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DARPA is developing an implantable device with bioengineered cells for treating everything from traveler’s diarrhea to jet lag.

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Dec 28, 2021, 5:32:15 PM12/28/21
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https://neo.life/2021/07/living-pharmacies-could-remedy-disrupted-sleep/



DARPA is developing an implantable device with bioengineered cells for
treating everything from traveler’s diarrhea to jet lag.

By Emma Yasinski



multimillion-dollar program from the U.S. military’s Defense Advanced
Research Projects Agency (DARPA) is seeking to develop an “internal
pharmacy” in the form of an implantable device containing a set of
bioengineered cells and a small LED light that would trigger the release
of specific biomolecules on demand to counter the effects of jet lag and
traveler’s diarrhea—two conditions that can seriously impede soldiers’
health and performance.

“The program is trying to give the war fighter a way to control her or
his physiology so that they can perform to the best of their ability, to
stay healthy and alive,” says Paul Sheehan, who’s managing the project
at DARPA, which announced $33 million in grant funding for a new
Advanced Acclimation and Protection Tool for Environmental Readiness
(ADAPTER) program in May.

If it works, scientists think the technique could help all kinds of
people who have to adjust to different sleep schedules—people like
graveyard-shift workers or people who regularly take medications for
chronic illnesses that disrupt their sleep.
Jet lagging behind

The immediate danger of sleep deprivation on personnel is as obvious in
the military as it is in civilian life. Sleepy people make mistakes.
Service members who reported sleep deprivation were far more likely to
be involved in vehicular accidents or sustain other injuries than those
who didn’t. Outside the military, when doctors in residency programs
worked continuous shifts longer than 24 hours, medical errors increased
36 percent and diagnostic errors ballooned more than five-fold. Nurses
working night shifts experience similar challenges.

Traveling far during a deployment can severely impact a soldier’s
performance by disrupting their sleep schedule as they acclimate to a
new time zone. Of course, some pharmaceuticals already exist, but
sleeping pills like Ambien can cause side effects like confusion and
irregular heartbeats or just leave the users groggy the next day. Your
body can only adjust about one hour per night. “So if you’re traveling
eight time zones or shifting your schedule by eight hours, it would take
you over a week to adjust to that,” says Jonathan Rivnay, an engineer at
Northwestern University leading the DARPA project. He adds that options
like melatonin can help, but only minimally. The supplement only shifts
your sleep cycle one direction, making you fall asleep a little earlier,
“so [whether or not they’re helpful at all] depends on your direction of
travel.”

Making the most of melatonin is one aspect of the ADAPTER program, and a
group of grant recipients at Stanford University will work to create an
implantable device to release the supplement regularly, to help you
start falling asleep earlier so your body can start to adjust to a new
time zone before you travel. One of the supplement’s limitations is that
soldiers have to be sure to take it at the optimal time for it to work.
“You can imagine an individual who’s engaged in combat maybe is not
thinking about their sleep when they’re on active duty,” says Kimberly
Fenn, a circadian rhythm researcher at the Michigan State University who
is not involved in the project.

The circadian rhythm is the “master clock” that regulates cellular and
molecular function in our bodies around a 24-hour cycle. While the
rhythm responds to cues from natural light and is frequently associated
with sleep and wakefulness, the cycle does more than regulate somnolence.

When we think about time zone and travel, “we often think about the
disruption to your sleep, but it also affects essentially all of your
underlying physiology. Every cell in your body fluctuates on this
24-hour rhythm,” so if you travel to a time zone six hours ahead of your
current time zone, it’s not just the cells involved in sleep that need
to adjust. “Essentially every cell in your body needs to shift these six
hours,” says Fenn. Forcing those cells to shift their functioning can
cause long-term problems. “If you just take a rat and make it shift [its
sleep cycle] six hours every week, those rats die earlier than if they
don’t have to shift.”

Research involving people who engage in shift work, such as nurses, has
shown that it can lead to all sorts of health problems, says Fenn,
“including higher rates of obesity, high rates of diabetes, higher rates
of cardiac issues, heart attacks, high blood pressure.”

The military wants to do more than help soldiers sleep a bit easier. It
wants to make their whole physiology better. Rivnay explains that, “you
might be shifted to the light, dark cycle, but your feed cycle is not
shifting accordingly. And so now you have this mismatch in the various
performance and health issues.”
How it would work

Researchers believe that 60 percent of service members sleep less than
six hours per night.

The military has been investing in research to improve sleep. Proposed
solutions include “tactical naps” and transcranial electrical
stimulation—electrically stimulating neurons through a swim-cap-style
hat or headband—aimed at helping soldiers fall into a deep sleep faster.

The new DARPA project looks to develop something far more sophisticated
over the next four and a half years by creating and testing the wireless
ADAPTER device containing cells engineered to release certain proteins
that could modulate your circadian rhythm in response to an embedded LED
light that users could program with the push of a few buttons on their
smartphones. The light would turn on and off according to the schedule
you’ve set, stimulate the production of the necessary molecules
precisely when you need them, and you would be able to change your dose
by adjusting the intensity or duration of the light, says Rivnay. Since
the cells could produce the molecules, you’d never have to “refill”
them. In order to keep the cells alive, the researchers plan to develop
a membrane to house them, which will allow for the exchange of oxygen
and other nutrients while guarding against immune cells that could
attack the cells in the living pharmacy.


The technology of engineering cells to respond to light, called
optogenetics, has already been used to control all kinds of cells in
animals to study processes like addiction. “Anything that your cells can
produce, you can theoretically engineer cells to produce on demand,”
says Rivnay.

Over the past several years optogenetics has given scientists the
incredible ability to control cells in living animals. Using the
technique to manipulate cellular activity has led to major insights into
both biology and behavior. Scientists have also used optogenetic
neurons, for example, to create cellular electrodes that could act like
wires into the brain to electrically stimulate neurons to function.
These wires mimic metal electrodes currently used in deep brain
stimulation—a procedure in which the metal electrode is implanted into a
patient’s brain where it stimulates cells to produce dopamine to treat
Parkinson’s disease.

He declined to specify which molecules the cells he’s working on will
release, but he says they are testing several, all of which were chosen
because they’ve been studied in Petri dishes or animal models. The team
hopes that with a bevy of different molecules, an internal pharmacy will
be able to control multiple aspects of a person’s circadian rhythm and
have a larger impact than just adjusting sleep. In the first phase of
the project, one goal is to be able to line up sleep cycles with
feeding-fasting cycles, for instance. “The big question mark is whether
the biomolecules we’re choosing will have the intended shifting effect,”
Rivnay says.

The second engineering hurdle will be in finding ways to integrate those
cells into the living pharmacy devices they’ve imagined. Sheehan
emphasizes that, of course, nothing will be given to a soldier before
it’s been approved by the U.S. Food and Drug Administration (FDA).

In addition to being able to stimulate the production of certain
molecules within the body with a beam of light, the team hopes to make
the technology programmable, explains Sheehan. If, for example, you know
that three days from today, you’re being deployed to a location six
times zones away from where you are now, you can program that into the
device and initiate therapy in advance. The “pharmacy” would start to
release molecules to help you adjust to the time zone change, basically
having your body travel in that direction before you even got on the
plane, he says.

This could make taking certain drugs for chronic illnesses a
passive action that people would no longer have to think or worry about.

A similar technique would be used to battle traveler’s diarrhea. A team
at MIT is developing a programmable device that could be swallowed
before traveling. If a solider traveling to a place where the food or
water might contain unfamiliar pathogens, he or she would swallow the
pill-like device, which would release a prophylactic non-antibiotic
therapy every few hours. Currently, soldiers would have to wait for
symptoms to arise, then be prescribed antibiotic treatments.

This wouldn’t be the first pill connected to a cell phone. Scientists
have previously designed a swallowed pill that temporarily monitors
conditions in your digestive tract and sends information to a cell phone
or computer as it travels through your digestive system. But in that
case, the pills only send information about the presence of medication
in the stomach—the user cannot trigger them to release medication of
their own.
Beyond the soldiers

The stated purpose of the program is to help soldiers perform optimally,
but the researchers involved are enthusiastic that the project’s
findings could have implications for all fields of medicine. An
implantable device like this could make taking certain drugs for chronic
illnesses a passive action that people would no longer have to think or
worry about. It could optimize the timing of doses and prevent any from
being missed.

Additionally, there’s an entire field of science called
chronotherapy—the study of how delivering treatments at different times
can affect their outcomes—that suggests widely different health outcomes
based solely on when people take prescribed drugs. This device could be
the ultimate chronotherapy tool by programming it to deliver therapies
at exactly the right time, even when a person is sleeping.

“The classic example is for cancer,” says Sheehan. “It is known that the
best time to give many cancer treatments is when patients are asleep,”
because the treatments target rapidly dividing cells. When the patient
is asleep, many healthy cells that divide rapidly when they’re awake
take a break, so giving the therapy while the patient sleeps could
reduce its side effects. “But that doesn’t fit in with when the doctors
and the nurses are available.”

For someone who needs insulin to control diabetes, the device could act
as an insulin factory that never needs to be refilled or replaced,
explains Rivnay.

“The implications of an implantable device that can deliver therapy on
demand are huge,” says Sheehan.
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