{"id":1065019,"date":"2012-05-27T15:51:24","date_gmt":"2012-05-27T15:51:24","guid":{"rendered":"http:\/\/www.longevitymedicine.tv\/industry-sponsored-cardiovascular-cell-therapies-some-metrics\/"},"modified":"2024-08-18T11:08:43","modified_gmt":"2024-08-18T15:08:43","slug":"industry-sponsored-cardiovascular-cell-therapies-some-metrics","status":"publish","type":"post","link":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/regenerative-medicine\/industry-sponsored-cardiovascular-cell-therapies-some-metrics.php","title":{"rendered":"Industry-sponsored cardiovascular cell therapies. Some metrics."},"content":{"rendered":"<p><a href=\"http:\/\/twitter.com\/share\">Tweet<\/a><br><span><br><\/span><br><span>Cell therapies for cardiovascular-related conditions is a closely watched, much studied, oft-discussed, and hotly contested segment of the cell therapy industry.<\/span><br><span><br><\/span><br><span>The data to-date are admittedly confusing. &nbsp;From a clinical perspective, the studies for which we have data have been relatively small involving a mish-mash of indications, endpoints, eligibility criterion, methods and\/or route of administration, as well as the&nbsp;<\/span><span>time of administration relative to event or disease&nbsp;progression.<\/span><br><span><br><\/span><br><span>Further compounding any interpretation of the data, from a technical perspective, is the fact the products have been widely varied in terms of being autologous vs allogeneic, expanded and not, genetically modified and not, from a plethora of different sources, and utilizing a wide variety of cell types from skelatal myoblasts, cardiomyocytes, mesenchymal stromal cells, mononuclear cells, etc.&nbsp;<\/span><br><span><br><\/span><br><span>All this makes it extremely difficult to draw any conclusions with respect to what's working and what's not. &nbsp;We will not attempt to do so.<\/span><br><span><br><\/span><br><span>All we do below is attempt to give a snapshot of the industry-sponsored cell therapy trials currently ongoing for cardiovascular-related conditions. &nbsp;So here it is:<\/span><br><span><br><\/span><br><span><b>Commercial<\/b>:<\/span><br><span><a href=\"http:\/\/www.pharmicell.com\/\" target=\"_blank\" rel=\"noopener\">Pharmicell<\/a>'s&nbsp;<a href=\"http:\/\/www.pharmicell.com\/eng\/2_3.html\" target=\"_blank\" rel=\"noopener\">Heartcelligram<\/a>&nbsp;is the&nbsp;<\/span><span>only cell therapy to have received regulatory approval for commercial distribution for the treatment of a cardiac-related indication. &nbsp;Heartcelligram is an autologous cell therapy approved in 2011 by the&nbsp;<a href=\"http:\/\/www.kfda.go.kr\/eng\" target=\"_blank\" rel=\"noopener\">Korean Food and Drug Administration<\/a>&nbsp;(KFDA) for the treatment of Acute Mycardial Infarction (AMI). &nbsp;The&nbsp;<a href=\"http:\/\/www.nature.com\/nbt\/journal\/v29\/n10\/full\/nbt1011-857b.html\" target=\"_blank\" rel=\"noopener\">price is reportedly $19,000 and the trial data behind the approval has not yet been published in a peer-reviewed journal<\/a>.<\/span><br><span><br><\/span><br><b>Phase III or II\/III<\/b><span>:<\/span><br><span>There are currently only 3 active and recruiting cardiac-related, industry-sponsored cell therapy trials. &nbsp;Interestingly they all involve autologous products, two involve devices, two involve centralized manufacturing, two involve bone marrow cells as a source, two are only in European clinical sites, and two are targeting ischemic-related conditions.<\/span><\/p><ul><li><span>Baxter Therapeutics'&nbsp;Auto-CD34+ cells<\/span><\/li><ul><li><span><a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01508910?term=NCT01508910&amp;rank=1\" target=\"_blank\" rel=\"noopener\">phase III trial actively recruiting<\/a><\/span><\/li><ul><li><span>Indication: &nbsp;refractory angina and chronic myocardial ischemia<\/span><\/li><li><span>Estimated enrollment: &nbsp;444<\/span><\/li><li><span>Estimated primary completion: June 2016&nbsp;<\/span><\/li><\/ul><\/ul><li><span>Cytori<\/span><\/li><ul><li><span><a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT01216995?term=NCT01216995&amp;rank=1\" target=\"_blank\" rel=\"noopener\">phase II\/III trial actively recruiting<\/a><\/span><\/li><li><span>Indication:&nbsp;ST-elevation acute myocardial infarction<\/span><\/li><li><span>Estimated enrollment: 360<\/span><\/li><li><span>Estimated primary completion: July 2014<\/span><\/li><\/ul><\/ul><ul><li><span>Miltenyi Biotec<\/span><\/li><ul><li><span><a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT00950274?term=NCT00950274&amp;rank=1\" target=\"_blank\" rel=\"noopener\">phase III trial actively recruiting<\/a><\/span><\/li><li><span>Indication: myocardial ischemia or coronary artery disease<\/span><\/li><li><span>Estimated enrollment: 142<\/span><\/li><li><span>Estimated primary completion: July 2012<\/span><\/li><\/ul><\/ul><div><span>Two companies warrant particular mention at this stage as they appear to be in transition between phases II and III.<\/span><\/div><div><span><br><\/span><\/div><div><span><a href=\"http:\/\/www.c3bs.com\/\" target=\"_blank\" rel=\"noopener\">Cardio3 Biosciences<\/a>&nbsp;initially designed a trial of their autologous C-Cure in h<\/span><span>eart failure secondary to ischemic cardiomyopathy to be a phase II\/III trial enrolling 240 patients.<\/span><span>&nbsp; While the trial began in late 2008 and is still registered as&nbsp;<\/span><a href=\"http:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT00810238?term=NCT00810238&amp;rank=1\" target=\"_blank\" rel=\"noopener\">active but no longer recruiting<\/a>&nbsp;<span>on&nbsp;<a href=\"http:\/\/clinicaltrials.gov\/\">ClinicalTrials.gov<\/a>&nbsp;the entry has not been updated for almost a year. &nbsp;<\/span><\/div><div><span><br><\/span><\/div><div><span>In 2010 the company announced that after enrolling 45 patients - of which 21 were in the treatment arm (24 in the control arm) - they decided to close the study to future enrollment and prepare for a phase III trial. &nbsp;This decision was reportedly based on \"very encouraging data\".&nbsp;<\/span><\/div><div><span><br><\/span><\/div><div><span>Dr. Christian Homsy, CEO of Cardio3 BioSciences provided the following guidance: &ldquo;<i>The highly promising data we report&nbsp;<\/i><\/span><i><span>today build on the favourable safety profile we have observed through this Phase II trial and&nbsp;<\/span><span>documents in patients our belief that we have with &nbsp;C-Cure a product candidate with the&nbsp;<\/span><span>potential to make a real difference in the treatment of heart failure...&nbsp;<\/span><span>As noted in the company&rsquo;s press release of 29 June 2010, with the Phase II stage completed&nbsp;<\/span><span>and to allow for potential modifications to the trial protocol, Cardio3 BioSciences has not&nbsp;<\/span><span>proceeded to Phase III recruitment into the trial but has continued to gather all data for the&nbsp;<\/span><span>six month analysis.&nbsp;<\/span><span>Through the Phase II trial, we gained significant &nbsp;experience in working with a highly&nbsp;<\/span><span>innovative stem cell therapy in a clinical setting, and we are using this acquired knowledge in&nbsp;<\/span><\/i><span><i>the design of our planned Phase III programme.<\/i>\" &nbsp;The phase III trial of C-Cure is expected to commence in the second half of 2012.<\/span><br><span><br><\/span><span><a href=\"http:\/\/www.mesoblast.com\/\" target=\"_blank\" rel=\"noopener\">Mesoblast<\/a>&nbsp;has also announced with its strategic partner,&nbsp;<a href=\"http:\/\/www.tevapharm.com\/\" target=\"_blank\" rel=\"noopener\">Teva<\/a>, that they are proceeding with&nbsp;<a href=\"http:\/\/www.mesoblast.com\/download\/376\/\" target=\"_blank\" rel=\"noopener\">plans to conduct a phase III study<\/a>&nbsp;of its allogeneic cell therapy product, Revascor, in chronic heart failure. &nbsp;Most anticipate this clinical trial application to be filed sometime in late 2012.<\/span><\/div><div><span><br><\/span><br><b>Phase I or II<\/b><span>:<\/span><br><span>There are over 20 active, industry-sponsored earlier-stage trials (phase I, I\/II or II) for cardiovascular-related conditions. &nbsp;At least 5 of these are expected to have clinical readouts this year. &nbsp;&nbsp;<\/span><\/div><p><span><\/span><\/p><div><span><br><\/span><br><span>Hope this is useful.<\/span><\/div><div><div><span><br><\/span><\/div><div><span>--<\/span><\/div><div><span><br><\/span><\/div><div><span>This post has been brought to you by your friends at&nbsp;<\/span><span><a href=\"http:\/\/www.celltherapygroup.com\/\" target=\"_blank\" rel=\"noopener\">CTG<\/a>. &nbsp;<\/span><span>All cell therapy. All the time.&nbsp;<\/span><span>\ud83d\ude42<\/span><span>&nbsp;<\/span><span>&nbsp;<\/span><\/div><div><span><br><\/span><\/div><p><span>-- Lee&nbsp;<a href=\"https:\/\/twitter.com\/#!\/celltherapy\" target=\"_blank\" rel=\"noopener\">@celltherapy<\/a><\/span><\/p><p><span>p.s. &nbsp;As always we welcome your feedback, comments, and corrections. &nbsp;<\/span><\/p><\/div><div><\/div><p><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><span><br><\/span><br><br class=\"Apple-interchange-newline\"><\/p><div><a href=\"http:\/\/www.celltherapyblog.com\" rel=\"nofollow\">http:\/\/www.celltherapyblog.com<\/a> hosted by <a href=\"http:\/\/www.celltherapygroup.com\" rel=\"nofollow\">http:\/\/www.celltherapygroup.com<\/a><img loading=\"lazy\" decoding=\"async\" width=\"1\" height=\"1\" src=\"http:\/\/www.longevitymedicine.tv\/wp-content\/plugins\/wp-o-matic\/cache\/b15d9_5251734313338196429-5237986622289605414?l=celltherapyblog.blogspot.com\" alt=\"\" style=\"padding-left:10px; padding-right: 10px;\"><\/div><p>Source:<br><a href=\"http:\/\/feeds.feedburner.com\/CellTherapyBlog\">http:\/\/feeds.feedburner.com\/CellTherapyBlog<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>TweetCell therapies for cardiovascular-related conditions is a closely watched, much studied, oft-discussed, and hotly contested segment of the cell therapy industry.The data to-date are admittedly confusing. &nbsp;From a clinical perspective, the studies for which we have data have been relatively &hellip; <a href=\"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/regenerative-medicine\/industry-sponsored-cardiovascular-cell-therapies-some-metrics.php\">Continue reading <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n","protected":false},"author":64,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"limit_modified_date":"","last_modified_date":"","_lmt_disableupdate":"","_lmt_disable":"","footnotes":""},"categories":[1246880],"tags":[],"class_list":["post-1065019","post","type-post","status-publish","format-standard","hentry","category-regenerative-medicine"],"modified_by":null,"_links":{"self":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/1065019"}],"collection":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/users\/64"}],"replies":[{"embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/comments?post=1065019"}],"version-history":[{"count":0,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/posts\/1065019\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/media?parent=1065019"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/categories?post=1065019"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.euvolution.com\/futurist-transhuman-news-blog\/wp-json\/wp\/v2\/tags?post=1065019"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}