Company reaches next clinical trial milestone for the intramuscular treatment of Chronic Lower Back Pain with the first novel allogenic cellular therapy in the United States

该公司在美国首次新型同种异体细胞疗法中达到了肌肉注射治疗慢性腰痛的下一个临床试验里程碑

PHOENIX, Oct. 10, 2023 /PRNewswire/ -- Creative Medical Technology Holdings, Inc. ('Creative Medical Technology' or the 'Company') (NASDAQ: CELZ), a biotechnology company focused on a regenerative approach to immunotherapy, endocrinology, urology, gynecology, and orthopedics, today announced that it has received Institutional Review Board ('IRB') approval to proceed with its clinical trial for the treatment of chronic lower back pain with its StemSpine® procedure using AlloStem™ ('CELZ-201-DDT') cell therapy..

PHOENIX，2023年10月10日/PRNewswire/-Creative Medical Technology Holdings，Inc。（'Creative Medical Technology'或'Company'）（纳斯达克：CELZ），一家专注于免疫疗法，内分泌学再生方法的生物技术公司，泌尿科，妇科和骨科，今天宣布，它已获得机构审查委员会（'IRB'）批准，使用AlloStem®程序进行治疗慢性腰痛的临床试验™ （'CELZ-201-DDT'）细胞疗法。。

The receipt of IRB approval is a necessary step that will allow Creative Medical Technology to move forward with recruitment of its recently FDA approved Phase 1 /2 randomized, double blind, placebo controlled clinical trial to evaluate the safety, efficacy, and tolerability of CELZ-201-DDT.  The study will enroll 30 individuals suffering from chronic lower back pain caused by Degenerative Disc Disease..

收到IRB批准是一个必要的步骤，这将使创意医疗技术能够推进其最近FDA批准的1/2期随机，双盲，安慰剂对照临床试验的招募，以评估其安全性，有效性和耐受性。CELZ-201-DDT。该研究将招募30名患有由退行性椎间盘疾病引起的慢性下背痛的个体。。

An IRB is an FDA-registered consortium that has been formally designated to review and monitor biomedical research involving human subjects. IRB approval is a critical and necessary prerequisite to commencing human clinical trials and serves an important role in the protection of the rights and welfare of human research subjects..

IRB是FDA注册的财团，已正式指定审查和监视涉及人类受试者的生物医学研究。IRB的批准是开始人体临床试验的关键和必要的先决条件，并且在保护人体研究对象的权利和福利方面发挥着重要作用。。

'We are pleased to announce the expeditious receipt of this vital next step in commencing the clinical trial for CELZ-201-DDT,' said Timothy Warbington, CEO of Creative Medical Technology. 'Studies show that 8% of all adults in the United States, approximately 16 million people, experience chronic lower back pain.

“我们很高兴宣布尽快接受这一重要的下一步开始CELZ-201-DDT临床试验，”创意医疗技术首席执行官蒂莫西·沃宾顿说研究表明，美国所有成年人中有8%（约1600万人）患有慢性腰痛。

The economic impact is also significant, as a report from the National Library of Medicine estimates that $200 billion is spent annually on the management of back pain. In addition to limiting their daily activities and negatively impacting their quality of life, many of those suffering rely on opioids as the standard of care which carry their own side effects, not the least of which is addiction.

经济影响也很显着，国家医学图书馆的一份报告估计，每年用于治疗背痛的费用为2000亿美元。除了限制他们的日常活动并对他们的生活质量产生负面影响之外，许多遭受痛苦的人依靠阿片类药物作为护理标准，这些护理标准带有自己的副作用，其中最重要的是成瘾。

We are hopeful that the outcome of this clinical trial will validate the efficacy, safety, and endurance of CELZ-201-DDT as a non-surgical treatment option for chronic lower back pain.'.

我们希望这项临床试验的结果将验证CELZ-201-DDT作为慢性腰痛的非手术治疗选择的有效性，安全性和持久性。

About CELZ-201-DDT

关于CELZ-201-DDT

CELZ-201-DDT is a patented procedure that utilizes an 'off the shelf, ready-to-use' universal and proprietary allogenic (donor) cell line developed by the Company and trademarked as AlloStem™. Using an ultrasound guided, non-surgical procedure, AlloStem™ is injected in areas surrounding the diseased disc(s), thereby potentially repairing, remodeling, and improving the blood supply around the disc and lower back area, without exposing the patient to radiation as with other cell-based procedures.

CELZ-201-DDT是一项专利程序，利用该公司开发的“现成，即用型”通用和专有同种异体（供体）细胞系，商标为AlloStem™. 使用超声引导，非手术程序，AlloStem™ 在患病椎间盘周围的区域注射is，从而潜在地修复，重塑和改善椎间盘和下背部区域周围的血液供应，而不像其他基于细胞的程序那样使患者暴露于辐射。

CELZ-201-DDT distinguishes itself by using a unique immunomodulatory formula derived from allogeneic perinatal cells, which in preliminary studies have shown potential for tissue repair and changing cytokine profiles..

CELZ-201-DDT通过使用来自同种异体围产期细胞的独特免疫调节配方来区分自身，初步研究显示其具有组织修复和改变细胞因子谱的潜力。。

Details on the clinical trial may be found here: NCT06053242.

有关临床试验的详细信息，请访问：NCT06053242。

About Creative Medical Technology HoldingsCreative Medical Technology Holdings, Inc. is a biotechnology company dedicated to the advancement of identifying and translating novel immediately deployable FDA registered biological therapeutics in the fields of immunotherapy, endocrinology, urology, gynecology and orthopedics and is traded on NASDAQ under the ticker symbol CELZ.

关于创意医疗技术HoldingCreative Medical Technology Holdings，Inc。是一家生物技术公司，致力于推进在免疫治疗，内分泌，泌尿外科，妇科和骨科领域识别和翻译新型可立即部署的FDA注册生物治疗药物，并在纳斯达克进行交易。勾号CELZ。

For further information about the Company, please visit www.creativemedicaltechnology.com..

有关该公司的更多信息，请访问www.creativemedicaltechnology.com。。

Special Note Regarding Forward Looking StatementsNASDAQ 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.

关于前瞻性声明的特别说明SNASDAQ市场尚未经过审核，也不承担此版本的充分性或准确性的责任。本新闻稿可能包含前瞻性声明，包括但不限于对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。

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..

前瞻性声明涉及未来的事件和条件，因此涉及固有的风险和不确定性。实际结果可能与本声明中目前预期的结果大不相同。请参阅Creative Medical Technology Holdings，Inc.与证券交易委员会提交的定期报告和其他报告，这些报告可在委员会网站www.sec.gov上获得。。

SOURCE Creative Medical Technology Holdings, Inc.

SOURCE Creative Medical Technology Holdings，Inc。