American CryoStem Announces Completion of Patient Recruitment for its Post-Concussion Syndrome (PCS) ATCELL(TM) Phase I Clinical Trial
American CryoStem Announces Completion of Patient Recruitment for its Post-Concussion Syndrome (PCS) ATCELL(TM) Phase I Clinical Trial
EATONTOWN, NJ / ACCESSWIRE / December 22, 2021 / American CryoStem Corporation (OTC PINK:CRYO) a clinical-stage biotechnology company, global licensor, and a pioneer in autologous cellular processing and therapies announced today that its clinical study team has completed recruiting subjects for its Investigational New Drug (IND) Phase I Clinical Trial for Post-concussion syndrome. The singe site, multi-dosage blinded study is being conducted by BioSolutions Clinical Research Center, LLC.
新澤西州伊頓鎮/ACCESSWIRE/2021年12月22日/亞洲網加利福尼亞州聖何塞10月16日電臨牀階段生物技術公司、全球許可方和自體細胞加工和療法的先驅美國CryoStem公司(場外交易代碼:CRYO)今天宣佈,其臨牀研究團隊已經完成了腦震盪後綜合徵的研究性新藥(IND)第一階段臨牀試驗的招募工作。生物解決方案臨牀研究中心正在進行這項單地點、多劑量的盲法研究。
The Principal Investigator (PI) today announced that the Study is 100% recruited; the Study team will begin administering the investigative ATCELL™ therapy treatments in January 2022. The Company's ATCELL™ (autologous mesenchymal stem cell) infusion therapy (the "Investigational New Drug") Study is titled: ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed via Intravenous Infusion for the Treatment of Post-Concussion Syndrome (PCS) in Retired Military and Athletes. The Study is listed on ClinicalTrials.gov under the identifier NCT04744051.
首席調查員(PI)今天宣佈,這項研究已經100%招募;研究小組將於2022年1月開始實施調查性的ATCELL™療法。該公司的ATCELL™(自體間充質幹細胞)輸注療法(“研究性新藥”)研究題為:ATCELL™擴增的自體、脂肪來源的間充質幹細胞通過靜脈輸注部署,用於治療退役軍人和運動員的震盪後綜合徵。這項研究被列在ClinicalTrials.gov上,標識為NCT04744051。
Recruitment and screening were performed at BioSolutions in La Mesa, CA, with over 25 years of collective experience in the fields of medicine and clinical trials from orthopedics to stem cell therapies. BioSolutions is comprised of community-based investigators dedicated to clinical research, overseeing all aspects of clinical trials with an experienced team of clinical research professionals focusing on quality research data while recognizing that speed, responsiveness, and accountability are also core needs.
招募和篩選是在加利福尼亞州拉梅薩的BioSolutions公司進行的,他們在從整形外科到幹細胞療法的醫學和臨牀試驗領域擁有超過25年的集體經驗。BioSolutions由致力於臨牀研究的社區調查人員組成,監督臨牀試驗的所有方面,擁有一支經驗豐富的臨牀研究專業團隊,專注於高質量的研究數據,同時認識到速度、響應和責任也是核心需求。
Principal Investigator, Peter Hanson, MD stated, "I would like to thank our team for all their hard work in successfully recruiting all participants for this study. In light of the recruitment difficulties many studies are experiencing during the pandemic, their dedication and effort has paid off. We look forward to begin participant treatments in the near future."
首席調查員、醫學博士彼得·漢森説:“我要感謝我們的團隊為這項研究成功招募所有參與者所做的辛勤工作。鑑於許多研究在大流行期間面臨招募困難,他們的奉獻和努力得到了回報。我們期待在不久的將來開始參與者治療。”
Overall, it is estimated that the cost of traumatic brain injuries (TBI) in the United States, including concussion injuries, weighs in at $48.3 billion annually of which $31.7 billion is spent on hospitalization costs; an additional $16.6 billion is associated with costs attributed to fatalities. According to the Centers for Disease Control, acute care, and rehabilitation of brain injury patients in the United States costs about $9 billion to $10 billion per year. This does not include indirect costs to society and family caretakers due to lost productivity, work time and earnings, as well as costs linked to providing social services.
總體而言,據估計,在美國,包括腦震盪在內的創傷性腦損傷(TBI)的成本為每年483億美元,其中317億美元用於住院費用;另外166億美元與死亡相關。根據疾病控制中心(Centers For Disease Control)的數據,美國腦損傷患者的急性護理和康復每年花費約90億至100億美元。這不包括由於生產力、工作時間和收入損失而給社會和家庭照顧者帶來的間接成本,以及與提供社會服務相關的成本。
About American CryoStem Corporation
American CryoStem Corporation: (CRYO), founded in 2008, is a clinical-stage biotechnology company, developing and delivering autologous mesenchymal stem cell (MSC) therapies utilizing its "mCMC" (mesenchymal, Chemistry, Manufacturing, and Controls) patented platform consisting of the "Collection-Processing-Cryobanking-Return to Point-of-Care of personalized therapy. The Platform supports a growing pipeline of biologic therapies, products, processes, and international licensing opportunities. The Company's patented platform provides 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 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. Each new collaborative effort is designed to result in additional intellectual property and targeted commercial products to ultimately produce significant future revenue. CRYO is targeting topical applications and hard to treat neurologic diseases; disorders, and conditions that have a large unmet medical need and FDA Orphan Drug designation(s). The Company operates a cGMP compliant, FDA registered laboratory, located in Monmouth Junction, New Jersey, USA, with licensed laboratory operations in Hong Kong, China, and Thailand.
關於美國CryoStem公司
美國冷凍幹細胞公司(CryoStem Corporation):(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,該平臺由“個性化治療的收集-處理-冷藏庫-返回護理點”組成。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。該公司的專利平臺為單個脂肪組織(FAT)收穫提供了加工、儲存和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“按需”生產大量基因匹配的間充質幹細胞(ATCELL),用於未來的個別或後續治療。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。每一項新的合作努力都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,難以治療神經系統疾病、紊亂和有大量未得到滿足的醫療需求和FDA孤兒藥物稱號的疾病。該公司在美國新澤西州的蒙茅斯交界處設有符合cGMP的FDA註冊實驗室,在中國香港特區和泰國有許可的實驗室運營。
For further information please visit: , 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:,發送電子郵件至:info@americancryostem.com,或直接致電732-747-1007與公司聯繫。
SOURCE: American CryoStem Corporation
資料來源:美國CryoStem公司