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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 完成了長期 COVID 研究的臨床方案設計
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.

新澤西州伊頓敦/ACCESSWIRE/2021 年 11 月 30 日/ 美國 CryoStem 公司 (OTC PINK: CRYO),脂肪衍生幹細胞療法的領先臨床階段生物技術開發商,今天宣佈其治療Long COVID的I期臨床方案設計已經完成。American CryoStem預計,該協議將在2022年第一季度與美國一家大型醫療中心合作,作爲美國食品藥品管理局第一階段的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患者的醫療併發症包括有報告稱出現新的或反覆出現的症狀,這些症狀會影響幾個不同的生理系統,包括但不限於神經、呼吸、胃腸、心臟、內分泌、皮膚病、肝臟和腎臟,這些症狀在急性感染和相關疾病消失後會持續數月。

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

根據美國疾病控制與預防中心的說法,“COVID後的病症可以被視爲急性 COVID-19 疾病後無法恢復到正常的健康狀態。”在美國,據報道,在 COVID 康復後,高達 30% 的 COVID-19 患者、被診斷出或接受治療的人在從急性疾病中恢復過來後仍有持續的症狀和醫療併發症。最近發表的一項針對被診斷爲 COVID-19 的患者的研究表明,全球冠狀病毒肺炎併發症的發病率可能要高得多。參見:長期 COVID 特徵的發病率、共存和演變:一項針對 273,618 名 COVID-19 倖存者的爲期 6 個月的回顧性隊列研究

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.

該公司繼續與其科學和臨床團隊合作,向其機構合作伙伴提交研究性新藥(IND)申請,以促進其I期臨床試驗的及時啓動。American CryoStem專注於開發有效的幹細胞療法,以治療和改善Long COVID-19。即將進行的 I 期臨床試驗將評估 CryoStem 專有的 atCell® 在Long COVID環境中進行安全性和耐受性的療法,目標是快速開發一種安全有效的治療長COVID的治療方法,而目前尚不存在這種療法。

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,請訪問:www.americancryostem.com,發送電子郵件至:info@americancryostem.com 或直接致電 732-747-1007 與公司聯繫。

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.

關於美國 CryoStem 公司: (CRYO) 成立於2008年,是一家處於臨床階段的生物技術公司,利用其mcMC(間充質、化學、製造和控制)專利平台開發和提供自體間充質幹細胞(MSC)療法,收集過程-存儲-返回基因匹配的個性化療法。該平台支持不斷增長的生物療法、產品、工藝和國際許可機會。該公司的平台爲患者提供了對單一脂肪組織(脂肪)進行加工、儲存並最終用於美容脂肪轉移目的或立即或將來加工到間充質幹細胞的機會。該平台配置爲生產大量基因匹配的間充質幹細胞 (atCell)®)用於將來根據需要進行單獨或連續的多重治療,“按需”。該公司已將其細胞療法產品線進行戰略定位,以:吸引合作伙伴,加快新療法應用的創建,並改善製造流程和測試方法。新的合作努力旨在帶來更多的知識產權和有針對性的商業產品,從而最終產生可觀的未來收入。CRYO的目標是局部應用以及無法治癒和無法治癒的神經系統疾病、疾病和有大量未得到滿足的醫療需求並被美國食品藥品管理局認定爲孤兒藥的疾病。該公司在美國新澤西州蒙茅斯交界處設有符合cGMP、FDA註冊的實驗室,並在香港、中國和泰國運營持牌實驗室。

SOURCE: American CryoStem Corporation

來源: 美國 CryoStem 公司


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