Much as anyone with a medical condition wants to get better, it can often be difficult to get patients to stick to their medication regimens. This is particularly true for patients who are required to give themselves injections - a time-consuming and unpleasant procedure that it's easy to "forget" to do. Scientists from MIT and Massachusetts-based company MicroCHIPS Inc., however, have come up with what could be a solution. Yesterday, they announced success in the first clinical trial of an implantable chip-based device, that automatically delivered regular doses of medication to osteoporosis sufferers.
MIT professors Robert Langer and Michael Cima began work on the technology about 15 years ago, which led to the formation of MicroCHIPS, which has been developing the technology.
In the trial, the programmable chips were each loaded with 20 doses of the osteoporosis drug teriparatide, each dose sealed within its own pinprick-sized reservoir. Each of those reservoirs was capped with a mixture of platinum and titanium (or gold), which melted when an electrical current was applied from an integrated battery - thus releasing the drug into the body. The devices are capable of following a preprogrammed medication schedule, although they can also be manually triggered via radio communication over a select frequency. In this way, doctors could remotely adjust a patient's dosage, if needed.
The clinical trial took place in Denmark last January. Seven women aged 65 to 70 received the implants subcutaneously, just below the waistline. The 30-minute procedure was performed under local anesthetic. The women then proceeded to go about their lives as usual for the next four months, the chips providing them with regular doses of teriparatide throughout that time. The researchers proceeded to monitor the condition of the test subjects for a period of one year.
Not only did the implants prove to be safe, but the patients reportedly often forgot that they were even there. Bone formation caused by the medication was found to be similar to that occurring in patients that received daily injections of the drug, plus there was less variation in the dosages delivered by the chip.
The scientists are now working on a chip that could contain up to 400 doses, and are looking towards subjecting it to human trials. They state that the technology could be used to treat a variety of conditions, and that one chip could carry and release multiple types of drugs - a lifetime's worth of vaccinations could theoretically even be contained in a single device. MicroCHIPS has also developed a glucose level-monitoring sensor, which could be incorporated into one of the chips, causing it to release medication in response to changes in the patient's condition.
The company is planning on filing for regulatory approval of the chip-based drug delivery implant in 2014. It could be commercially available for osteoporosis treatment in five years.
A paper on the research was published yesterday in the journal Science Translational Medicine.