A group of researchers advised by Harvard scientists has created an implant which can be electrically stimulated to release drug doses through a specially designed microchip, lessening the hassle of treatment for patients requiring daily injections.
The implant, which could accommodate 20 drug doses, was inserted under the skin of the waist of eight women afflicted with osteoporosis, a disease that reduces bone mineral density.
Harvard Medical School professor Robert M. Neer, who advised researchers in the process of creating the implant, said that it took nearly a decade to safely seal the drug in a single dose reservoir.
“The company went to extraordinary lengths to make sure that all the reservoirs would not empty simultaneously,” Neer said.
Researchers monitored blood markers to determine how effectively the implant dispensed Teriparatide, a commercially manufactured form of the parathyroid hormone which increases the amount of calcium in the blood and promotes bone formation. According to the study published in Science Tranlational Medicine this month, they found that the drug was delivered as effectively through the implant as through injections.
Robert Farra, President and Chief Operating Officer of MicroCHIPS, Inc., the private company that funded this study, said that they carefully monitored the chemical activity of both the implant and the Teriparatide injection and then compared the results.
“We found that the implant had a similar therapeutic efficacy as the subcutaneous injection,” Farra said. “There was also less variation in the pharmacokinetic parameters of different doses with the implant.”
Researchers also checked that the device could be filled with appropriate dosages, that the drug could be released within a specified time frame, and that it could stay stable at body temperature.
After conducting preliminary trials on dogs, researchers made significant changes to the device design in order to be cleared for human clinical trials.
During the human trials, patients did not experience any infections or complications due to the implant, and many said that they could not even feel its presence.
“Right after we implanted the device, patients were able to get up and walk out,” Farra said.
Currently, scientists are working on designing a device that can administer 365 doses, enough to last for a year. Researchers are also considering the possibility of using the implant for patients with other diseases such as multiple sclerosis.
“The day-to-day routine that patients go through is difficult and becomes a hardship that they are burdened with,” said Farra. “This technology truly allows patients to no longer worry about their disease.”
—Staff writer Michelle Denise L. Ferreol can be reached at mferreol@college.harvard.edu.
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