| pubmed-article:19931408 | rdf:type | pubmed:Citation | lld:pubmed |
| pubmed-article:19931408 | lifeskim:mentions | umls-concept:C0030705 | lld:lifeskim |
| pubmed-article:19931408 | lifeskim:mentions | umls-concept:C0332307 | lld:lifeskim |
| pubmed-article:19931408 | lifeskim:mentions | umls-concept:C0021083 | lld:lifeskim |
| pubmed-article:19931408 | lifeskim:mentions | umls-concept:C0011854 | lld:lifeskim |
| pubmed-article:19931408 | lifeskim:mentions | umls-concept:C0021641 | lld:lifeskim |
| pubmed-article:19931408 | lifeskim:mentions | umls-concept:C0039198 | lld:lifeskim |
| pubmed-article:19931408 | lifeskim:mentions | umls-concept:C0205263 | lld:lifeskim |
| pubmed-article:19931408 | pubmed:issue | 4 | lld:pubmed |
| pubmed-article:19931408 | pubmed:dateCreated | 2010-4-26 | lld:pubmed |
| pubmed-article:19931408 | pubmed:databankReference | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:19931408 | pubmed:abstractText | There is a growing body of evidence to suggest that the autoimmunity observed in type 1 diabetes mellitus (T1DM) is the result of an imbalance between autoaggressive and regulatory cell subsets. Therapeutics that supplement or enhance the existing regulatory subset are therefore a much sought after goal in this indication. Here, we report the results of a double blind, placebo controlled, phase I clinical trial of a novel antigen-specific therapeutic in 12 subjects with recently diagnosed T1DM. Our primary objective was to test its safety. The study drug, human insulin B-chain in incomplete Freund's adjuvant (IFA) was administered as a single intramuscular injection, with subjects followed for 2 years. All subjects completed therapy and all follow-up visits. The therapy was generally safe and well-tolerated. Mixed meal stimulated C-peptide responses, measured every 6 months, showed no statistical differences between arms. All patients vaccinated with the autoantigen, but none who received placebo, developed robust insulin-specific humoral and T cell responses. Up to two years following the single injection, in peripheral blood from subjects in the experimental arm, but not the control arm, insulin B-chain-specific CD4+ T cells could be isolated and cloned that showed phenotypic and functional characteristics of regulatory T cells. The induction of a lasting, robust immune response generating autoantigen-specific regulatory T cells provides strong justification for further testing of this therapy in type 1 diabetes. (clinicaltrials.gov identifier NCT00057499). | lld:pubmed |
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| pubmed-article:19931408 | pubmed:language | eng | lld:pubmed |
| pubmed-article:19931408 | pubmed:journal | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:19931408 | pubmed:citationSubset | IM | lld:pubmed |
| pubmed-article:19931408 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:19931408 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:19931408 | pubmed:status | MEDLINE | lld:pubmed |
| pubmed-article:19931408 | pubmed:month | Jun | lld:pubmed |
| pubmed-article:19931408 | pubmed:issn | 1095-9157 | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:ReijonenHelen... | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:OrbanTihamerT | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:MatthewsJeffr... | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:WolfsdorfJose... | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:FalkBenB | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:TreszlAndrasA | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:RickerAlyneA | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:KisJanosJ | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:FarkasKlaraK | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:JalahejHeyamH | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:SayrePeterP | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:TchaoNadioN | lld:pubmed |
| pubmed-article:19931408 | pubmed:author | pubmed-author:BianchinePete... | lld:pubmed |
| pubmed-article:19931408 | pubmed:issnType | Electronic | lld:pubmed |
| pubmed-article:19931408 | pubmed:volume | 34 | lld:pubmed |
| pubmed-article:19931408 | pubmed:owner | NLM | lld:pubmed |
| pubmed-article:19931408 | pubmed:authorsComplete | Y | lld:pubmed |
| pubmed-article:19931408 | pubmed:pagination | 408-15 | lld:pubmed |
| pubmed-article:19931408 | pubmed:dateRevised | 2011-11-17 | lld:pubmed |
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