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American CryoStem Completes Clinical Protocol Design for Long COVID Study

American CryoStem Completes Clinical Protocol Design for Long COVID Study

美國CryoStem公司完成長期COVID研究的臨牀方案設計
Accesswire ·  2021/11/30 14:06

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.

新澤西州伊頓鎮/ACCESSWIRE/2021年11月30日/ 美國CryoStem公司OTC PINK:CRYO)是一家領先的脂肪幹細胞療法臨牀階段生物技術開發商,該公司今天宣佈完成其治療Long CoVID的I期臨牀方案設計。美國CryoStem公司預計,該協議將於2022年第一季度作為FDA第一階段IND與美國一家主要醫療中心合作提交。

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出現新的或復發的症狀的報道,這些症狀影響到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、皮膚科、肝臟和腎臟,這些症狀在急性感染和相關疾病緩解後持續數月。

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

根據疾病控制和預防中心的説法,“COVID後的情況可以被認為是急性新冠肺炎疾病後沒有恢復到正常的健康狀態。”在美國,據報道,在COVID康復後,高達30%的新冠肺炎患者在急性疾病康復後仍有持續的症狀和醫療併發症。最近發表的一項對被診斷為新冠肺炎的患者的研究表明,全球長Covid併發症的發生率可能要高得多。參見:長期COVID特徵的發生率、共發生和演變:一項對273,618名新冠肺炎倖存者進行的為期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牀團隊合作,與其機構合作伙伴提交研究新藥(IND)申請,以促進其第一階段臨牀試驗的及時啟動。美國CryoStem專注於開發有效的幹細胞療法來治療和改善長期COVID。即將到來的I期臨牀試驗將評估CryoStem公司專有的ATCell®長期COVID治療的安全性和耐受性,目標是迅速開發一種安全有效的治療Long COVID的方法,目前尚無治療方法。

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

欲瞭解更多信息,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,是一家臨牀階段的生物技術公司,利用其MCMC(間充質、化學、製造和控制)專利平臺,開發和提供自體間充質幹細胞(MSC)療法,以收集-處理-存儲-返回護理點基因匹配的個性化治療。該平臺支持越來越多的生物療法、產品、流程和國際許可機會。該公司的平臺為患者提供了對單個脂肪組織(FAT)進行加工、儲存並最終用於美容脂肪轉移的機會,或者用於立即或將來對MSCs進行加工。該平臺被配置為生產大量基因匹配的間充質幹細胞(ATCell®)對於將來需要的個別或連續多次治療,“按需”。該公司對其細胞治療產品線進行了戰略定位,以吸引合作伙伴,加快開發新的治療應用,並改進製造工藝和測試方法。新的合作努力旨在產生額外的知識產權和有針對性的商業產品,最終產生可觀的未來收入。CRYO的目標是局部應用,以及無法治療和無法治癒的神經疾病、紊亂和有大量未得到滿足的醫療需求和美國FDA孤兒藥物指定的情況。該公司在美國新澤西州蒙茅斯交界處設有符合cGMP的FDA註冊實驗室,並在中國香港特區和泰國經營有執照的實驗室業務。

SOURCE: American CryoStem Corporation

資料來源:美國CryoStem公司


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