Scientists at medical technology developer MicroCHIPS in Walthan, Massachusetts and MIT reported the results of a successful human clinical trial of a programmable and wirelessly controlled implanted microchip to deliver drugs. The results appear online in the journal Science Translational Medicine (paid subscription required).
The trial, the first successful test of this type of device, was funded and supervised by MicroCHIPS. In the test, the programmable chip implants delivered the osteoporosis drug teriparatide to seven women aged 65 to 70.
MicroCHIPS says the interactions between the treatments of the body of the patients in the trial showed the combination of drug and implanted device were comparable to the recommended repeated injections of teriparatide. The study demonstrated that the programmable implant was able to deliver the drug at scheduled intervals and with less variation than the injections. Indicators of the drug’s effectiveness — biological markers of bone formation and resorption — were shown to be similar to those reported in previous studies with daily injections of teriparatide.
The human clinical trial began in Denmark in January 2011. The microchip device was implanted in a 30-minute procedure and removed using a local anesthetic. Patients say that the microchip device that remained implanted for four months was well-tolerated, and that they would repeat the implant procedure. The trial reported no toxic or adverse events due to the device or drug.
The development of a microchip device for drug delivery began at MIT in the mid-1990s by then-undergrad John Santini, under the direction of biomedical engineering professors Robert Langer and Michael Cima. Santini — now a graduate student at MIT — Langer, and Cima are among the paper’s authors.
MicroCHIPs licensed the technology from MIT in 1999 for further development and commercialization. The company’s refinements of the chips include adding a hermetic seal and a release system that works reliably in living tissue. In the study, the chips stored 20 doses of teriparatide, individually sealed in chambers about the size of a pinprick, and capped with a thin layer of platinum and titanium. That protective layer melted away when a small electrical current is applied, releasing the drug inside.
The device is programmable, which enables dosages to be determined in advance and personalized for the patient. The device can also be triggered remotely using the medical implant communications service protocol, a low power, unlicensed, mobile radio service for transmitting data used with diagnostic or therapeutic functions of implanted medical devices.
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