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).
Aspen Neuroscience Announces MRI-Guided Transplantation Approach for ASPIRO Clinical Trial with the ClearPoint® Navigation System 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. “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.” 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. “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.” 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. About the ASPIRO Trial 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. About ANPD001 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. About ClearPoint Neuro About Aspen Neuroscience 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 https://www.aspenneuroscience.com. View original content to download multimedia:https://www.prnewswire.com/news-releases/parkinsons-disease-clinical-trial-uses-intraoperative-mri-to-guide-precision-implantation-of-patients-own-autologous-replacement-neurons-302177527.html SOURCE Aspen Neuroscience, Inc. | ||
Company Codes: NASDAQ-NMS:CLPT |