Als iemand u een vaccin dat je fibromyalgie zou genezen kon geven, zou je het doen? Dat klinkt misschien als een droom, maar het is dichter bij de realiteit dan je zou denken. Los Angeles-gebaseerd biomedisch bedrijf EpicGenetics en Massachusetts General Hospital onderzoekers zijn op zoek naar goedkeuring van de Amerikaanse Food and Drug Administration (FDA) om een klinische proef volgend jaar op de proef Bacillus Calmette-Guerin (BCG) vaccin als een potentiële behandeling voor fibromyalgie.
BCG is een generieke tuberculose-vaccin, dat is bijna een 100 jaar oud en is veilig toegediend miljoenen keren,”verklaarde Dr. Denise Faustman, hoofd van de Faustman Lab van het Massachusetts General Hospital. “Al meer dan 10 jaar, onze onderzoeksgroep in het Massachusetts General Hospital zijn actief onderzoek naar de rol die de BCG-vaccin zou kunnen spelen bij de behandeling van verschillende vormen van auto-immuniteit. Onze huidige focus is type 1 diabetes, maar ook wereldwijd BCG wordt getest in een aantal auto-immuunziekten. In de komende twee jaar zullen we de klinische testen van BCG in fibromyalgie te beginnen.”
Volgens de World Health Organization, zijn meer dan 100 miljoen kinderen, gezien de BCG-vaccin elk jaar. Het wordt voornamelijk gebruikt in ontwikkelingslanden waar tuberculose nog steeds actief is. De BCG-vaccin is niet beschikbaar in de Verenigde Staten vanwege de lage risico van infectie. In de VS wordt BCG gebruikt in een klein aantal patiënten voor de behandeling van blaaskanker.
Dus, voor de hand liggende vraag is waarom zou een vaccin voor een besmettelijke longziekte worden gebruikt voor fibromyalgie? Het antwoord ligt in het immuunsysteem.
Vaccins worden meestal gegeven aan gezonde mensen om infectie te voorkomen. In dit geval echter, het BCG-vaccin zou worden toegediend aan patiënten met fibromyalgie in een poging om hun symptomen te onderdrukken.
Toen EpicGenetics werd belast met het creëren van een diagnostische test voor fibromyalgie enkele jaren geleden, onderzoekers liep allerlei lab tests op fibromyalgie patiënten om erachter te komen hoe zij verschilden van gezonde controlepersonen en wat de mogelijke oorzaak van hun symptomen. De onderzoekers ontdekten een aantal witte bloedcellen afwijkingen in fibromyalgie-patiënten, waardoor ze symptomen gepaard met een onderdrukt immuunsysteem te sluiten.
“Wij geloven dat [de term] fibromyalgie is een verkeerde benaming,” zei Dr Bruce Gillis, CEO EpicGenetics’. “Deze mensen zijn niet lijden aan iets dat van invloed is op de spieren, per zeggen. Wat ze lijden aan is hun immuunsysteem kan geen normale hoeveelheden beschermende eiwitten. … Er zijn cellen in het immuunsysteem genoemd perifeer bloed mononucleaire cellen. Ze zijn niet de productie van normale hoeveelheden van de beschermende eiwitten genaamd chemokines en cytokines.”
De constatering heeft geleid tot de ontwikkeling van de FM / een bloedtest voor fibromyalgie. (Ja, ondanks wat uw arts kan u gezegd hebben, is er een bloedtest voor fibromyalgie! Het is gewoon niet op grote schaal in de medische gemeenschap geaccepteerd.) De test analyseert de niveaus van vier chemokines en cytokines gevonden op lagere niveaus bij fibromyalgie patiënten. Deze vier chemokines en cytokines toevallig dezelfde als degene die worden versterkt door de BCG-vaccin.
“Gezien wat er in de medische literatuur gepubliceerd, we geloven dat dit vaccin zal het immuunsysteem afwijkingen [van fibromyalgie] te keren”, zegt Gillis.
Gillis en Faustman zijn op zoek naar FDA goedkeuring aan de eerste BCG vaccins om fibromyalgie patiënten beheren begin volgend jaar.
“Dit is de eerste keer dat een directe behandeling van fibromyalgie zal gebeuren”, aldus Gillis. “Zoals u weet, de medicijnen die [die momenteel op de markt] voor fibromyalgie alleen de behandeling van de symptomen. Ze hebben geen immuunsysteem voordelen. [De farmaceutische bedrijven] toe te geven dat ze alleen de behandeling van symptomen, maar je moet de behandeling van de ziekte, en dat is de reden waarom we vooruit gaan verhuizen met het vaccin toepassing [de FDA].”
Als Gillis theorie geldt, dan ‘de chemokines en cytokines die deficiënt zijn in patiënten met fibromyalgie zal niet langer deficiënt zijn [zodra de BCG-vaccin wordt toegediend],’ aldus Gillis. “Het productieniveau zal normaliseren, en je hebt om aan te nemen dan is dat hun symptomen verdwijnen. … We denken dat we aan de vooravond van iets grote.”
Omdat het vaccin heeft zo’n lange geschiedenis, is het naar verwachting geen ernstige bijwerkingen veroorzaken bij patiënten.
De BCG-vaccin is naar verwachting kosten $ 20- $ 25 per dosis – een nominaal bedrag in vergelijking met de lopende kosten van het nemen van geneesmiddelen elke dag.
“We denken dat een fibromyalgie patiënt zou maximaal één of twee doses nodig hebt, zodat u kunt begrijpen waarom ik niet krijgen veel steun van farmaceutische bedrijven,” aldus Gillis.
In aanvulling op het vaccin proef, EpicGenetics werkt samen met de Universiteit van Californië, Los Angeles (UCLA) en de Universiteit van Illinois College of Medicine in Chicago om het genoom van tot 250.000 fibromyalgie patiënten te sequencen.
“We zijn op zoek voor elk type van genetische patronen of afwijkingen of mutaties”, zegt Gillis.
Patiënten die positief voor fibromyalgie te testen met de FM / een test in staat zal zijn om deel te nemen in de genomische studie.
De FM / een test kost momenteel $ 936, maar wordt gedekt door sommige verzekeringsmaatschappijen en Medicare. EpicGenetics’ support team helpt patiënten bepalen of hun verzekeringsmaatschappij de test zal dekken. Een no-rentebetaling plan is beschikbaar voor mensen die onverzekerd zijn of waarvan de verzekering zal de test niet te dekken.
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