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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003ECurrent treatment for Parkinson\u0027s disease (PD) using dopamine agents to replace the loss of dopaminergic neurons has helped to ameliorate some of the motor features of the disease in its early stages. This significant response to dopamine agents has provided the rationale for testing cell-based therapies for replacement of lost dopamine neurons in the hope of altering the natural history of PD by slowing the progression of signs and symptoms. This article discusses the current research on cell transplantation as therapy for PD and discussed the prospects for using stem-cell therapy for clinical transplantation\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EExtrapyramidal \u0026amp; Movement Disorders Genomics\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EExtrapyramidal \u0026amp; Movement Disorders\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology Genomics\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003ENeurology\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ECurrent treatment for Parkinson\u0027s disease (PD) using dopamine agents to replace the loss of dopaminergic neurons has helped to ameliorate some of the motor features of the disease in its early stages. This significant response to dopamine agents has provided the rationale for testing cell-based therapies for replacement of lost dopamine neurons in the hope of altering the natural history of PD by slowing the progression of signs and symptoms.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EA panel of experts reflected on lessons learned from the current research on cell transplantation as therapy for PD and discussed the prospects for using stem-cell therapy for clinical transplantation.\u003C\/p\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-1\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EOPEN-LABEL CELL TRANSPLANTATION STUDIES\u003C\/h2\u003E\n         \u003Cp id=\u0022p-4\u0022\u003ERoger Barker, MD, University of Cambridge, Cambridge, United Kingdom, discussed lessons learned from the open-label cell transplantation studies to replace the lost dopamine cells found in PD. The standard process by which cell-based therapies are moved forward to patients is to identify a cell source that produces dopamine, test it in an animal model of PD, trial it in a small open-label study, optimize procedures in open-label studies, and, finally, conduct a double-blind sham surgery trial. Dr. Barker presented data on a number of cell sources that have been investigated, including adrenal medulla, porcine fetal ventral mesencephalic tissue, Spheramine\u00ae, and human fetal ventral mesencephalic tissue.\u003C\/p\u003E\n         \u003Cp id=\u0022p-5\u0022\u003ELessons learned from these trials include the following:\u003C\/p\u003E\n         \u003Cul class=\u0022list-simple \u0022 id=\u0022list-1\u0022\u003E\u003Cli id=\u0022list-item-1\u0022\u003E\n               \n               \u003Cp id=\u0022p-6\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003EEach cell therapy is different from the others.\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-2\u0022\u003E\n               \n               \u003Cp id=\u0022p-7\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003EA critical look at the preclinical data is required because those data will accurately predict clinical response.\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-3\u0022\u003E\n               \n               \u003Cp id=\u0022p-8\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003EIt takes time to optimize how to best use a cell therapy; open-label studies rarely get it right the first time and so require learning along the way as well as cooperation among participants.\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-4\u0022\u003E\n               \n               \u003Cp id=\u0022p-9\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003EAll trials should include long-term follow-up, which is necessary to obtain data regarding true efficacy.\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-5\u0022\u003E\n               \n               \u003Cp id=\u0022p-10\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003EDouble-blind placebo\/sham surgery trials should be considered only after knowing how to use the cell therapy optimally.\u003C\/p\u003E\n            \u003C\/li\u003E\u003C\/ul\u003E\n         \u003Cp id=\u0022p-11\u0022\u003EProf. Barker then described a study currently underway\u2014the Transeuro Open Label Transplant Study in Parkinson\u0027s Disease [Transeuro; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01898390\u0026amp;atom=%2Fspmdc%2F14%2F15%2F21.atom\u0022\u003ENCT01898390\u003C\/a\u003E]\u2014which has been designed to incorporate the preceding lessons from prior studies. This open-label study is designed to optimize the characteristics of patients who are anticipated to respond best to fetal ventral mesencephalic tissue transplantation\u2014that is, younger patients with earlier disease. The study is about to transplant its first patient and will run until 2018.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-2\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003ESHAM-CONTROLLED CLINICAL TRIALS\u003C\/h2\u003E\n         \u003Cp id=\u0022p-12\u0022\u003EStanley Fahn, MD, Columbia University Medical School, New York, New York, USA, reflected on the results of the 2 sham-controlled clinical trials using fetal cells [Olanow CW et al. \u003Cem\u003EAnn Neurol\u003C\/em\u003E 2003; Freed CR et al. \u003Cem\u003EN Engl J Med\u003C\/em\u003E 2001].\u003C\/p\u003E\n         \u003Cp id=\u0022p-13\u0022\u003EDr. Fahn began with an overview of the historical perspective, including a discussion of doubts regarding the ethics of doing sham-controlled clinical trials. Dr. Fahn also noted that one lesson gleaned from this work is that sham-controlled surgical trials are possible and that blinding can be obtained and maintained throughout the study.\u003C\/p\u003E\n         \u003Cp id=\u0022p-14\u0022\u003EMajor findings of the studies include the following:\u003C\/p\u003E\n         \u003Cul class=\u0022list-simple \u0022 id=\u0022list-2\u0022\u003E\u003Cli id=\u0022list-item-6\u0022\u003E\n               \n               \u003Cp id=\u0022p-15\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003ESubjective self-ratings after 1 year are unreliable. After 1 year, people tend not to recall the severity of their illness. A more accurate self-assessment can be made by having patients review a video of themselves.\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-7\u0022\u003E\n               \n               \u003Cp id=\u0022p-16\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003EIt is more difficult to achieve improvement in global self-rating than improvement in Unified Parkinson\u0027s Disease Rating Scale score.\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-8\u0022\u003E\n               \n               \u003Cp id=\u0022p-17\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003EFetal dopaminergic tissue implants can survive and provide long-lasting dopaminergic effect.\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-9\u0022\u003E\n               \n               \u003Cp id=\u0022p-18\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003EPatients with persistent dyskinesias had the greatest significant improvement, with both the presence of dyskinesias and their subsequent improvement reflecting dopaminergic activity.\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-10\u0022\u003E\n               \n               \u003Cp id=\u0022p-19\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003ECurrently, immunosuppression is not thought to be essential, although Dr. Fahn thinks that it may still be critical in the majority of patients, as it may help with better survival and a better result.\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-11\u0022\u003E\n               \n               \u003Cp id=\u0022p-20\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003ESymptom relief is not guaranteed by image-detected survival of dopaminergic neurons.\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-12\u0022\u003E\n               \n               \u003Cp id=\u0022p-21\u0022\u003E\u003Cspan class=\u0022list-label\u0022\u003E\u25aa \u003C\/span\u003EFuture research studies on transplantation should be considered for young patients with early PD, before they develop levodopa dyskinesias.\u003C\/p\u003E\n            \u003C\/li\u003E\u003C\/ul\u003E\n         \u003Cp id=\u0022p-22\u0022\u003EDr. Fahn ended by emphasizing that sham-controlled trials are essential to truly test the effectiveness of cell therapies for PD.\u003C\/p\u003E\n      \u003C\/div\u003E\u003Cdiv class=\u0022section\u0022 id=\u0022sec-3\u0022\u003E\n         \u003Ch2 class=\u0022\u0022\u003EPROSPECTS: LOOKING AHEAD\u003C\/h2\u003E\n         \u003Cp id=\u0022p-23\u0022\u003EThe session ended with a discussion by Prof. Barker on the issues that need to be addressed to move cell therapy for PD forward, highlighting four main questions:\u003C\/p\u003E\n         \u003Col class=\u0022list-ord \u0022 id=\u0022list-3\u0022\u003E\u003Cli id=\u0022list-item-13\u0022\u003E\n               \u003Cp id=\u0022p-24\u0022\u003EDo dopamine cell therapies work for PD?\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-14\u0022\u003E\n               \u003Cp id=\u0022p-25\u0022\u003ECan stem cells safely be made into authentic nigral dopaminergic neurons?\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-15\u0022\u003E\n               \u003Cp id=\u0022p-26\u0022\u003EHow can such therapies be tested in patients?\u003C\/p\u003E\n            \u003C\/li\u003E\u003Cli id=\u0022list-item-16\u0022\u003E\n               \u003Cp id=\u0022p-27\u0022\u003EAre these therapies competitive?\u003C\/p\u003E\n            \u003C\/li\u003E\u003C\/ol\u003E\n         \u003Cp id=\u0022p-28\u0022\u003EReferring back to his talk at the start of the session, Prof. Barker said that the studies have shown that dopamine cell therapies do work for PD but that a lot will rest on the findings of the Transeuro trial. Studies also need to show that the stem cells are able to yield authentic nigral dopaminergic neurons, which can be made using good manufacturing practices and regulation and are safe with good fiber outgrowth.\u003C\/p\u003E\n         \u003Cp id=\u0022p-29\u0022\u003EAs for testing cell therapy in patients, the Transeuro study is helping to shape the type of trial needed. A number of strategic grants have been given to investigators in several countries worldwide, and the close collaboration among these investigators will help answer the critical questions that will move cell therapy into the clinic. A stem cell source will be ready for clinical trial in the next 5 years, but there are still unresolved issues on how to translate the emerging preclinical data into a clinical trial (eg, which patients to include, trial design). How to regulate stem cell therapy trials has been and will continue to be a major concern.\u003C\/p\u003E\n         \u003Cp id=\u0022p-30\u0022\u003EThe final issue will be to determine whether a cell-based therapy is better than any other therapies for PD in terms of efficacy, cost, and effect on natural history of the disease. Prof. Barker emphasized the inevitable changes once commercial investment enters the picture, which may affect the timeline of these therapies as well as outcomes.\u003C\/p\u003E\n         \u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/15\/21\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022The editors would like to thank the many members of the 2014 Movement Disorder Society meeting presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1555469586\u0022 data-figure-caption=\u0022The editors would like to thank the many members of the 2014 Movement Disorder Society meeting presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure1\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/15\/21\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/15\/21\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure1\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/15\/21\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/14558\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\n               \u003Cp id=\u0022p-31\u0022 class=\u0022first-child\u0022\u003EThe editors would like to thank the many members of the 2014 Movement Disorder Society meeting presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u003C\/p\u003E\n            \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\n      \u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/15\/21.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzp4i1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzp4i1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}