British engineering company Renishaw has announced a milestone in medical research to help people with Parkinson's disease with progressive neurological disease. The study looked at patented internal drug delivery devices and conducted Phase I and Phase II clinical studies with pharmaceutical company Herantis.
3D printed titanium alloy catheter assembled into an internal drug delivery device
The device uses brain dopamine neurotrophic factor (CDNF) as a treatment for Parkinson's and plays a vital role. The initial results are encouraging, showing that the internal drug delivery device can be placed accurately and the efficacy can be expected, and it can promote the efficacy and safety of CDNF.
Parkinson's disease is a neurodegenerative disease caused by the gradual breakdown of neurons responsible for dopamine synthesis in the brain. The main symptoms include involuntary shaking, muscle stiffness and slowed movements. Non-exercising symptoms include difficulty sleeping, memory loss and mental health deterioration. These symptoms can initially be treated with medication, but there is currently no way to prevent the disease from developing in the long term.
Renishaw 3D printed titanium catheters and implanted into the brain-related areas behind the ears by the hospital. An MRI-compatible component is then used to connect the drug-filled catheter and extend the retractable needle through the septum, so that the medicament in the external infusion line is directly injected into the patient's site through the catheter.
The medicament acts directly on the patient's site
This patented design allows patients to receive medication in an outpatient setting, avoiding the hassle of re-implanting a new catheter with each injection.
The study was first tested in humans, with 17 patients randomly assigned, some receiving placebo for 6 months, and others receiving a monthly dose of CDNF agent for 6 months. After six months, patients can enter the second study, and everyone will receive continuous treatment with the CDNF agent.
Researchers evaluated the safety and efficacy of the device and CDNF, which was performed by performing a joint Parkinson's Disease Rating Scale (UPDRS) exercise assessment on patients. The long-term nature of the study allows the treatment window to be extended, which is critical for assessing the neuroprotective and neurorepairing capabilities of CDNF.
Although the initial results are encouraging, researchers will continue to evaluate the data and add the results of the second study to the data to form more complete conclusions. The research was funded by the EU Research and Innovation Program Horizon 2020.
This is not the first time 3D printing has been used in medical implants. In South Africa, surgeons used 3D printed titanium alloys to reconstruct part of the auricle structure and complete landmark ear surgery. In some parts of Germany, clinical trials for 3D printed breast implants have begun.