{"id":22741,"date":"2015-10-09T10:31:48","date_gmt":"2015-10-09T08:31:48","guid":{"rendered":"http:\/\/www.invarena.cz\/?p=22741"},"modified":"2015-10-09T10:31:56","modified_gmt":"2015-10-09T08:31:56","slug":"ksefty-s-lecbou-kloubu-konci-ln","status":"publish","type":"post","link":"https:\/\/www.invarena.cz\/?p=22741","title":{"rendered":"K\u0161efty s l\u00e9\u010dbou kloub\u016f kon\u010d\u00ed"},"content":{"rendered":"<p><strong>Nov\u00e9 terapie kmenov\u00fdmi bu\u0148kami budou muset nejd\u0159\u00edv prok\u00e1zat svou \u00fa\u010dinnost<\/strong><!--more--><\/p>\n<p>foto: Flickr.com<\/p>\n<p>Lukrativn\u00ed byznys se spornou l\u00e9\u010dbou kmenov\u00fdmi bu\u0148kami m\u00e1 na kah\u00e1nku. Zamez\u00ed mu evropsk\u00e9 i \u010desk\u00e9 \u00fa\u0159ady, kter\u00e9 na jejich pou\u017e\u00edv\u00e1n\u00ed vydaly nov\u00e1 pravidla.<br \/>\n&#8222;Komer\u010dn\u00ed l\u00e9\u010dba nap\u0159\u00edklad artr\u00f3zy kmenov\u00fdmi bu\u0148kami by se nyn\u00ed m\u011bla zastavit,&#8220; zd\u016fraz\u0148uje \u0161\u00e9fka Koalice pro zdrav\u00ed Jana Petrenko. Tuto terapii nab\u00edzej\u00ed des\u00edtky soukrom\u00fdch ordinac\u00ed. Za jednor\u00e1zovou aplikaci kmenov\u00fdch bun\u011bk si \u00fa\u010dtuj\u00ed od 30 tis\u00edc korun.<br \/>\nStejn\u00fd n\u00e1zor sd\u00edl\u00ed i specialista na l\u00e9kovou politiku a exn\u00e1m\u011bstek St\u00e1tn\u00edho \u00fa\u0159adu pro kontrolu l\u00e9\u010div Filip Vrubel ze spole\u010dnosti Deloitte. &#8222;Nejen\u017ee \u017e\u00e1dn\u00e1 pracovi\u0161t\u011b nemohou zad\u00e1vat reklamu propaguj\u00edc\u00ed pou\u017eit\u00ed manipulovan\u00fdch kmenov\u00fdch bun\u011bk, ale nav\u00edc tuto metodu nemohou leg\u00e1ln\u011b v\u016fbec poskytovat. Musela by z\u00edskat n\u011bkterou z p\u0159esn\u011b dan\u00fdch v\u00fdjimek,&#8220; vysv\u011btluje.<\/p>\n<p>Sporn\u00e1 metoda<\/p>\n<p>Ordinace, kter\u00e9 terapii kmenov\u00fdmi bu\u0148kami nab\u00edzej\u00ed, nov\u00e9 regule rozladily. &#8222;Poskytovatel\u00e9 p\u0159in\u00e1\u0161ej\u00ed novou a nad\u011bjnou metodu zpomalen\u00ed degenerativn\u00edch zm\u011bn bez nutnosti analgetik a dal\u0161\u00edch chemick\u00fdch prepar\u00e1t\u016f. Vydan\u00e9 stanovisko jim v\u0161ak nyn\u00ed velmi komplikuje situaci. V kone\u010dn\u00e9m d\u016fsledku je tak po\u0161kozen pacient,&#8220; m\u00edn\u00ed profesor Jaroslav Mich\u00e1lek, kter\u00fd pat\u0159\u00ed k nejv\u011bt\u0161\u00edm zast\u00e1nc\u016fm terapie pomoc\u00ed kmenov\u00fdch bun\u011bk. Vlastn\u00ed tak\u00e9 firmu Cellthera, je\u017e kmenov\u00e9 bu\u0148ky zpracov\u00e1v\u00e1.<br \/>\nNa Janu Petrenko se obracej\u00ed pacienti, kte\u0159\u00ed vydali desetitis\u00edce, n\u011bkdy i statis\u00edce korun za uvedenou formu l\u00e9\u010dby kloub\u016f v priv\u00e1tn\u00edch ordinac\u00edch. Artr\u00f3za jim toti\u017e nevymizela a na operaci, hrazenou zdravotn\u00edmi poji\u0161\u0165ovnami, pak stejn\u011b museli.<\/p>\n<p>K soudu m\u00ed\u0159\u00ed prvn\u00ed \u017ealoba pacienta, jen\u017e za terapii v pra\u017esk\u00e9 Poliklinice I. P. Pavlova zaplatil 54 tis\u00edc korun, ale nezabrala mu.<br \/>\nCelkov\u00fd po\u010det pacient\u016f, kte\u0159\u00ed k\u00faru podstoupili, ani celkov\u00fd obrat v odv\u011btv\u00ed nen\u00ed zn\u00e1m. Nikdo toti\u017e tyto z\u00e1kroky neeviduje.<br \/>\nPracovi\u0161t\u011b maj\u00ed z\u00e1rove\u0148 nov\u011b zak\u00e1z\u00e1no publikovat reklamu na l\u00e9\u010dbu kmenov\u00fdmi bu\u0148kami pod pokutou a\u017e dva miliony korun. A l\u00e9kov\u00fd \u00fa\u0159ad ji\u017e za\u010dal na\u0159\u00edzen\u00ed kontrolovat.<br \/>\n&#8222;\u00dastav prov\u00e1d\u00ed rozs\u00e1hl\u00fd pr\u016fzkum internetov\u00e9ho prost\u0159ed\u00ed. V sou\u010dasn\u00e9 dob\u011b \u0161et\u0159\u00ed 15 subjekt\u016f pro mo\u017en\u00e9 poru\u0161en\u00ed z\u00e1kona o regulaci reklamy. Vzhledem k tomu, \u017ee tato \u0161et\u0159en\u00ed prob\u00edhaj\u00ed, nen\u00ed mo\u017en\u00e9 k nim uv\u00e1d\u011bt bli\u017e\u0161\u00ed informace,&#8220; \u0159ekla LN jeho mluv\u010d\u00ed Lucie \u0160ustkov\u00e1.<br \/>\nEvropsk\u00e1 l\u00e9kov\u00e1 agentura a posl\u00e9ze v z\u00e1\u0159\u00ed i \u010desk\u00fd \u00fastav pro kontrolu l\u00e9\u010div toti\u017e vydaly stanoviska, v nich\u017e kmenov\u00e9 bu\u0148ky, kter\u00e9 se pak upraven\u00e9 pou\u017e\u00edvaj\u00ed nap\u0159\u00edklad k l\u00e9\u010db\u011b kloub\u016f nebo diabetick\u00e9 nohy, ozna\u010dily za l\u00e9\u010div\u00e9 p\u0159\u00edpravky modern\u00ed terapie. A jako takov\u00e9 musej\u00ed p\u0159ed jejich b\u011b\u017enou aplikac\u00ed pacient\u016fm z\u00edskat registraci pr\u00e1v\u011b evropsk\u00e9 agentury.<br \/>\nTo znamen\u00e1, \u017ee by nejprve musely dolo\u017eit svoji bezpe\u010dnost a \u00fa\u010dinnost v klinick\u00fdch studi\u00edch. A\u017e na z\u00e1klad\u011b jejich v\u00fdsledk\u016f mohou pak b\u00fdt l\u00e9\u010diva registrov\u00e1na pro pou\u017eit\u00ed v cel\u00e9 Evropsk\u00e9 unii.<br \/>\n&#8222;P\u0159\u00edpravky k l\u00e9\u010db\u011b artr\u00f3zy \u010di kon\u010detinov\u00e9 ischemie takovou registraci nemaj\u00ed. V EU je centralizovan\u011b registrov\u00e1n jedin\u00fd l\u00e9\u010div\u00fd p\u0159\u00edpravek zalo\u017een\u00fd na kmenov\u00fdch bu\u0148k\u00e1ch, a to Holoclar, kter\u00fd slou\u017e\u00ed k l\u00e9\u010db\u011b o\u010dn\u00ed rohovky,&#8220; vysv\u011btlila \u0160ustkov\u00e1. P\u0159\u00edpravky dosud nezaregistroval ani americk\u00fd \u00da\u0159ad pro kontrolu potravin a l\u00e9\u010div (FDA).<\/p>\n<p>Spokojen\u00ed ortopedi<\/p>\n<p>Ortopedi nov\u00fd postoj \u00fa\u0159ad\u016f v\u00edtaj\u00ed. &#8222;Pacient vyd\u00e1 pen\u00edze za metodu, kter\u00e1 ani v nejmen\u0161\u00edm nen\u00ed podlo\u017een\u00e1 na sou\u010dasn\u00e9 v\u011bdeck\u00e9 ani legislativn\u00ed \u00farovni. Neexistuje jedin\u00fd \u010dl\u00e1nek v presti\u017en\u00edm ortopedick\u00e9m \u010dasopise, kter\u00fd by jasn\u011b potvrdil jej\u00ed \u00fa\u010dinnost,&#8220; zd\u016fraz\u0148uje profesor David Pokorn\u00fd.<br \/>\n\u010cesk\u00e1 spole\u010dnost pro ortopedii ji\u017e p\u0159ed \u010dasem vydala prohl\u00e1\u0161en\u00ed, \u017ee l\u00e9\u010dba artr\u00f3zy kmenov\u00fdmi bu\u0148kami za sou\u010dasn\u00e9ho v\u011bdeck\u00e9ho pozn\u00e1n\u00ed nepom\u00e1h\u00e1. Podobn\u011b se vyj\u00e1d\u0159ila i \u010cesk\u00e1 l\u00e9ka\u0159sk\u00e1 spole\u010dnost J. E. Purkyn\u011b k aplikaci kmenov\u00fdch bun\u011bk u diabetick\u00e9 nohy. &#8222;Zat\u00edm neexistuje dostate\u010dn\u00fd d\u016fkaz benefitu t\u00e9to l\u00e9\u010dby,&#8220; \u0159ekla \u010dlenka p\u0159edsednictva Debora Karetov\u00e1. Poskytovatel\u00e9 metody ale kmenov\u00e9 bu\u0148ky h\u00e1j\u00ed. &#8222;Nejde o l\u00e9\u010dbu, ale o zpomalen\u00ed degenerativn\u00edch zm\u011bn vznikaj\u00edc\u00edch kv\u016fli st\u00e1rnut\u00ed organismu. Jde o relativn\u011b novou alternativu pro pacienty, jak se zbavit analgetik a dal\u0161\u00edch chemicky p\u0159ipravovan\u00fdch l\u00e9\u010div, a tak\u00e9 jak se vyhnout chirurgick\u00e9mu z\u00e1kroku. Samoz\u0159ejm\u011b netvrd\u00edme, \u017ee na\u0161e metoda je v\u0161esp\u00e1sn\u00e1. Na ur\u010dit\u00fdch stupn\u00edch artr\u00f3zy v\u0161ak metoda vykazuje v\u00fdrazn\u00e9 pozitivn\u00ed \u00fa\u010dinky a dok\u00e1\u017ee pacient\u016fm pomoci,&#8220; tvrd\u00ed Mich\u00e1lek.<br \/>\nProfesor Pokorn\u00fd v\u0161ak nam\u00edt\u00e1, \u017ee dosud nen\u00ed ani zn\u00e1m detailn\u00ed mechanismus a osud kmenov\u00fdch bun\u011bk v kloubu. &#8222;Ka\u017ed\u00fd z n\u00e1s m\u00e1 ve sv\u00e9 kartot\u00e9ce n\u011bkolik pacient\u016f, kte\u0159\u00ed z\u00e1krok podstoupili \u2013 samoz\u0159ejm\u011b bez jak\u00e9hokoliv efektu. Mnohem hor\u0161\u00ed je, \u017ee n\u011bkte\u0159\u00ed pacienti si nechaj\u00ed tuto \u201al\u00e9\u010dbu\u2018 aplikovat, pak \u010dekaj\u00ed v bolestech dal\u0161\u00ed m\u011bs\u00edce na \u201aefekt\u2018 a pak teprve p\u0159ijdou na ortopedick\u00e9 pracovi\u0161t\u011b k \u0159e\u0161en\u00ed stavu. A pokud je kloub posti\u017een\u00fd tak, \u017ee jedinou metodou l\u00e9\u010dby je tot\u00e1ln\u00ed endoprot\u00e9za, je pacient za\u0159azen do \u010dekac\u00ed listiny nemocnice k v\u00fdkonu,&#8220; dod\u00e1v\u00e1 Pokorn\u00fd. Seznamy jsou p\u0159itom dlouh\u00e9, a pacienti se tak tr\u00e1p\u00ed je\u0161t\u011b dal\u0161\u00ed m\u011bs\u00edce.<\/p>\n<p>Jen na v\u00fdjimku<\/p>\n<p>Aplikaci kmenov\u00fdch bun\u011bk u diabetick\u00e9 nohy, kter\u00e1 m\u00e1 zabr\u00e1nit amputaci kon\u010detiny, cht\u011blo loni ministerstvo zdravotnictv\u00ed za\u0159adit na seznam hrazen\u00fdch v\u00fdkon\u016f. Poji\u0161\u0165ovny za n\u011b m\u011bly platit sto tis\u00edc korun. Po kritice odborn\u00e9 ve\u0159ejnosti i politik\u016f resort od z\u00e1m\u011bru upustil. Metoda ale nen\u00ed b\u011b\u017en\u011b roz\u0161\u00ed\u0159ena, v \u010cesku ji nab\u00edzela jen dv\u011b pracovi\u0161t\u011b \u2013 pra\u017esk\u00fd IKEM a Fakultn\u00ed nemocnice Ostrava.<br \/>\nNyn\u00ed mohou terapii kmenov\u00fdmi bu\u0148kami nab\u00edzet jen pracovi\u0161t\u011b, kter\u00e1 z\u00edskala n\u011bkter\u00fd z &#8222;pardon\u016f&#8220;. M\u016f\u017ee to b\u00fdt takzvan\u00e1 nemocni\u010dn\u00ed v\u00fdjimka, p\u0159\u00edpadn\u011b m\u016f\u017ee b\u00fdt metoda poskytov\u00e1na v r\u00e1mci specifick\u00e9ho l\u00e9\u010debn\u00e9ho programu.<br \/>\n&#8222;\u017d\u00e1dn\u00e1 nemocni\u010dn\u00ed v\u00fdjimka ud\u011blena nebyla ani neprob\u00edh\u00e1 \u017e\u00e1dn\u00fd specifick\u00fd l\u00e9\u010debn\u00fd program,&#8220; up\u0159esnila \u0160ustkov\u00e1.<br \/>\nDal\u0161\u00ed mo\u017enost\u00ed, jak terapii poskytovat, je nab\u00edzet ji v r\u00e1mci klinick\u00fdch zkou\u0161ek. Takov\u00e9 hodnocen\u00ed ale b\u011b\u017e\u00ed jen v ostravsk\u00e9 fakultn\u00ed nemocnici. Je zam\u011b\u0159en\u00e9 na l\u00e9\u010dbu diabetick\u00e9 nohy a vede jej profesor V\u00e1clav Proch\u00e1zka. V\u00fdsledky maj\u00ed b\u00fdt podle pl\u00e1nu hotovy a\u017e koncem roku 2016.<br \/>\nB\u011bhem klinick\u00fdch zkou\u0161ek jsou pacienti l\u00e9\u010den\u00ed zdarma. Z\u00e1rove\u0148 tyto metody neplat\u00ed zdravotn\u00ed poji\u0161\u0165ovny. &#8222;Tyto v\u00fdkony zat\u00edm nejsou hrazen\u00e9 z ve\u0159ejn\u00e9ho zdravotn\u00edho poji\u0161t\u011bn\u00ed,&#8220; potvrdil mluv\u010d\u00ed VZP Old\u0159ich Tich\u00fd.<br \/>\nZt\u00ed\u017eena je i l\u00e9\u010dba za p\u0159\u00edmou platbu pacientem. V \u00favahu by p\u0159ich\u00e1zela jedin\u00e1 mo\u017enost, a to speci\u00e1ln\u00ed re\u017eim pou\u017eit\u00ed neregistrovan\u00e9ho l\u00e9ku, kter\u00fd se uplat\u0148uje v krajn\u00edch p\u0159\u00edpadech, kdy nen\u00ed pro konkr\u00e9tn\u00ed onemocn\u011bn\u00ed jin\u00e1 terapie.<br \/>\n&#8222;Poskytovatel\u00e9 kmenov\u00fdch bun\u011bk by tak\u00e9 museli z\u00edskat ur\u010dit\u00fd certifik\u00e1t spr\u00e1vn\u00e9 v\u00fdrobn\u00ed praxe, co\u017e pro \u0159adu z nich nen\u00ed lehce dosa\u017eiteln\u00e9,&#8220; dopl\u0148uje l\u00e9kov\u00fd specialista Filip Vrubel.<br \/>\nPod\u00e1n\u00ed neregistrovan\u00e9ho l\u00e9ku mus\u00ed b\u00fdt nav\u00edc hl\u00e1\u0161eno na l\u00e9kov\u00fd \u00fa\u0159ad. Ten zat\u00edm \u017e\u00e1dn\u00e9 takov\u00e9 ozn\u00e1men\u00ed neeviduje. &#8222;Z\u00e1rove\u0148 mus\u00ed tato pracovi\u0161t\u011b s pacienty podepsat smlouvu, v n\u00ed\u017e bude uvedeno, \u017ee se jedn\u00e1 pr\u00e1v\u011b o neregistrovan\u00fd p\u0159\u00edpravek,&#8220; dopl\u0148uje pr\u00e1vn\u00edk Ond\u0159ej Dost\u00e1l. Pacienti musej\u00ed b\u00fdt informov\u00e1ni, \u017ee jde o neov\u011b\u0159enou experiment\u00e1ln\u00ed l\u00e9\u010dbu.<br \/>\nProbl\u00e9m s prod\u00e1v\u00e1n\u00edm neov\u011b\u0159en\u00e9 l\u00e9\u010dby kmenov\u00fdmi bu\u0148kami se net\u00fdk\u00e1 jen \u010ceska. Asi nejv\u011bt\u0161\u00ed s\u00edt\u00ed klinik, kter\u00e9 &#8222;l\u00e9\u010d\u00ed&#8220; t\u00edmto zp\u016fsobem kdeco od vypad\u00e1v\u00e1n\u00ed vlas\u016f a\u017e po chronick\u00e9, \u017eivot ohro\u017euj\u00edc\u00ed obt\u00ed\u017ee, jako je srde\u010dn\u00ed selh\u00e1n\u00ed, svalov\u00e1 dystrofie \u010di Parkinsonova choroba, disponuj\u00ed Spojen\u00e9 st\u00e1ty. V respektovan\u00e9m odborn\u00e9m \u010dasopise The New England Journal of Medicine vy\u0161el 10. z\u00e1\u0159\u00ed \u010dl\u00e1nek, popisuj\u00edc\u00ed, jak se ani FDA neda\u0159\u00ed tento byznys zastavit.<\/p>\n<p>Stop experiment\u016f s lidmi<\/p>\n<p>Pacienti p\u0159itom plat\u00ed za terapie od p\u011bti do 50 tis\u00edc dolar\u016f. &#8222;Tyto kliniky tvrd\u00ed, \u017ee jejich l\u00e9\u010dba je efektivn\u00ed, i kdy\u017e tento v\u00fdrok nen\u00ed opodstatn\u011bn\u00fd. Jejich webov\u00e9 str\u00e1nky l\u00e9\u010dbu ozna\u010duj\u00ed za experiment\u00e1ln\u00ed, p\u0159esto\u017ee \u017e\u00e1dn\u00e1 z klinik neprov\u00e1d\u00ed klinick\u00e9 zkou\u0161ky schv\u00e1len\u00e9 FDA, a zd\u016fraz\u0148uj\u00ed potenci\u00e1ln\u00ed regenera\u010dn\u00ed schopnosti kmenov\u00fdch bun\u011bk. Jejich jazyk je z\u00e1m\u011brn\u011b nep\u0159esn\u00fd a vyu\u017e\u00edv\u00e1 zranitelnosti pacient\u016f s v\u00e1\u017en\u00fdmi chorobami,&#8220; kritizuj\u00ed auto\u0159i \u010dl\u00e1nku.<br \/>\nZd\u016fraz\u0148uj\u00ed, \u017ee FDA bude muset p\u0159ijmout nov\u00e9 regule, aby ochr\u00e1nil pacienty a z\u00e1rove\u0148 zabr\u00e1nil tomuto ziskem motivovan\u00e9mu experimentov\u00e1n\u00ed s lidmi.<\/p>\n<p>MARCELA ALF\u00d6LDI \u0160PERKEROV\u00c1<br \/>\nLidov\u00e9 noviny<\/p>\n","protected":false},"excerpt":{"rendered":"<div class=\"mh-excerpt\"><p>Nov\u00e9 terapie kmenov\u00fdmi bu\u0148kami budou muset nejd\u0159\u00edv prok\u00e1zat svou \u00fa\u010dinnost<\/p>\n<\/div>","protected":false},"author":1,"featured_media":5408,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11],"tags":[],"class_list":["post-22741","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-zdravi"],"_links":{"self":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/posts\/22741","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=22741"}],"version-history":[{"count":0,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/posts\/22741\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=\/wp\/v2\/media\/5408"}],"wp:attachment":[{"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=22741"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=22741"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.invarena.cz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=22741"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}