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American CryoStem Announces Patient Treatment Status for its Phase I Clinical Trial for Post-Concussion Syndrome (PCS)

American CryoStem Announces Patient Treatment Status for its Phase I Clinical Trial for Post-Concussion Syndrome (PCS)

American CryoStem 宣布其脑震荡后综合征 (PCS) I 期临床试验的患者治疗状况
Accesswire ·  2022/03/04 06:06

EATONTOWN, NJ / ACCESSWIRE / March 4, 2022 / American CryoStem Corporation (OTC PINK:CRYO) a clinical stage biotechnology company, global licensor, and a pioneer in autologous cellular processing and cellular therapies, announced today that it has reached the midway point of its ATCell™ autologous mesenchymal stem cell therapy for Phase I Clinical Trial for Post-concussion syndrome (PCS).

新泽西州伊顿敦/ACCESSWIRE /2022 年 3 月 4 日/ 临床阶段生物技术公司、全球许可方、自体细胞处理和细胞疗法的先驱美国CryoStem公司(OTC PINK: CRYO)今天宣布,其用于脑震荡后综合征(PCS)I期临床试验的atCell™ 自体间充质干细胞疗法已达到中点。

The Company's autologous mesenchymal stem cell infusion therapy Investigational Drug is part of a single center study under the protocol entitled: "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." Patient recruitment, screening and dispensing of the research therapy is being conducted by BioSolutions Clinical Research Center, LLC ("BioSolutions") at its clinical site located in La Mesa, CA. The surgical tissue collection, ATCELL™ stem cell treatments, and follow-up clinical visits are being conducted under the direction of Dr. Peter Hanson, Principal Investigator. The BioSolutions multidisciplinary team has over 25 years of collective experience in the fields of medicine and clinical trials from orthopedics to stem cell therapies.

该公司的自体间充质干细胞输液疗法研究药物是该方案下的一项单中心研究的一部分,该研究的标题是:“atCell™ 通过静脉输液部署用于治疗退役军人和运动员的脑震荡后综合症(PCS)的扩增自体、脂肪衍生的间充质干细胞。”BioSolutions临床研究中心有限责任公司(“BioSolutions”)正在其位于加利福尼亚州拉梅萨的临床基地进行研究疗法的患者招募、筛查和分配。手术组织采集、ATCELL™ 干细胞治疗和后续临床就诊正在首席研究员彼得·汉森博士的指导下进行。BioSolutions 多学科团队在从骨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。

Anthony Dudzinski, COO, stated, "To date, participants have completed the initial screening process, meeting our extensive inclusion/exclusion criteria, and treatments and follow up assessments have begun. We believe that ATCELL™ for PCS is a 'first of its kind' autologous cellular therapy protocol subject to FDA clinical studies that has the ability to become an industry standard to treat patients suffering from the effects of post-concussion syndrome resulting from mild traumatic brain (mTBI) injuries. Treatments will become available upon completion of clinical studies and FDA marketing approval."

首席运营官安东尼·杜津斯基表示:“迄今为止,参与者已经完成了初步筛查过程,符合我们广泛的纳入/排除标准,治疗和随访评估已经开始。我们认为,ATCELL™ for PCS 是 “首创” 的自体细胞治疗方案,有待美国食品药品管理局临床研究,有能力成为治疗因轻度创伤性脑损伤 (mtBI) 损伤而遭受脑震荡后综合征影响的患者的行业标准。治疗将在完成临床研究和获得FDA上市批准后上市。”

Overall, it is estimated that the cost of traumatic brain injuries (TBI) in the United States, including concussion injuries, is approximately $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 $9 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,包括脑震荡损伤在内的美国创伤性脑损伤(TBI)每年约为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的成本有关。根据疾病控制中心的数据,美国脑损伤患者的急性护理和康复每年花费90亿至100亿美元。这不包括因生产力、工作时间和收入损失而给社会和家庭看护人带来的间接成本,以及与提供社会服务有关的成本。

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。

About American CryoStem
American CryoStem Corporation (OTC PINK:CRYO), is a clinical stage biotechnology company, global licensor and a pioneer in autologous (one's own) cellular processing and therapies. The Company's centralized laboratory model and patented foundational "CryoStem Platform" is a best-in-class, end-to-end cellular therapy solution to treat injuries, disorders and chronic diseases. Through a single adipose-tissue (fat) harvest and ATCELLBank™ cryopreservation, the Company creates personalized adipose-derived mesenchymal stem cell infusion therapies designed to ultimately deliver consistent samples for successive multiple treatments of genetically matched cells as needed, directly to patient point-of-care, on demand. American CryoStem is dedicated to helping the world's physicians, hospitals, and clinics improve clinical outcomes by developing and delivering effective leading-edge stem cell therapies that improve patient health and quality of life. The Company maintains an FDA registered cGMP compliant laboratory located in Monmouth Junction, New Jersey.

关于美国 CryoStem
American CryoStem Corporation(OTC PINK: CRYO)是一家临床阶段的生物技术公司,是全球许可方,也是自体(自己的)细胞处理和疗法的先驱。该公司的集中化实验室模式和获得专利的基础 “CryoStem Platform” 是治疗损伤、疾病和慢性病的一流端到端细胞疗法解决方案。通过单一脂肪组织(脂肪)采集和AtcellBank™ 低温保存,该公司创建了个性化的脂肪衍生间充质干细胞输液疗法,旨在最终根据需要为基因匹配细胞的连续多次治疗提供一致的样本,按需直接送到患者床边。American CryoStem 致力于通过开发和提供有效的前沿干细胞疗法来改善患者健康和生活质量,从而帮助世界各地的医生、医院和诊所改善临床结果。该公司在新泽西州蒙茅斯交界处设有一个符合美国食品药品管理局注册的cGMP合规实验室。

SOURCE: American CryoStem Corporation

来源: 美国 CryoStem 公司


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