Schreiner Thomas Gabriel, Menéndez-González Manuel, Schreiner Oliver Daniel, Ciobanu Romeo Cristian
Department of Medical Specialties III, Faculty of Medicine, "Grigore T. Popa" University of Medicine and Pharmacy, 700115 Iasi, Romania.
First Neurology Clinic, "N. Oblu" Clinical Emergency Hospital, 700309 Iasi, Romania.
Biomedicines. 2025 Sep 5;13(9):2167. doi: 10.3390/biomedicines13092167.
Neurodegenerative diseases (NDDs) pose an immense global health burden, and developing effective treatments is hindered by the blood-brain barrier (BBB). Intrathecal (IT) administration of therapeutics directly into the cerebrospinal fluid (CSF) bypasses the BBB, offering a promising avenue for antisense oligonucleotides (ASOs), gene therapies, antibodies, and stem cells for these disorders. This review synthesizes the current landscape of IT therapies for Alzheimer's disease, Parkinson's disease, Huntington's disease, and Amyotrophic Lateral Sclerosis based on the current literature and ClinicalTrials.gov. We highlight key trials and approaches, including the success of ASOs in spinal muscular atrophy and recent progress in other NDDs. However, the efficacy of these novel treatments is often constrained by the limitations of first-generation IT delivery systems, which struggle with uneven distribution, systemic leakage, and the demands of modern biologics. Drawing from recent analyses, we underscore the critical shortcomings of current devices and point out the innovations needed in shaping next-generation systems: subcutaneous access ports, CSF flow platforms, AI-driven adaptive dosing, nanoporous membranes, intrathecal pseudodelivery, and hydrogel scaffolds. We conclude by emphasizing the urgent need for these advanced IT drug delivery systems, alongside rigorous comparative assessments, cost-benefit analyses, and clear regulatory pathways to fully realize the potential of emerging CNS therapies and transform NDD management.
神经退行性疾病(NDDs)给全球健康带来了巨大负担,而血脑屏障(BBB)阻碍了有效治疗方法的开发。将治疗药物鞘内(IT)注射到脑脊液(CSF)中可绕过血脑屏障,为针对这些疾病的反义寡核苷酸(ASOs)、基因疗法、抗体和干细胞提供了一条有前景的途径。本综述基于当前文献和ClinicalTrials.gov,综合了针对阿尔茨海默病、帕金森病、亨廷顿病和肌萎缩侧索硬化症的鞘内治疗的现状。我们重点介绍了关键试验和方法,包括ASOs在脊髓性肌萎缩症中的成功以及在其他神经退行性疾病中的最新进展。然而,这些新型治疗方法的疗效往往受到第一代鞘内给药系统局限性的制约,这些系统存在分布不均、全身渗漏以及现代生物制剂需求等问题。借鉴近期分析,我们强调了当前设备的关键缺点,并指出了塑造下一代系统所需的创新:皮下接入端口、脑脊液流动平台、人工智能驱动的自适应给药、纳米多孔膜、鞘内假给药和水凝胶支架。我们最后强调迫切需要这些先进的鞘内药物递送系统,同时进行严格的比较评估、成本效益分析以及明确的监管途径,以充分实现新兴中枢神经系统疗法的潜力并改变神经退行性疾病的管理。