Academically strong project team
The project manager of the research project is Dr. Mette Johnsgaard, general manager, physician and researcher at Lillestrøm Health Clinic. She has a very strong project team with her:
- Professor Ola Didrik Saugstad, Rikshospitalet University Hospital in Oslo. (Supervisor of the research study)
Researcher Prof. Dr. Med Judy Mikovits, director of research Whittemore-Peterson Institute (WPI), Reno i USA.
Researcher Dr. Med. Mauro Malnati, group manager for human virology at the San Raffaele Scientific Institute in Milano, Italia.
Researcher and physician Dr. Ingrid Lund, Lillestrøm Health Clinic
Researcher and physician Dr. Sigrid Holterman Holmen, Lillestrøm Health Clinic
The project started in October 2010 and is estimated to last until april 2011. The project is financed by Lillestrøm Health Clinic and the other participating research institutes.
According to the project description, the hypothesis to be studied are:
“Patients with severe, disabling ME/CFS have an ongoing MLV-related virus infection that is the main reason for their disease. Close relatives may or may not also have a latent retroviral infection. We want to look further info differences between extremely disabled patients, healthy relatives, and healthy controls in retroviral prevalence.
We will also look into markers for immune dysfunction including cytokine profiles, and also antibody detection. We believe it is possible to find biomarkeds that can be used to follow the disease.
We believe it is possible that the retroviral reservoir is the B cells. This can explain the positive effect of rituximab. Mature B cells expressing the CD20 will then have to carry the major retroviral load. However, as immature B cells emerge from stem cells in the bone marrow and plasma cells, the increasing retroviral load contributes to the increasing symptoms reappering as the effect of rituximab lessens over time.”
The project is approved by the Regional comitte for research ethics in medicine in Norway.
Dr. Johnsgaard says the following about the background of the study:
ME/CFS is a disease with unknown ethiology, and may lead to severe symptoms and permanent reduced function and disablement. Dysregulation of the immune system is a possible pathogenetic factor. The last year, two strong studies has been published showing a possible connection between murine leukemia virus-related viruses and ME/CFS, though it is still uncertainty if the findings are specific and relevant for the disease. Norway has, in addition to a larger prevalence of the disease, also a large number of patients with ME/CFS who are extremely ill (mostly bedbound, with a Karnofsky score of 40 or below.)
We want to compare findings from these patients with healthy controls. In addition to looking for gene sequences from MLV-related viruses, we will look for other caracteristics in the immune-system cells that can give us a broader understanding of the disease. This study will be very important in starting any treatment trials.
The statement from Dr. Johnsgaard shows that they not only wants to look at how MLV-related viruses are involved in the understanding of ME/CFS, but that they also have a broader plan about starting possible treatment trials. This is knowledge that not only will benefit the patients at Lillestrøm Health Clinic, but alle ME/CFS-patient! With biomedical research on the table from the Norwegian patient population it will be hard for Norwegian health authorities to ignore biomedical mechanisms and necessary treatment of such.
The 29 patients included in the study have a known ME/CFS-diagnosis based on the Canadian criteria, and substantial reduced functional capacity with a Karnofsky-score of 40 or below. Children under the age of 12 is also included in the study.
A group of healthy controls with close contact with the patient is also included (family members etc.) and a control group of healthy individuals without contact with patients. (Total of 33 persons.)
Blood samples of patients will be independently analysed in laboratories both in Italy (San Raffaele Scientific Institute) and in USA (WPI).
The full project description can be read here http://bit.ly/frUoxw (In English!)
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