UK-based engineering technologies company,Renishaw, has announced a milestone in a medical study seeking to help sufferers with progressive nervous system disorder Parkinson disease.该研究着眼于专利的核内药物输送装置，是与药品专家的联合阶段1-2临床研究的完成Herantis Pharma.
The device played a critical role in the investigation of cerebral dopamine neurotrophic factor (CDNF) as a treatment for Parkinson’s disease.
Initial results are promising, as they indicate predictable and accurate placement of the device as well as significant efficacy and safety of both the device and CDNF.
帕金森氏病
帕金森氏病is a neurodegenerative disease, caused by the progressive break-down of neurons responsible for the synthesis of dopamine in the brain. Primary symptoms include involuntary shaking, muscle stiffness, and the slow down of movement. Non-motor symptoms include sleeping difficulties, memory loss, and degeneration in mental health.
These symptoms can be managed initially with medication but there is currently no long-term treatment that prevents the progression of the disease.
The intermittent drug delivery system
Renishaw’s award-winning device is comprised of up to four catheters which are implanted into relevant areas in the brain. 3D printed titanium transcutaneous ports are implanted behind the patient’s ear, allowing medical professionals to access the catheters. Drug-filled infusion lines are then connected using MRI-compatible components and retractable needles are extended through a septum to allow therapeutics in the external infusion lines to be infused through the catheters.
The patented design allows patients to receive medication in an out-patient setting, where new catheters do not need to be re-implanted with every infusion.
The study
The study was the first of its kind to be trialed with humans, where 17 patients were randomized to either receive placebos for six months or one dose of CDNF every month for six months. After the six months, patients may enter into a secondary study where everyone is given CDNF with Renishaw’s device.
Researchers evaluated the safety and performance of both the device and CDNF. This was done by rating the patients against theUnited Parkinson’s Disease Rating Scale (UPDRS)电机评分评估。该研究的长期性质允许长时间的治疗窗口。这对于评估CDNF的神经保护性和神经训练能力至关重要。
While initial results are promising, researchers will continue to assess the data and add to it the results of the secondary study to form a more complete conclusion.
Rupert Jones, Managing Director of Renishaw Medical, stated: “The results of this trial and the performance of Renishaw’s drug delivery system are promising for the many people with Parkinson’s disease and I would like to take this opportunity to thank the trial participants for making this possible.”
他补充说：“这些结果使我们能够建立Renishaw设备的CE标记，以便进一步的神经退行性和神经肿瘤学条件可以从我们的技术中受益。我们将我们的设备视为一种有能力的技术，可促进直接将治疗剂传递到实质内深处的靶标，这是神经系统疾病和脑肿瘤的治疗方式的范式转移的一部分。”
The study received funding from the European Union’s research and innovation program Horizon 2020.
这已经不是第一次3 dprinting technology has been used in medical implants. In South Africa,surgeons completed a landmark ear operation using 3D printed titaniumto reconstruct parts of an ear. Elsewhere, in Germany, clinical trials focused on3D printed breast implantshave commenced.
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Featured image shows Renishaw’s drug delivery device. Image via Renishaw.
