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American CryoStem Completes Clinical Protocol Design for Long COVID Study

American CryoStem Completes Clinical Protocol Design for Long COVID Study

American CryoStem 完成了长期 COVID 研究的临床方案设计
Accesswire ·  2021/11/30 06:06

EATONTOWN, NJ / ACCESSWIRE / November 30, 2021 / American CryoStem Corporation (OTC PINK:CRYO), a leading clinical-stage biotechnology developer of adipose-derived stem cell therapies today announced completion of its Phase I clinical protocol design for the treatment of Long COVID. American CryoStem anticipates that the protocol will be filed as an FDA Phase I IND in cooperation with a major US medical center in Q-1, 2022.

新泽西州伊顿敦/ACCESSWIRE/2021 年 11 月 30 日/ 美国 CryoStem 公司 (OTC PINK: CRYO),脂肪衍生干细胞疗法的领先临床阶段生物技术开发商,今天宣布其治疗Long COVID的I期临床方案设计已经完成。American CryoStem预计,该协议将在2022年第一季度与美国一家大型医疗中心合作,作为美国食品药品管理局第一阶段的IND提交。

Medical complications of Long Covid patients include reports of the development of new or recurrent symptoms that affect several distinct physiologic systems including but not limited to neurological, respiratory, gastrointestinal, cardiac, endocrine, dermatological, hepatic, and renal that persist for many months following resolution of the acute infection and associated illness.

Long Covid患者的医疗并发症包括有报告称出现新的或反复出现的症状,这些症状会影响几个不同的生理系统,包括但不限于神经、呼吸、胃肠、心脏、内分泌、皮肤病、肝脏和肾脏,这些症状在急性感染和相关疾病消失后会持续数月。

According to the Centers for Disease Control and Prevention, "post-COVID conditions can be considered a lack of return to a usual state of health following acute COVID-19 illness." In the US, following COVID recovery, it is reported that up to 30% of those afflicted, diagnosed, or treated for COVID-19 have continuing symptoms and medical complications following recovery from the acute illness. A recently published study of patients diagnosed with COVID-19 suggest that the global incidence of Long Covid complications may be much higher. See: Incidence, co-occurrence, and evolution of long-COVID features: A 6-month retrospective cohort study of 273,618 survivors of COVID-19

根据美国疾病控制与预防中心的说法,“COVID后的病症可以被视为急性 COVID-19 疾病后无法恢复到正常的健康状态。”在美国,据报道,在 COVID 康复后,高达 30% 的 COVID-19 患者、被诊断出或接受治疗的人在从急性疾病中恢复过来后仍有持续的症状和医疗并发症。最近发表的一项针对被诊断为 COVID-19 的患者的研究表明,全球冠状病毒肺炎并发症的发病率可能要高得多。参见:长期 COVID 特征的发病率、共存和演变:一项针对 273,618 名 COVID-19 幸存者的为期 6 个月的回顾性队列研究

The Company continues to collaborate with its scientific and clinical teams to file the Investigational New Drug (IND) application with its institutional partner to facilitate the timely initiation of its Phase I clinical testing. American CryoStem is focused on developing effective stem cell therapies to treat and ameliorate Long COVID. The upcoming Phase I clinical trial will assess CryoStem's proprietary ATCell® therapy for safety and tolerability in the setting of Long COVID with the goal of rapidly developing a safe and effective therapy for Long COVID, where none currently exists.

该公司继续与其科学和临床团队合作,向其机构合作伙伴提交研究性新药(IND)申请,以促进其I期临床试验的及时启动。American CryoStem专注于开发有效的干细胞疗法,以治疗和改善Long COVID-19。即将进行的 I 期临床试验将评估 CryoStem 专有的 atCell® 在Long COVID环境中进行安全性和耐受性的疗法,目标是快速开发一种安全有效的治疗长COVID的治疗方法,而目前尚不存在这种疗法。

For further information please visit: www.americancryostem.com, send email to: info@americancryostem.com or contact the Company directly at 732-747-1007.

欲了解更多信息,请访问:www.americancryostem.com,发送电子邮件至:info@americancryostem.com 或直接致电 732-747-1007 与公司联系。

About American CryoStem Corporation: (CRYO), founded in 2008, is a clinical-stage biotechnology Company, developing and delivering autologous mesenchymal stem cell (MSC) therapies leveraging its mCMC (mesenchymal, Chemistry, Manufacturing, and Controls) patented platform to collect-process-store-return to point of care genetically matched personalized therapy. The Platform supports a growing pipeline of biologic therapies, products, processes, and international licensing opportunities. The Company's platform provides patients the opportunity for a single adipose-tissue (fat) harvest to be processed, stored, and ultimately used for cosmetic fat transfer purposes or for immediate or future processing to MSCs. The platform is configured to produce large quantities of genetically matched mesenchymal stem cells (ATCell®) for future individual or successive multiple treatments as needed, "on demand". The Company has strategically positioned its cellular therapy product pipeline to; attract collaborative partners, accelerate creation of new treatment applications, and improve manufacturing processes and testing methods. New collaborative efforts are designed to result in additional intellectual property and targeted commercial products to ultimately produce significant future revenue. CRYO is targeting topical applications and untreatable and incurable neurologic diseases, disorders, and conditions that have a large unmet medical need and US FDA Orphan drug designation. The Company operates a cGMP compliant, FDA registered laboratory, located in Monmouth Junction, New Jersey, USA, and licensed laboratory operations in Hong Kong, China, and Thailand.

关于美国 CryoStem 公司: (CRYO) 成立于2008年,是一家处于临床阶段的生物技术公司,利用其mcMC(间充质、化学、制造和控制)专利平台开发和提供自体间充质干细胞(MSC)疗法,收集过程-存储-返回基因匹配的个性化疗法。该平台支持不断增长的生物疗法、产品、工艺和国际许可机会。该公司的平台为患者提供了对单一脂肪组织(脂肪)进行加工、储存并最终用于美容脂肪转移目的或立即或将来加工到间充质干细胞的机会。该平台配置为生产大量基因匹配的间充质干细胞 (atCell)®)用于将来根据需要进行单独或连续的多重治疗,“按需”。该公司已将其细胞疗法产品线进行战略定位,以:吸引合作伙伴,加快新疗法应用的创建,并改善制造流程和测试方法。新的合作努力旨在带来更多的知识产权和有针对性的商业产品,从而最终产生可观的未来收入。CRYO的目标是局部应用以及无法治愈和无法治愈的神经系统疾病、疾病和有大量未得到满足的医疗需求并被美国食品药品管理局认定为孤儿药的疾病。该公司在美国新泽西州蒙茅斯交界处设有符合cGMP、FDA注册的实验室,并在香港、中国和泰国运营持牌实验室。

SOURCE: American CryoStem Corporation

来源: 美国 CryoStem 公司


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