Parkinson's Disease Clinical Trial Uses Intraoperative MRI to Guide Precision Implantation of Patients' Own Autologous Replacement Neurons
Parkinson's Disease Clinical Trial Uses Intraoperative MRI to Guide Precision Implantation of Patients' Own Autologous Replacement Neurons
Aspen Neuroscience Announces MRI-Guided Transplantation Approach for ASPIRO Clinical Trial with the ClearPoint Navigation System
Aspen Neuroscience宣佈MRI引導的ASPIRO臨床試驗移植方案，請使用ClearPoint導航系統。使用ClearPoint導航系統。
SAN DIEGO, June 20, 2024 /PRNewswire/ -- Aspen Neuroscience, Inc. announced today that it is utilizing the MRI-guided ClearPoint Navigation System for all patients enrolled in the recently launched ASPIRO Phase 1/2a clinical trial for transplantation of dopaminergic neuron precursor cells (DANPCs) in patients with Parkinson's Disease (PD). ASPIRO is an open label trial to assess safety and tolerability of ANPD001, an autologous, dopaminergic neuron cell replacement therapy for participants with moderate to severe PD.
2024年6月20日，加利福尼亞州聖迭戈 /美通社/--Aspen Neuroscience公司宣佈，針對帕金森病患者的多巴胺能神經元前體細胞(DANPCs)移植的ASPIRO I/IIa相臨床試驗中，將爲所有患者使用MRI引導的ClearPoint導航系統。ASPIRO是一個開放標籤試驗，旨在評估ANPD001的安全性和耐受性，這是一種自體多巴胺能神經元細胞替代療法，針對中度至重度帕金森病患者。
"By the time of diagnosis, it is common for people with Parkinson's to have lost the majority of dopaminergic neurons, leading to progressive loss of motor and neurological function," explained Edward Wirth III, MD, PhD, Chief Medical Officer of Aspen Neuroscience. "To replace these lost cells, we must target a very specific area of the brain with a high degree of surgical precision. Utilizing the latest advances in intraoperative MRI guided techniques provided by the ClearPoint system, the patient's new cells are transplanted, one microliter at a time, to the exact area where they are most needed."
"帕金森病被診斷時，患者通常已經失去了大部分多巴胺能神經元，導致逐漸失去運動和神經功能，"Aspen Neuroscience的首席醫療官Edward Wirth III, MD, PhD解釋道。"爲了替換這些失去的細胞，我們必須針對大腦中非常特定的區域進行高度精準的手術。利用ClearPoint系統提供的最新顯微MRI引導技術，患者的新細胞會被移植到最需要的確切區域，每次只注入一微升。"
These DANPCs are transplanted to the putamen, a small section located in the mid-brain, in a single transplantation procedure under ClearPoint MRI guidance, using the SmartFlow Cannula and the Aspen Metered Delivery Syringe (AMDS). This surgical approach was developed by the trial's lead neurosurgeon and renowned MRI-guided stereotactic neurosurgery pioneer Paul Larson, MD, FAANS, professor of neurosurgery at the University of Arizona College of Medicine – Tucson and neurosurgeon at Banner University Medical Center, Tucson.
這些DANPCs將在一個單一的移植手術下，在ClearPoint MRI指導下移植到位於中腦的小區域putamen中，使用SmartFlow Cannula和Aspen Metered Delivery Syringe (AMDS)。這種手術方法是由該試驗的首席神經外科醫生和著名的MRI引導立體定向神經外科開創者Paul Larson, MD, FAANS，神經外科的教授在亞利桑那大學醫學院-圖森校區和Banner University醫療中心擔任神經外科醫生開發的。
"We are honored to be a part of such an important and groundbreaking study to demonstrate the ability of personalized medical approaches for treating neurodegenerative conditions," explained Jeremy Stigall, Chief Business Officer at ClearPoint Neuro. "The ClearPoint Neuro Navigation System is being used successfully in more than 80 centers worldwide for multiple applications, and investigational gene and cell therapy trials. We are thrilled to partner with Aspen to support the first multi-center trial for an autologous neuron replacement therapy for Parkinson's disease."
"我們很榮幸能成爲展示個性化醫療方法治療神經退行性疾病能力的重要和開創性研究的一部分，"ClearPoint Neuro的首席業務官Jeremy Stigall解釋道。"ClearPoint Neuro導航系統已在全球80多箇中心成功應用於多個應用場景，以及研究基因和細胞療法。我們很高興能與Aspen合作，支持第一個針對帕金森病的自體神經元替代療法的多中心試驗。"
The ClearPoint System utilizes intraprocedural MR images to provide real-time navigational instruction for the neurosurgeon, and confirmation that the desired anatomical target has been reached with submillimetric accuracy. Combined with The SmartFlow Cannula, which is less than 2 millimeters in diameter, this allows minimally-invasive delivery of therapeutic agents in a patient's brain.
ClearPoint系統利用術中MR圖像爲神經外科醫生提供實時導航指導，以及確認達到所需解剖目標的超亞毫米精度。結合SmartFlow Cannula，其直徑小於2毫米，這允許在患者的大腦中進行微創遞送治療劑。
About the ASPIRO Trial
The Autologous-derived Study of a Parkinson's Investigational Regenerative therapy in an Open-label trial (ASPIRO) is a Phase 1/2a clinical trial to assess the safety, tolerability, and potential efficacy of ANPD001 in patients with moderate to severe Parkinson's disease. The dose escalation study includes patients 50–70 years of age and excludes patients with cognitive impairment and other comorbidities that could preclude treatment. All enrolled patients are under the care of a movement disorder specialist.
關於ASPIRO試驗
自體源性帕金森病研究開放標籤試驗（ASPIRO）是一項I/IIa臨床試驗，旨在評估ANPD001對中度至重度帕金森病患者的安全性、耐受性和潛在療效。劑量遞增研究包括50-70歲的患者，排除認知障礙患者和其他可能排除治療的合併疾病患者。所有招募的患者都在運動障礙專家的治療下。
The primary study endpoint is safety and tolerability of ANPD001. Secondary endpoints include improvement in "on" time, when patients experience periods of symptom control, and improvements in motor symptoms and quality of life based on standard Parkinson's disease rating scales.
主要研究終點是ANPD001的安全性和耐受性。次要終點包括根據標準帕金森病評分尺度改善"開機"時間（患者經歷症狀控制期）以及運動症狀和生活質量的改善。
About ANPD001
ANPD001 is an investigational autologous neuronal replacement therapy being studied as a regenerative therapy for PD. Aspen's personalized approach means that patients do not require immunosuppressive drugs to counteract the body's immune response against foreign cells.
關於ANPD001
ANPD001是一種被研究作爲PD再生醫學的實驗性自體神經元替代療法。Aspen的個性化方法意味着患者不需要免疫抑制藥物來抵消身體對外來細胞的免疫反應。
Aspen's manufacturing process starts from a small sample of the patient's own skin cells, followed by reprogramming to induced pluripotent stem cells (iPSCs) and then differentiation of the iPSCs into DANPCs. These DANPCs are transplanted into the putamen, replacing cells that were lost or damaged due to disease. The quality of each person's cells is assessed at every manufacturing stage using Aspen's proprietary machine learning-based genomics tests.
Aspen的製造過程從患者自己的皮膚樣本開始，然後經過重新編程爲誘導性多能幹細胞（iPSC），再將iPSC分化爲DANPCs。利用Aspen的專有的基於機器學習的基因組學檢測方法，在每個製造階段評估每個人的細胞質量。
About ClearPoint Neuro
ClearPoint Neuro, Inc. (NASDAQ: CLPT) is a device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine. The Company uniquely provides both established clinical products as well as pre-clinical development services for controlled drug and device delivery. The Company's flagship product, the ClearPoint Neuro Navigation System, has FDA clearance and is CE-marked. ClearPoint Neuro is engaged with healthcare and research centers in North America, Europe, Asia, and South America. The Company is also partnered with the most innovative pharmaceutical / biotech companies, academic centers, and contract research organizations, providing solutions for direct CNS delivery of therapeutics in pre-clinical studies and clinical trials worldwide. To date, thousands of procedures have been performed and supported by the Company's field-based clinical specialist team, which offers support and services to our customers and partners worldwide. For more information, please visit .
關於ClearPoint Neuro
ClearPoint Neuro, Inc. (NASDAQ: CLPT)是一家提供精準的導航切入腦和脊髓的設備、細胞和基因療法的公司。該公司獨特地提供成熟的臨床產品以及受控藥物和設備遞送的臨床前開發服務。公司的旗艦產品ClearPoint Neuro Navigation System已獲得FDA認證，並獲得CE標誌。ClearPoint Neuro與北美、歐洲、亞洲和南美的醫療保健和研究中心建立業務往來。該公司還與最具創新性的製藥/生物技術公司、學術中心和合同研究機構合作，在全球範圍內爲治療在臨床前研究和臨床試驗中的直接中樞神經系統遞送解決方案。到目前爲止，該公司的現場臨床專家團隊支持和服務了數千次手術。有關更多信息，請訪問.
About Aspen Neuroscience
Headquartered in San Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on autologous regenerative medicine. The company's patient-derived iPSC platform is used to create personalized therapies to address diseases with high unmet medical needs, beginning with autologous neuron replacement for Parkinson's disease.
關於Aspen Neuroscience
總部位於聖迭戈的Aspen Neuroscience, Inc.是一家臨床開發階段的私人公司，專注於自體再生醫學。該公司的患者衍生的iPSC平台用於創建個性化療法，以解決高度不滿足的醫學需要的疾病，其中包括帕金森病的自體神經元替代治療。
Aspen combines cell biology with the latest machine learning and genomic approaches to investigate patient-specific, restorative cell treatments. The company has developed a best-in-class platform to create and optimize pluripotent-derived cell therapies, which includes in-house bioinformatics, manufacturing and quality control. For more information and important updates, please visit .
Aspen將細胞生物學與最新的機器學習和基因組方法相結合，研究特異性患者修復性細胞治療。該公司已開發了最佳的平台，以創建和優化多能細胞治療方案，其中包括內部生物信息學、製造和質量控制。有關更多信息和重要更新，請訪問.
SOURCE Aspen Neuroscience, Inc.
資料來源Aspen Neuroscience, Inc。
譯文內容由第三人軟體翻譯。