Renishaw's neuroinfuse device.
Renishaw's neuroinfuse drug delivery device.
Renishaw’s 3D printing-enabled neuroinfuse drug delivery device has again been successfully deployed in a clinical trial of a medication designed to treat Parkinson’s.
Teaming up with Herantis Pharma, the neuroinfuse systems was used to deliver cerebral dopamine neurotrophic factor (CDNF) to more than a dozen patients in a two-part 12-month study. It comes after the same drug delivery device, which is made up of an additively manufactured titanium port and four catheters that are placed into the brain’s putamen, was used to deliver GDNF (glial cell line-derived neurotrophic factor) to more than 40 patients in a trial carried out by North Bristol NHS Trust.
This latest trial was led by Herantis Pharma and was split into two segments of six months. In the first, around half of an original 17 participants were infused once a month with CDNF, while the other half were given a placebo, and in the second, the remaining 15 participants were all treated with six CDNF infusions.
During the clinical trial, each patient underwent an initial surgery to implant the 3D printed titanium port into the side of their head. The port has been machined post-print to leave a smooth and polished finish on the top side of the port, which sticks out of the skin to allow an accessory to be attached when infusing the drug, and a roughened finish on the implanted end to encourage skin and bone integration. During the implantation, surgeons use MRI scanning images to precisely place the four catheters into the putamen and avoid blood vessels.
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Each of the CDNF drug, Renishaw’s neuroinfuse device and the surgical procedures were being evaluated during this 12-month trial. Initial results indicated predictable and accurate placement of the device and there were no serious adverse events considered to have device or drug causality. Meanwhile, the ability to deliver repeated infusions continued to facilitate the assessment of CDNF’s safety and early efficacy.
“Now the extension study has reached its completion, I would once again like to extend a huge thank you to the trial participants for making this study possible, making personal sacrifices that will ultimately benefit fellow and future Parkinson’s Disease patients,” commented Rupert Jones, Managing Director of Renishaw Neuro Solutions. “I'm delighted to see Renishaw’s drug delivery system continuing to facilitate repeated infusions over an extended period of time for such a complex condition as Parkinson’s Disease.
“The device’s performance demonstrates what a powerful delivery platform it is for the treatment of many, currently incurable, neurological conditions, opening new possibilities in the field of neurosurgery and neuroscience. I see this as a hugely positive step forward and believe all involved in the study should be proud of their achievements.”
