The World of Science - Corona, hope and despair on SVTplay and 2 November at 20:00 on SVT2.

The studies that do not have an Ethical Review Authority licence are: 1. The Scandinavian Post-CoVID Cohort Study. 2. Tissue banking and characterisation of biological material from patients with retroviral associated diseases (RED)
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mango · May 2, 2022

Research project title: Vävnadsbankning och karakterisering av biologiskt material ifrån patienter med retroviralt associerade sjukdomar (RED)

In English, something like "Tissue banking and characterization of biological material from patients with retrovirally associated diseases (RED)"

Some more auto-translated info from the ethical approval application:

Lay summary:

The diagnoses of fibromyalgia, myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) and postural orthostatic tachycardia syndrome (POTS) are common and cause great suffering and loss of work hours. Today, there is a lack of biological understanding of the causes of the disease and knowledge of the risk factors, as well as a lack of effective treatment.

At the RED Clinic, we work on the basis of science and proven experience to identify the physiological causes of these diagnoses in order to provide better care.

Our research is done in collaboration with some of Sweden's leading experts in ME (Prof Jonas Bergquist in Uppsala) and POTS (Dr Artur Fedorowski in Malmö) and has led to the hypothesis that congenital mutations in combination with retroviral activity (RED) cause disease.

We now wish to be allowed to take samples from voluntary, informed patients to investigate this hypothesis and to link it to the severity of symptoms and the effect of treatment.

Furthermore, we would like permission to store leftover material in a biobank.
Click to expand...

What is the scientific aim of the project?

In two recent evidence reviews on ME/CFS (ref. 2018/375) and fibromyalgia (ref. 2018/519) commissioned by the government, the Swedish Agency for Health Technology Assessment (SBU) states that although the diagnoses have been known for >70 years, the causes behind the conditions are still completely unknown.

The diagnoses have significant similarities, with a chronic pain condition characterised by prolonged and widespread generalised pain and tenderness, sleep disturbance and excessive fatigue, and very slow recovery from minimal exertion. The pain is felt mainly in the head, face and muscles, but joint pain also occurs. More than 7 out of 10 patients are women.

Our project aims to identify the extent to which the disease mechanisms in ME/POTS, fibromyalgia and POTS are the same, and the extent to which viral activity is present in each of the three.

To investigate this, we wish to build on the findings of two previously Swedish Ethical Review Authority approved studies in which material has been collected from POTS (SYSTEMA-POTS) and ME patients (DI-2019).

As these studies have identified common variants in genes encoding proteins involved in antiviral activity, and evidence of impaired function of these in blood cells, we now wish to prospectively sample new patients at our clinic in order to build a large enough biobank to draw robust conclusions about similarities and differences between the diagnoses.

We also intend to advertise for patients with attached advertisement for the same purpose.
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What are the scientific questions?

1. Can preliminary findings of amino acid-swapping gene mutations in genes encoding RNA-binding proteins be confirmed in a larger sample, and if so, does the prevalence of these differ between the three subdiagnoses in the study?

2. Can the distribution and dysfunction of immune cells in whole blood that appear to be characteristic of the disease group be confirmed in a larger sample, and if so, does this differ between the three subdiagnoses in the study?

3. Does the observed incidence or activity of viruses differ in isolated blood cells (as previously described) and other cells collected in the study (epithelial cells from nasal and cheek mucosa, intestinal cells from faeces and epithelial cells from urine)? Does this relate to the presence of mutations examined in 1?

4. Can evidence of mitochondrial dysfunction (reduced membrane potential) be detected in any of the cell types studied, and if so, does it correlate with mutations from 1, immunological activity from 2 or viral occurrence according to 3?

5. Is the viral activity or mitochondrial function, if measured, affected in patients when they take any of the empirically tested drugs used for these patient groups and, if so, does this effect correlate with symptom relief?
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mango · May 2, 2022

Here's a link to the full original ethical approval application from August 2020, in Swedish (pdf, 25 pages, 23MB).

https://www.dropbox.com/s/19h3qmqqmsvzegz/Grundansökan-AnsökanME.pdf?dl=0

(I haven't checked recently if there are any new or updated applications related to this study or this researcher.)

mango · May 4, 2022

mango said: ↑

(I haven't checked recently if there are any new or updated applications related to this study or this researcher.)
Click to expand...

An update on this. The Swedish Ethical Review Authority has not received any new applications from Ameliekliniken or Jonas Axelsson.

mango · May 4, 2022

A project description in English, including methods etc, is available to download through the link below.

The name of the file is "Grundansökan-Bilaga4-Scientific program (1).pdf"

https://www.dropbox.com/sh/jywkzl96xvhlyex/AACcILy6k5sQ0Hsai8FWz0wla?dl=0

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Closed Sweden 2022: The REDBANK Study - Amelieklinikin (was RED Clinic) Jonas Axelsson

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