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.
新泽西州伊顿镇/ACCESSWIRE/2021年12月22日/亚洲网加利福尼亚州圣何塞10月16日电临床阶段生物技术公司、全球许可方和自体细胞加工和疗法的先驱美国CryoStem公司(场外交易代码:CRYO)今天宣布,其临床研究团队已经完成了脑震荡后综合征的研究性新药(IND)第一阶段临床试验的招募工作。生物解决方案临床研究中心正在进行这项单地点、多剂量的盲法研究。
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.
首席调查员(PI)今天宣布,这项研究已经100%招募;研究小组将于2022年1月开始实施调查性的ATCELL™疗法。该公司的ATCELL™(自体间充质干细胞)输注疗法(“研究性新药”)研究题为:ATCELL™扩增的自体、脂肪来源的间充质干细胞通过静脉输注部署,用于治疗退役军人和运动员的震荡后综合征。这项研究被列在ClinicalTrials.gov上,标识为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.
招募和筛选是在加利福尼亚州拉梅萨的BioSolutions公司进行的,他们在从整形外科到干细胞疗法的医学和临床试验领域拥有超过25年的集体经验。BioSolutions由致力于临床研究的社区调查人员组成,监督临床试验的所有方面,拥有一支经验丰富的临床研究专业团队,专注于高质量的研究数据,同时认识到速度、响应和责任也是核心需求。
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."
首席调查员、医学博士彼得·汉森说:“我要感谢我们的团队为这项研究成功招募所有参与者所做的辛勤工作。鉴于许多研究在大流行期间面临招募困难,他们的奉献和努力得到了回报。我们期待在不久的将来开始参与者治疗。”
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.
总体而言,据估计,在美国,包括脑震荡在内的创伤性脑损伤(TBI)的成本为每年483亿美元,其中317亿美元用于住院费用;另外166亿美元与死亡相关。根据疾病控制中心(Centers For Disease Control)的数据,美国脑损伤患者的急性护理和康复每年花费约90亿至100亿美元。这不包括由于生产力、工作时间和收入损失而给社会和家庭照顾者带来的间接成本,以及与提供社会服务相关的成本。
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.
关于美国CryoStem公司
美国冷冻干细胞公司(CryoStem Corporation):(Cryo)成立于2008年,是一家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,该平台由“个性化治疗的收集-处理-冷藏库-返回护理点”组成。该平台支持越来越多的生物疗法、产品、流程和国际许可机会。该公司的专利平台为单个脂肪组织(FAT)收获提供了加工、储存和最终用于美容脂肪转移的机会,或者用于立即或将来对MSCs进行加工。该平台被配置为“按需”生产大量基因匹配的间充质干细胞(ATCELL),用于未来的个别或后续治疗。该公司对其细胞治疗产品线进行了战略定位,以吸引合作伙伴,加快开发新的治疗应用,并改进制造工艺和测试方法。每一项新的合作努力都旨在产生额外的知识产权和有针对性的商业产品,最终产生可观的未来收入。CRYO的目标是局部应用,难以治疗神经系统疾病、紊乱和有大量未得到满足的医疗需求和FDA孤儿药物称号的疾病。该公司在美国新泽西州的蒙茅斯交界处设有符合cGMP的FDA注册实验室,在中国香港特区和泰国有许可的实验室运营。
For further information please visit: , 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:,发送电子邮件至:info@americancryostem.com,或直接致电732-747-1007与公司联系。
SOURCE: American CryoStem Corporation
资料来源:美国CryoStem公司