更新于：2024-11-01

Renishaw Neuro Solutions Ltd.

子公司|

Gloucestershire, United Kingdom

子公司|

Gloucestershire, United Kingdom

更新于：2024-11-01

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项与 Renishaw Neuro Solutions Ltd. 相关的临床试验

EUCTR2017-005170-19-FI / Not yet recruiting临床1/2期

A Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions

开始日期2019-03-06

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Renishaw Neuro Solutions Ltd.

100 项与 Renishaw Neuro Solutions Ltd. 相关的临床结果

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0 项与 Renishaw Neuro Solutions Ltd. 相关的专利（医药）

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项与 Renishaw Neuro Solutions Ltd. 相关的文献（医药）

2024-07-09·ACS Nano

The Influence of Size on the Intracranial Distribution of Biomedical Nanoparticles Administered by Convection-enhanced Delivery in Minipigs

Article

作者: Poulsen, Frantz Rom ; Williams, Julia ; Johnson, David ; Halle, Bo ; Straathof, Natan Johannes Willem ; Woolley, Max ; Ravn, Katharina ; Langhorn, Louise ; Kidd, Charlotte ; Amirrashedi, Mahsa ; Thisgaard, Helge ; Jensen, Andreas Ingemann ; Pedersen, Christian G T ; Tang, Qing

Because of the blood-brain barrier (BBB), successful drug delivery to the brain has long been a key objective for the medical community, calling for pioneering technologies to overcome this challenge. Convection-enhanced delivery (CED), a form of direct intraparenchymal microinfusion, shows promise but requires optimal infusate design and real-time distribution monitoring. The size of the infused substances appears to be especially critical, with current knowledge being limited. Herein, we examined the intracranial administration of polyethylene glycol (PEG)-coated nanoparticles (NPs) of various sizes using CED in groups of healthy minipigs (n = 3). We employed stealth liposomes (LIPs, 130 nm) and two gold nanoparticle designs (AuNPs) of different diameters (8 and 40 nm). All were labeled with copper-64 for quantitative and real-time monitoring of the infusion via positron emission tomography (PET). NPs were infused via two catheters inserted bilaterally in the putaminal regions of the animals. Our results suggest CED with NPs holds promise for precise brain drug delivery, with larger LIPs exhibiting superior distribution volumes and intracranial retention over smaller AuNPs. PET imaging alongside CED enabled dynamic visualization of the process, target coverage, timely detection of suboptimal infusion, and quantification of distribution volumes and concentration gradients. These findings may augment the therapeutic efficacy of the delivery procedure while mitigating unwarranted side effects associated with nonvisually monitored delivery approaches. This is of vital importance, especially for chronic intermittent infusions through implanted catheters, as this information enables informed decisions for modulating targeted infusion volumes on a catheter-by-catheter, patient-by-patient basis.

2023-07-01·Movement disorders : official journal of the Movement Disorder Society

Intraputamenal Cerebral Dopamine Neurotrophic Factor in Parkinson's Disease: A Randomized, Double-Blind, Multicenter Phase 1 Trial.

Article

作者: Almqvist, Per ; Saarma, Mart ; Fazio, Patrik ; Kivisaari, Riku ; Bjartmarz, Hjalmar ; Rinne, Juha ; Kerstens, Vera ; Andréasson, Mattias ; Lind, Göran ; Scheperjans, Filip ; Levo, Reeta ; Gray, William ; Johnson, David ; Holmnäs, Rebecka ; Williams, Julia ; Johansson, Jarkko ; Marjamaa, Johan ; Widner, Håkan ; Svenningsson, Per ; Huttunen, Henri J ; Paul, Gesine ; Varrone, Andrea ; Grubor, Irena ; Halldin, Christer ; Koskinen, Jani ; Sjögren, Magnus ; Brady, Alan ; Eerola-Rautio, Johanna ; Dailami, Narges ; Woolley, Max ; Mertsalmi, Tuomas ; Kulesskaya, Natalia ; Booms, Sigrid ; Resendiz-Nieves, Julio

BACKGROUNDCerebral dopamine neurotrophic factor (CDNF) is an unconventional neurotrophic factor that protects dopamine neurons and improves motor function in animal models of Parkinson's disease (PD).OBJECTIVEThe primary objectives of this study were to assess the safety and tolerability of both CDNF and the drug delivery system (DDS) in patients with PD of moderate severity.METHODSWe assessed the safety and tolerability of monthly intraputamenal CDNF infusions in patients with PD using an investigational DDS, a bone-anchored transcutaneous port connected to four catheters. This phase 1 trial was divided into a placebo-controlled, double-blind, 6-month main study followed by an active-treatment 6-month extension. Eligible patients, aged 35 to 75 years, had moderate idiopathic PD for 5 to 15 years and Hoehn and Yahr score ≤ 3 (off state). Seventeen patients were randomized to placebo (n = 6), 0.4 mg CDNF (n = 6), or 1.2 mg CDNF (n = 5). The primary endpoints were safety and tolerability of CDNF and DDS and catheter implantation accuracy. Secondary endpoints were measures of PD symptoms, including Unified Parkinson's Disease Rating Scale, and DDS patency and port stability. Exploratory endpoints included motor symptom assessment (PKG, Global Kinetics Pty Ltd, Melbourne, Australia) and positron emission tomography using dopamine transporter radioligand [¹⁸ F]FE-PE2I.RESULTSDrug-related adverse events were mild to moderate with no difference between placebo and treatment groups. No severe adverse events were associated with the drug, and device delivery accuracy met specification. The severe adverse events recorded were associated with the infusion procedure and did not reoccur after procedural modification. There were no significant changes between placebo and CDNF treatment groups in secondary endpoints between baseline and the end of the main and extension studies.CONCLUSIONSIntraputamenally administered CDNF was safe and well tolerated, and possible signs of biological response to the drug were observed in individual patients. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

2022-12-01·Journal of The Royal Society Interface

In vivo measurement of human brain material properties under quasi-static loading

Article

作者: Bennion, Nicholas J. ; Woolley, Max ; Evans, Sam L. ; Marshall, David ; Potts, Matthew ; Zappalá, Stefano

Computational modelling of the brain requires accurate representation of the tissues concerned. Mechanical testing has numerous challenges, in particular for low strain rates, like neurosurgery, where redistribution of fluid is biomechanically important. A finite-element (FE) model was generated in FEBio, incorporating a spring element/fluid–structure interaction representation of the pia–arachnoid complex (PAC). The model was loaded to represent gravity in prone and supine positions. Material parameter identification and sensitivity analysis were performed using statistical software, comparing the FE results to human in vivo measurements. Results for the brain Ogden parameters µ , α and k yielded values of 670 Pa, −19 and 148 kPa, supporting values reported in the literature. Values of the order of 1.2 MPa and 7.7 kPa were obtained for stiffness of the pia mater and out-of-plane tensile stiffness of the PAC, respectively. Positional brain shift was found to be non-rigid and largely driven by redistribution of fluid within the tissue. To the best of our knowledge, this is the first study using in vivo human data and gravitational loading in order to estimate the material properties of intracranial tissues. This model could now be applied to reduce the impact of positional brain shift in stereotactic neurosurgery.

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100 项与 Renishaw Neuro Solutions Ltd. 相关的转化医学

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