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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)

美國冷凍系統公佈腦震盪後綜合症(PCS)的 I 期臨床試驗患者治療狀況
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).

新澤西州伊頓敦/配件/2022 年 3 月 4 日/ 美國冷凍科技公司(OTC PINK:CRYO)是臨床階段生物技術公司,全球許可商,以及自體細胞加工和細胞療法的先驅,今天宣布,已達到其 ATCell™ 自體間充質幹細胞療法的中途點,用於腦震盪綜合症(PCS)的 I 期臨床試驗。

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.

該公司的自體間充質幹細胞輸注療法研究藥物是以下協議的單一中心研究的一部分:「ATCell™ 擴展自體,脂肪衍生的間充質幹細胞通過靜脈輸液部署,用於治療退休軍人和運動員腦震盪後綜合徵(PCS)。」BioSolutions 臨床研究中心有限責任公司(「生物解決方案」)正在其位於加利福尼亞州拉梅薩的臨床場所進行患者招聘,篩查和分配研究療法。外科組織收集、ATCELL™ 幹細胞治療和跟進臨床訪問,正在首席研究員彼得·漢森博士的指導下進行。BioSolutions 多學科團隊在醫學領域和從骨科到幹細胞療法的臨床試驗領域擁有超過 25 年的集體經驗。

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."

首席運營官 Anthony Dudzinski 表示:「迄今為止,參與者已經完成了初步篩選過程,符合我們廣泛的包含/排除標準,並開始治療和跟進評估。我們認為,ATCELL™ 用於 PCS 是 FDA 臨床研究的「首創」自體細胞治療方案,該方案能夠成為治療輕度創傷性腦損傷(MTBi)引起腦震盪後綜合徵影響的患者的行業標準。完成臨床研究和 FDA 營銷批准後,治療方法將可用。」

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.

總體而言,據估計,美國的創傷性腦損傷(TBI)的成本,包括腦震盪損傷,每年約為 48.3 億美元,其中 31.7 億美元用於住院費用; 額外的 16.6 億美元與死亡造成的成本有關。根據疾病控制中心的數據,美國腦損傷患者的急性護理和康復費用為每年 9 至 100 億美元。這不包括由於生產力損失,工作時間和收入而導致的社會和家庭照顧者的間接成本,以及與提供社會服務有關的成本。

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

有關更多信息,請訪問:,發送電子郵件到:info@americancryostem.com 或直接致電 732-747-1007 與本公司聯繫。

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.

關於美國冷凍系統
美國冷凍科技公司(OTC PINK:CRYO),是一家臨床階段生物技術公司,全球許可商和自體(自身)細胞加工和療法的先驅。該公司的中央實驗室模型和專利的基礎「CryoStem 平台」是用於治療傷害,疾病和慢性疾病的最佳端到端細胞治療解決方案。通過單次脂肪組織(脂肪)收穫和 AtCellBank™ 冷凍保存,公司創造了個性化的脂肪衍生間質幹細胞輸液療法,旨在根據需要根據需要,最終根據需要將連續多種基因匹配細胞治療提供一致的樣品直接送到患者點的護理點。American CryoStem 致力於通過開發和提供有效的尖端幹細胞療法來幫助全球醫生,醫院和診所改善臨床結果,從而改善患者健康和生活質量。該公司在新澤西州蒙茅斯交界處擁有 FDA 註冊的符合 cGMP 的實驗室。

SOURCE: American CryoStem Corporation

來源: 美國冷凍系統公司


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