AAN 2026: BlueRock reports positive safety data for bemdaneprocel in Parkinson's. Bemdaneprocel is a cell therapy composed of human embryonic stem cell-derived midbrain dopaminergic neuron progenitor cells. On 21 April, at the 2026 American Academy of Neurology (AAN) meeting, BlueRock Therapeutics, a wholly owned, independently operated subsidiary of Bayer AG, announced positive results from its Phase I open-label two-year study (NCT04802733) evaluating bemdaneprocel, an investigational stem cell-derived therapy, in Parkinson's disease (PD). The study aimed to assess predefined safety, tolerability, and feasibility criteria at one year, with trends towards improvement or stability in clinical assessments observed through two years post transplantation. The trial met its primary endpoint, with bemdaneprocel proving to be generally well-tolerated, with treatment-emergent adverse events (TEAEs) being mild or moderate in severity and unrelated to the cell transplant. Bemdaneprocel is an investigational cell therapy composed of human embryonic stem cell-derived midbrain dopaminergic neuron progenitor cells. In the trial, bemdaneprocel was injected bilaterally into the postcommissural putamen in a single surgical session. Prior to the procedure, participants were subject to a one-year immunosuppression regimen. Following study completion, all participants enrolled in a continued-evaluation study for assessment through five years post transplantation. There were 12 participants enrolled in the study, which had a median age of 67 years and the median time since PD diagnosis was nine years. The safety data displayed was positive. Through three years post-transplantation, 12 participants experienced 112 TEAEs, although they were mostly mild or moderate in severity and none were related to the transplanted cells. There were eight treatment-emergent serious adverse events reported, but all were unrelated to the transplanted cells or the prior immunosuppression. Furthermore, there were no deaths or graft-induced dyskinesias and no intracerebral hemorrhages or mass lesions were observed by magnetic resonance imaging (MRI). Secondary endpoints exploring efficacy included evidence of cell survival, and mean (SD) changes from baseline in patient-reported ON times without troublesome dyskinesia (+2.1 hours (3.2)), and OFF times were (−2.0 hours (3.2)), and MDS-UPDRS Part III ON scores (−5.7 points (7.5)) and OFF scores (−17.9 points (8.5)), all showing trends towards improvement. This clinical data indicates that bemdaneprocel may have a place in the PD treatment landscape and could potentially be the first ever disease-modifying cell therapy to enter the market. However, bemdaneprocel is not alone as a cell therapy in clinical development for PD and is likely to face competition from other cell therapies such as Aspen Neuroscience's sasineprocel, which is in Phase II development. In a challenging clinical landscape where many have failed to show disease modification, both bemdaneprocel and sasineprocel are likely to face similar challenges to predecessors in demonstrating longer term disease halting or reversal effects. BlueRock will have to establish that its stem-cell derived therapy is a safe and viable long-term treatment throughout its development program. By doing so, it would be able to ensure bemdaneprocel is in the race to become the disease-modifying therapy of choice in the future PD landscape. Competitors such as Aspen Neuroscience's sasineprocel, an autologous induced pluripotent stem cell (iPSC)-derived dopaminergic neuron precursor cell (DANPC) therapy, have also exhibited promising safety data, as well as early cell survival. The challenge for both these therapies, is that they must address immunogenicity issues to reach the latter stages of development. In summary, the longer-term trial results suggest that bemdaneprocel demonstrates a promising safety profile and early clinical benefits in patients with PD, supported by both functional and imaging evidence. While these findings highlight its potential as a novel, first-in-class stem cell-derived therapy, its ultimate success will depend on proving disease modifying effects in larger Phase III trials, as well as differentiation from other cell therapies in development, which will determine its positioning in the PD treatment paradigm. Give your business an edge with its leading industry insights.

BlueRock Therapeutics elevates biopharmaceutical agility with NexInfo and Oracle Cloud Applications. BlueRock Therapeutics, a pioneering biotechnology company advancing cell-based therapies for neurological, cardiovascular, and immune disorders, recognized the urgent need to eliminate system fragmentation and build an integrated digital backbone to support its rapidly growing operations across R&D, manufacturing, supply chain, and finance. As a high-growth therapeutic developer with complex batch-based production, stringent regulatory oversight, and multi-site supply chain operations, BlueRock faced increasing challenges in managing material flow, production planning, quality control, and financial visibility using disconnected legacy tools. Manual workflows slowed operational efficiency, hindered compliance readiness, and reduced the organization's ability to scale with confidence. To accelerate its transformation and future-proof its operations, BlueRock partnered with NexInfo - an Oracle Cloud implementation leader - to deploy a comprehensive Oracle Cloud ERP and Supply Chain suite. The initiative aimed to create a unified, intelligent, and GxP-compliant digital ecosystem enabling real-time visibility, automated controls, and streamlined manufacturing and supply chain execution. About BlueRock Therapeutics BlueRock Therapeutics is a leading developer of regenerative cell therapies designed to restore human function and improve quality of life for patients with severe neurological, cardiac, and immunological conditions. With a mission to unlock the power of cell engineering, the company operates sophisticated manufacturing and research environments that demand precision, traceability, and end-to-end operational transparency. Replaced System: Coupa Oracle Cloud Modules Implemented: Supply Chain Planning, Procurement, Inventory Management, Manufacturing, Quality Management, Sales Order Management, Accounts Payable, Cash Management Deployment Region: North America Industry: Biotechnology & Biopharmaceuticals As BlueRock scaled production and expanded its clinical and commercial operations, legacy systems and manual processes created operational bottlenecks and limited the company's ability to maintain full visibility across the product lifecycle. * Fragmented Supply Chain Visibility: Disconnected systems hindered planning accuracy and material readiness. * Manual Procurement Workflows: Limited spend control and delayed supplier approvals affected sourcing efficiency. * Inefficient Inventory Tracking: Lack of real-time, compliant traceability across materials and batches. * Complex Manufacturing Processes: Manual batch execution and scheduling slowed throughput. * Limited Order-to-Cash Visibility: Disjointed order management impacted fulfillment and revenue timelines. * Decentralized Financial Operations: Manual AP and cash workflows delayed payments and constrained cash visibility. Collectively, these challenges hindered BlueRock's ability to operate with efficiency, precision, and regulatory confidence. Partnering with NexInfo: Building a Modern, Intelligent Biotech Enterprise With over 70% of biotechnology firms citing system fragmentation as a barrier to scale, the need for a unified digital backbone has never been clearer. Recognizing the need for a scalable and compliant system landscape, BlueRock partnered with NexInfo to redesign its enterprise architecture using Oracle Cloud Applications. NexInfo brought deep expertise in biopharmaceutical operations, GxP-aligned deployments, and cloud-enabled supply chain modernization. Together, they created a fully integrated, automated, and insight-driven platform supporting the complexity of advanced therapeutics manufacturing. The Solution: An Integrated Oracle Cloud Digital Backbone NexInfo implemented an end-to-end suite of Oracle Cloud modules to digitize, unify, and automate BlueRock's core operations. Unified demand - supply forecasting and improved material availability. Centralized sourcing, automated approvals, and improved supplier collaboration. Real-time visibility with lot and serial traceability across all sites. Standardized batch processes, automated shop-floor data capture, and optimized capacity planning. Integrated digital inspections, non-conformance management, and complete GxP traceability. Streamlined order-to-cash lifecycle integrated with inventory and manufacturing. Automated invoice processing and real-time cash visibility. BlueRock's transformation delivered measurable gains across the organization: * End-to-end supply chain visibility for proactive planning. * Centralized and compliant procurement operations across departments. * Optimized inventory and material traceability supporting FDA audits. * Digitally powered manufacturing with higher throughput. * Integrated quality controls ensuring full GxP compliance. * Stronger financial governance with automated AP and improved cash control. * Data-driven operational insights enabling faster decision-making. * Unified supply chain, manufacturing, and financial visibility * Automated procurement, fulfillment, and batch execution BlueRock's journey sets a benchmark for how advanced therapeutics organizations can unlock agility, compliance, and operational excellence through modern cloud technologies. About NexInfo NexInfo is a global Oracle Cloud consulting and implementation partner specializing in supply chain, ERP, manufacturing, and financial transformation. With over two decades of experience across life sciences, biotech, healthcare, manufacturing, and high-tech industries, NexInfo delivers: * Deep expertise in biopharma supply chain and manufacturing * World-class program governance and risk management NexInfo's global team of cloud architects, domain experts, and regulatory specialists enables organizations to accelerate digital transformation while ensuring operational continuity, compliance, and scalability. NexInfo's experts are available to assist with Oracle Cloud assessments, implementation planning, or end-to-end digital transformation support tailored to your industry. Accelerate business operations. Greater flexibility at a lower cost, speak with NexInfo Solutions, Inc. today!

Newsletter Signup - Under Article / In Page"*" indicates required fields Parkinson’s disease is an extremely complex condition to treat. Although there are medications available that can help relieve symptoms, there are still no approved therapies that slow down the progression of the underlying disease. But the biotech industry has not given up on finding new types of treatments that could potentially change the outcome for people suffering from the debilitating condition, and recent news of positive early-stage results for stem cell therapies has produced new hope for Parkinson’s patients.What are the causes of Parkinson’s disease and current therapeutic approaches?Although the underlying cause of Parkinson’s is unknown, scientists do know that the disease results from a loss of neurons in the substantia nigra region of the brain that make the chemical dopamine, which plays a crucial role in the brain’s reward system, influencing feelings of pleasure, motivation, and movement, as well as impacting mood, attention, learning, and memory. The loss of these neurons subsequently causes dopamine levels to plummet, which is ultimately the driving force behind why patients eventually experience such troublesome symptoms – these generally occur when around 80% of neurons have failed.Right now, the main treatment for Parkinson’s aims to increase the levels of dopamine in the brain. The drug levodopa is considered to be the most effective option, and is often combined with other medications to enhance its effectiveness and reduce side effects. However, not all patients respond to these drugs, and in some cases, doctors even perform surgery to run electrodes deep into the brain to help alleviate tremors and other symptoms.How can stem cell therapy treat Parkinson’s?But what if Parkinson’s could be treated directly at its source by actually restoring the lost neurons?That is exactly what stem cell therapies aim to do