Vacina dá nova esperança Centennial comunidade de fibromialgia

Por Donna Gregory Burch Se alguém poderia dar uma vacina que curá-la fibromialgia, não é? Isso pode soar como um sonho, mas é mais próximo da realidade do que você imagina. EpicGenetics firmes biomédicas e pesquisadores do Hospital Geral de Massachusetts estão buscando a aprovação da Food and Drug Administration (FDA) para realizar um ensaio clínico no próximo ano para testar a vacina Bacilo de Calmette-Guerin (BCG ) como um tratamento potencial para a fibromialgia.
“A BCG é uma vacina contra a tuberculose genérico que tem quase 100 anos e tem sido administrada com segurança milhões de vezes”, disse Denise Faustman, diretor do Laboratório Faustman do Massachusetts General Hospital. “Por mais de 10 anos, nosso grupo de pesquisa no Massachusetts General Hospital vem investigando ativamente o papel que a vacina BCG pode desempenhar no tratamento de várias formas de auto-imunidade. Nosso foco atual é o diabetes tipo 1, mas BCG geral está sendo testado em uma série de doenças auto-imunes. Nos próximos dois anos vamos começar os testes clínicos de BCG na fibromialgia “.
De acordo com a Organização Mundial de Saúde, mais de 100 milhões de crianças recebam a vacina BCG a cada ano. É usado principalmente em países em desenvolvimento onde a tuberculose é ainda ativo. A vacina BCG não está disponível nos Estados Unidos por causa do baixo risco de infecção. Nos Estados Unidos, a BCG é utilizada em um pequeno número de pacientes para o tratamento do cancro da bexiga.
Assim, a pergunta óbvia é por uma vacina para uma doença pulmonar infecciosa é usado para a fibromialgia? A resposta é dentro do sistema imunológico.
As vacinas são geralmente dada a pessoas saudáveis para prevenir a infecção. Neste caso, no entanto, a vacina BCG para pacientes com fibromialgia administrada em um esforço para acabar com os seus sintomas.
Quando EpicGenetics foi contratado para criar um teste de diagnóstico para a fibromialgia por vários anos, os pesquisadores realizaram todos os tipos de exames laboratoriais em pacientes com fibromialgia para descobrir como eles diferiam dos controles saudáveis e que poderia estar causando os sintomas. Os investigadores encontraram vários anormalidades das células brancas do sangue em doentes com fibromialgia, o que leva -los para concluir que os sintomas estão associados com um sistema imunitário suprimido.
“Acreditamos que [o termo] A fibromialgia é um equívoco , ” disse o Dr. Bruce Gillis, CEO da EpicGenetics. “Essas pessoas não estão sofrendo com tudo o que está afetando os músculos, para dizer. O que está sofrendo é que seu sistema imunológico não pode produzir quantidades normais de proteínas protetoras. … Há células do sistema imunológico chamadas células mononucleares do sangue do sangue periférico. Eles não estão produzindo quantidades normais de proteínas protetoras chamadas quimiocinas e citocinas “.
A descoberta levou para o desenvolvimento da análise FM / a para a fibromialgia. O teste parece em níveis de quatro quimiocinas e citoquinas encontradas em níveis reduzidos em pacientes com fibromialgia. Estes quatro quimiocinas e citoquinas são as mesmas que são alimentados por vacinação BCG.
“Dado o que foi publicado na literatura médica, acreditamos que esta vacina vai reverter as anormalidades do sistema imunológico [fibromialgia] , ” disse Gillis.
Gillis e Faustman estão buscando a aprovação da FDA para administrar as primeiras vacinas BCG pacientes com fibromialgia no início do próximo ano.
“Esta é a primeira vez que um tratamento direto da fibromialgia é feito , ” disse Gillis. “Como você sabe, drogas [no mercado] para a fibromialgia apenas tratar os sintomas. Eles não têm benefícios do sistema imunológico. [As empresas farmacêuticas] reconhecer que eles são apenas tratar os sintomas, mas você precisa para tratar a doença, e que é por isso que estamos a avançar com a implementação do [FDA] “vacina.
Gillis Se a teoria é verdadeira, então “quimiocinas e citocinas que são deficientes em pacientes com fibromialgia vai deixar de ser deficiente [uma vez que a vacina é administrada BCG] , ” disse Gillis. “Os níveis de produção irá normalizar, e, em seguida, temos de assumir que os sintomas desaparecem. … Acreditamos que estamos à beira de algo importante. ”
Como a vacina tem uma longa história, é não deve causar efeitos colaterais significativos em pacientes.
Prevê-se que os custos de vacinação BCG entre 20 e 25 dólares por dose, uma quantidade nominal quando comparada com a despesa continua de drogas tendo cada dia.
“Acreditamos que um paciente fibromialgia seria preciso uma ou duas doses máximas para que você possa entender por que eu não estou recebendo muito apoio de empresas farmacêuticas , ” disse Gillis.
Em adição às vacinas de teste, EpicGenetics é uma parceria com a Universidade da Califórnia, Los Angeles (UCLA) e da Universidade de Illinois College of Medicine Chicago para sequenciar os genomas de 250.000 pacientes com fibromialgia.
“Nós estamos olhando para quaisquer padrões ou anomalias ou mutações genéticas , ” disse Gillis.
Os pacientes com teste positivo para a fibromialgia por FM / um teste genômico podem participar estudo Inthe. atualmente FM / teste custa US $ 936, mas é coberto por algumas companhias de seguros e Medicare. A equipe de suporte EpicGenetics ajuda os pacientes a determinar se sua companhia de seguros vai cobrir o teste. Um interesse – plano de pagamento está disponível gratuitamente para as pessoas que não têm seguro ou cujo seguro será não cobrir o teste.

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