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Johnson & Johnson, ViaCyte testing possible diabetes cure


    ViaCyte’s Encaptra delivery system, placed next to a quarter to give a size perspective.

Johnson & Johnson, continuing its long quest for a Type 1 diabetes cure, is joining forces with biotech company ViaCyte to speed development of the first stem cell treatment that could fix the life-threatening hormonal disorder.

They’ve already begun testing it in a small number of diabetic patients. If it works as well in patients as it has in animals, it would amount to a cure, ending the need for frequent insulin injections and blood sugar testing.

ViaCyte and Johnson & Johnson’s Janssen BetaLogics group said Thursday they’ve agreed to combine their knowledge and hundreds of patents on their research under ViaCyte, a longtime J&J partner focused on regenerative medicine.

The therapy involves inducing embryonic stem cells in a lab dish to turn into insulin-producing cells, then putting them inside a small capsule that is implanted under the skin. The capsule protects the cells from the immune system, which otherwise would attack them as invaders — a roadblock that has stymied other research projects.

Researchers at universities and other drug companies also are working toward a diabetes cure, using various strategies. But according to ViaCyte and others, this treatment is the first tested in patients.

If the project succeeds, the product could be available in several years for Type 1 diabetes patients and down the road could also treat insulin-using Type 2 diabetics.

“This one is potentially the real deal,” said Dr. Tom Donner, director of the diabetes center at Johns Hopkins University School of Medicine. “It’s like making a new pancreas that makes all the hormones” needed to control blood sugar.

Donner, who is not involved in the research, said if the device gives patients normal insulin levels, “it’s going to prevent millions of diabetics from getting dangerous complications.”

People with Type 1 diabetes no longer produce insulin, the hormone that converts sugar in the blood into energy, because their immune system has killed off the beta cells in the pancreas. Those cells make insulin in response to rising blood sugar levels after a meal.

Over years, excess sugar in the bloodstream damages blood vessels and organs. Without effective treatment, diabetics suffer severe complications: blindness, kidney failure, heart disease, amputations, even premature death. On the other hand, too much insulin can cause very low blood sugar, which can kill patients, particularly young children.

According to the American Diabetes Association, about 29.1 million Americans have diabetes, including 1.25 million with type 1 diabetes. The number with Type 1, or insulin-dependent, diabetes is growing steadily. Meanwhile, the number with Type 2 diabetes, whose bodies make some insulin but don’t use it efficiently, is increasing exponentially due to the global epidemic of obesity and sedentary lifestyles.

Many patients can’t control it well because treatment is exhausting, requiring a strict diet, frequent exercise, multiple daily insulin injections or other medicines and several finger pricks a day to test blood sugar. Also, some patients can’t afford the expensive medicines.

ViaCyte Inc., based in San Diego, has been researching its treatment for a decade, partly with funding from the Juvenile Diabetes Research Fund and the California Institute for Regenerative Medicine.

Johnson & Johnson, based in New Brunswick, New Jersey, is a major ViaCyte investor and has been conducting parallel research for about 13 years, said Diego Miralles, J&J’s head of global innovation.

“We wanted to hedge our bets to make sure we would win in this space … that is so transformational,” Miralles said.

He wouldn’t disclose financial terms of the deal with ViaCyte.

The privately held company began the first round of patient testing a year ago, implanting its product, dubbed VC-01, in a dozen people with Type 1 diabetes, said Paul Laikind, ViaCyte’s CEO and president. They received a small dose of insulin-producing cells inside their devices and are being closely monitored for two years to see insulin production and other effects.

After 12 weeks, the device had properly attached to nearby blood vessels, their new insulin-producing cells were still multiplying and no side effects were seen. Another dozen planned patients will soon get the same cell dose in capsules to be implanted in them.

If that goes well, in the next round of testing a few dozen patients will get devices holding a full dose of the cells implanted, likely in the second half of this year. Further testing may be needed before the product can be approved by regulators.

“We do believe that it will need to be replaced periodically,” Laikind said.

Earlier testing in thousands of mice over years showed the lab-created insulin-producing cells matured and produced the needed hormone inside the mice for as long as they lived, about a year, noted Laikind.

Because of the protective capsule, which is flattish and smaller than a business card, if something goes awry, the capsule can be removed immediately to prevent patient harm.

Dr. Betul Hatipoglu, an endocrinologist at Cleveland Clinic, wrote in an email that preliminary results on the device are promising.

“More research is needed to continue to understand its impact,” she wrote, adding that researchers must fine tune the device and determine whether there are any unforeseen safety issues.

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  • It’s amazing that a device only about an inch by 1/2 inch can contain enough beta cells to produce sufficient insulin to control blood sugar in an adult human.

  • Why is it that the media (and the medical community!) continue to blame “obesity” as a “cause” of diabetes? Let’s get this straight and place the blame where it belongs. Obesity and diabetes are both OUTCOMES of bad nutrition – one does not cause the other. The medical community persists in denying that nutrition is a fundamental factor for health. Our culture is so in love with trash food produced in factories and factory farms that it’s become the norm, and real natural food is viewed as a crackpot idea for hippies! Many/most medical professionals still deny that healthy eating is a better cure for many diseases than pharmaceuticals. There are many documented cases of diabetes disappearing in patients who embrace the right diet, and yet we are still looking to Big Pharma to cure everything we do to ourselves. We have to face up to the fact that two scoop rice, one scoop mac salad, and “juice” that’s 20% sugar and 80% water are killing us and we have to take personal responsibility for change.

    • I agree with you, however it is difficult to change the ever changing habits of the general population. My personal fitness routine (habit) takes a certain level of commitment but doable. I attempt to combine cardio, strength, stretching and specific spatial recognition exercises (balance) three times a week (1 1/2 hours) and walk 18 holes once a week. Dieting and portion control runs parallel to all of this. Some of life’s indulgences are still permissible…with moderation. Bottom line…it will come to an education decision by the individual.

    • Great post! Type 2 diabetes can certainly be controlled in most cases by changing a destructive diet, but type 1 unfortunately is not diet related, so this is good news for those patients.

      • Fat (good and bad) is the culprit in T2 diabetes (of which I’m curing myself of). Unfortunately, the corporate food profit mongers know that and use our bodies natural drive for high calorie foods against us. What we need is more nutritional education in our schools. Big Food is trying to head off education by flooding our schools with bad food to hook our kids early.

        • Confused. If you know that eating corporate food (your words) is bad for you, why do you eat them? No one is forcing you to indulge as there are plenty of wholesome food out there for you. Isn’t the real problem “discipline”?

    • MW Hula, I completely agree. The key is nutrition and education. Part of the problem is the way we view food and “food.” People need to view food, real healthy, wholesome food as medicine and vital to their health. The junk served up as “food”…junk food, chips, fast food,trash food, unpronounceable ingredients in a jar, bag,bottle and plastic needs to be viewed as poison. If more people started to grow some of their own food, they would see and taste the difference.

  • What we are seeing are clinical and approvals that are being allowed to move forward, in my opinion, in a reasonable and expedient manner. Diabetes (regardless of how you got there) is a global medical issue and this would may be beneficial for many. I am pleased that J&J Janssen (developed Imodium years ago) is working with and ViaCyte on these clinicals in addition John Hopkins. Regarding smoother processing of clinical and approvals, there are also a couple of pre-existing drugs (indications for stroke and epilepsy treatment) that are being are in clinical studies one in Japan (beginning this year) and one in the U.S. (last phase 2016) for “treatment” of mild cognitive impairment (MCI) that is has been determined a contributor to dementia. These drugs will basically help keep brain activity network intact…very interesting.

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