ImmCelz® Stem Cell Component Demonstrated Efficacious in FDA Double Blind Placebo Controlled Clinical Trial of Advanced COVID-19 Patients

IMMCelz®干细胞成分在FDA对晚期COVID-19患者的双盲安慰剂对照临床试验中显示有效

2021-01-07 06:33:50 BioSpace

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Creative Medical Technology Holdings, Inc. commented today on a peer-reviewed publication from the University of Miami demonstrating that the intravenous administration of umbilical cord derived stem cells, termed "JadiCells" results in a significant survival improvement in COVID-19 patients. https://stemcellsjournals.onlinelibrary.wiley.com/doi/full/10.1002/sctm.20-0472 The Phase 1/2 double blind, placebo-controlled trial treated 12 advanced COVID-19 patients with 100 million JadiCells™ intravenously at days 0 and 3, and 12 additional patients received placebo control.  At 28 days 91% of JadiCell™ treated patients survived whereas only 42% of patients in the placebo group survived.  There were no adverse effects associated with JadiCell™ administration. "The ImmCelz® regenerative immunotherapy product is a personalized cellular therapy generated by co-culture of patient's immune cells with stem cells.  Due to the superior nature of the JadiCell™ to other cell types, under license, we exclusively use this cell type for production of ImmCelz®," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. "The data reported today strongly supports the safety and potency of the JadiCell™, which also supports the validity of ImmCelz® which is 'powered by JadiCell™.' It should be noted that neither Creative Medical Technology Holdings nor ImmCelz® were involved in the University of Miami trial, and that Creative Medical Technology Holdings is not pursuing COVID-19 treatments at this time," Mr. Warbington said further. The ImmCelz® cell therapy product has demonstrated efficacy in animal models of stroke, heart failure, autoimmunity, and liver failure.  While the majority of companies utilize stem cell administration for therapeutic intent, ImmCelz® uses stem cells to "reprogram" patient immune cells, a process which endows the immune cells with ability to regenerate injured organs. "It has been my pleasure to work with Timothy Warbington and his scientific team in creating a new class of cellular therapies that combines regenerative medicine with immunotherapy," said Amit Patel, MD, MS, inventor of the JadiCell™ and co-inventor of ImmCelz®.  "The speed, precision and innovation that drives the team at Creative Medical Technology Holdings is unparalleled and I look forward to clinical translation of ImmCelz®, which is the subject of an Investigational New Drug Application that is being currently compiled." About Creative Medical Technology Holdings Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in regenerative stem cell technology in the fields of Immunotherapy, urology, neurology and orthopedics, and is quoted on the OTC Markets under the symbol CELZ. For further information about the company, please visit www.creativemedicaltechnology.com.  Forward Looking Statements OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website at www.sec.gov. Creativemedicaltechnology.com www.StemSpine.com www.Caverstem.com www.Femcelz.com multimedia:http://www.prnewswire.com/news-releases/immcelz-stem-cell-component-demonstrated-efficacious-in-fda-double-blind-placebo-controlled-clinical-trial-of-advanced-covid-19-patients-301201752.html
Creative Medical Technology Holdings,Inc.今天对迈阿密大学的一份经同行评审的出版物发表了评论,该出版物证明静脉给药脐带来源的干细胞(称为“Jadicells”)可显著提高COVID-19患者的存活率。 https://stemcellsjournals.onlinelibrary.wiley.com/doi/full/10.1002/sctm.20-0472 1/2期双盲,安慰剂对照试验在第0天和第3天静脉注射1亿Jadicells™治疗12例晚期COVID-19患者,另外12例患者接受安慰剂对照。28天时,接受Jadicell™治疗的患者有91%存活,而安慰剂组仅有42%存活。Jadicell™给药未出现不良反应。 Creative Medical Technology Holdings总裁兼首席执行官Timothy Warbington说:“ImmCelz®再生免疫疗法产品是一种个性化的细胞疗法,由患者的免疫细胞与干细胞共同培养产生。由于JadicEll™优于其他细胞类型,根据许可,我们专门使用这种细胞类型生产ImmCelz®。”“今天报道的数据有力地支持了jadicell™的安全性和有效性,这也支持了immcelz®的有效性,immcelz®是由jadicell™提供动力的。应该注意的是,Creative Medical Technology Holdings和immcelz®都没有参与迈阿密大学的试验,而且Creative Medical Technology Holdings目前并不追求COVID-19的治疗,”Warbington先生进一步说道。 ImmCelz®细胞治疗产品已在中风,心力衰竭,自身免疫和肝功能衰竭的动物模型中显示出疗效。大多数公司利用干细胞给药进行治疗,而ImmCelz®则利用干细胞对患者免疫细胞进行“重编程”,这一过程赋予免疫细胞再生受损器官的能力。 Jadicell™的发明者和Immcelz®的共同发明者Amit Patel医学博士,医学硕士说:“我很高兴与Timothy Warbington及其科学团队合作,创建一种将再生医学与免疫疗法相结合的新型细胞疗法。驱动Creative Medical Technology Holdings公司团队的速度,精度和创新是无与伦比的,我期待着ImmCelz®的临床翻译,它是目前正在编写的一项研究性新药申请的主题。“ 关于创新医疗技术控股公司 Creative Medical Technology Holdings,Inc.是一家商业阶段生物技术公司,专门从事免疫疗法,泌尿学,神经学和矫形学领域的再生干细胞技术,并在场外市场以CELZ代码报价。有关该公司的更多信息,请访问www.creativemedicaltechnology.com。 前瞻性陈述 OTC市场部没有审查本发布的充分性或准确性,也不对此承担责任。本新闻稿可能包含前瞻性陈述,包括但不限于有关即将进行的临床试验和实验室结果的时间和内容,营销努力,资金等的评论。前瞻性陈述涉及未来事件和条件,因此涉及内在风险和不确定性。实际结果可能与这些报表中目前预期的结果大不相同。见Creative Medical Technology Holdings,Inc.向证券交易委员会提交的定期报告和其他报告,可查阅委员会网站www.sec.gov。 creativeMedicalTechnology.com www.stemspine.com www.caverstem.com www.femcelz.com 多媒体:http://www.prnewswire.com/news-releases/immcelz-stem-cell-component-demonstrated-efficacious-in-FDA-double-blind-placebo-controlled-clinical-trial-of-advanced-covid-19-patients-301201752.html

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