We R the Cure

Seeking Cures and Cheating Destiny


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JDRF Research News: Specific Protein May Help Beta Cells Survive in Type 1 Diabetes

JDRF-funded researchers find therapeutic potential of MANF protein to reduce beta cell stress in type 1 diabetes.

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I am a diabetes advocate. We R the Cure is a blog site dedicated to the persons living with Type 1 diabetes and the clincial researchers who are making positive things happen in our journey to a cure.

In the healthy pancreas of someone without type 1 diabetes (T1D), the hormone insulin (essential for turning food into energy) is produced, stored, and released in a normal “factory-like” process within pancreatic beta cells in response to glucose in the diet.

Early in the course of T1D, however, excessive or pathologic stress in beta cells compromises their ability to properly secrete insulin, triggering a cascade of events ultimately contributing to the beta cell death. Over the past several years, JDRF-funded researchers have found evidence that beta cell stress may play a role in the onset of T1D, and are exploring possible ways to stop it from occurring, thus potentially protecting beta cell health and maintaining normal beta cell function.

In April, JDRF-funded researchers in Finland released new findings in the journal CellPress that add another piece to the puzzle of beta cell stress and T1D.

Post comes from News release published at  http://www.jdrf.org.


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Turning Type 1 Diabetes into Type None: I’m wearing biker shorts (Ugh) and riding for a cure

Hello Friends and Supporters of Type 1 Diabetes research!

JDRF Ride to Cure Diabetes

Why do we ride? We ride to raise research funds so that Daniel Majikes, left, has hope for a brighter future and a real cure for Type 1 diabetes. Daniel and I will ride together in Vermont on July 26.

I’m taking part in the JDRF Ride to Cure Diabetes in Vermont this July, along with hundreds of riders from around the world, to raise money for JDRF, the leading global organization funding type 1 diabetes (T1D) research. My training is designed so I can ride up to 100 miles on a bike — I’m not a cyclist but I am a biker with a mission.

So far, I’m up to 29 miles of weekly bike training and heading toward a busy July riding the back roads of Goochland County — which is a beautiful area to ride. As Jackson Browne sings, “Looking at the road rushing under my wheels … Running on Empty … but I’m running on.”

Click here to visit my personal page.

I received my Type 1D diagnosis — from out of nowhere — in May 1998. That is 16 years this May 2014. It’s been a real up-and-down journey since that unfortunate starting line when my fasting blood sugar was 500+ as I sat in the exam room at Chester Family Physicians.

Today, 16 years later, I count only my blessings for all the good things that have happened to me on my journey to a cure. It’s the Type 1D people — Drew, Lauri, Daniel, Linda, Matthew, William, Susan, Fred, Tony, Kevin, Patti, Trish, Shea, Sarah, JP, Liesl, Molly, Mary, Laura, Boris, Danny, Sue, Stacy, Nicole, Kathy, Ned, Chris, Eva, Cecil, Cheryl, Larry, Melanie, Kim, Hillary, Doran, McKenzie, Sandra, Connie, Kailee, Nathan, Tom, Kim, Tiffany, Andrew and all my fellow JDRF volunteers too numerous to list — that’s why we ride.

We do ALL this for each other. We do it for ourselves. We do it for our friends and loved ones. We do it for my aunt Mary Jane, a Joslin Medalist who’s lived with Type 1 Diabetes for 70+ years and is still kicking – despite having both feet amputated due to diabetes complications. And we do it for the next generation of children and adults who have not been diagnosed yet.

Today, I’m making my biggest commitment yet. I have joined Coach Matthew Majikes and the Central Virginia Ride to Cure Diabetes team. Our goal is simple: To train together as a team, enjoy our time together, and cycle up to 100 miles in Burlington, Vermont July 24-27 to raise awareness and dollars for research that will improve the quality of life for children, teens and adults living with this chronic disease.  And one day soon — our efforts will generate a quality of life cure like the Artificial Pancreas and the ultimate goal, a medical cure that reverses or stops Type 1 diabetes in its tracks.

Will you help me on my road to a cure?

JDRF is working every day to fund critical diabetes research. And every dollar I raise helps them continue to bring life-changing therapies from the lab to the community until a cure is found. I’m  entering my second month of training on my bike. Please check back to view my fundraising progress as my Ride weekend approaches.

Can you make a donation of $25, $30 or more today? Your support, both financially and emotionally, is greatly appreciated. Please consider making an online donation today. Thank you. Together, We Are The Cure.

Mike Anderson

Click here to visit my personal page.


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D-Blogweek Post 2: He’s a poet and don’t know it — For Whom the Bell Tolls

Yesterday was Poetry Day for Diabetes Blog Week. So, I’m playing catchup already.

Click on the #Dblogweek buttoin

Diabetes Blog Week — Click to find out more details.

Instead of  trying to be a poet, I think it’s wiser to reprint something that fits a certain viewpoint — how Type 1s are living with a chronic disease that ticks, ticks, ticks in the back of our mind. Healthy looking on the outside, not so healthy on the inside.  Seeking Cures and Cheating our Destiny.  And raging against the machine.

No man is an island,
Entire of itself.
Each is a piece of the continent,
A part of the main.
If a clod be washed away by the sea,
Europe is the less.
As well as if a promontory were.
As well as if a manor of thine own
Or of thine friend’s were.
Each man’s death diminishes me,
For I am involved in mankind.
Therefore, send not to know
For whom the bell tolls,
It tolls for thee.

These famous words by John Donne were not originally written as a poem – the passage is taken from the 1624 Meditation 17, from Devotions Upon Emergent Occasions and is prose. The words of the original passage are as follows:

John Donne
Meditation 17
Devotions upon Emergent Occasions

“No man is an iland, intire of it selfe; every man is a peece of the Continent, a part of the maine; if a clod bee washed away by the Sea, Europe is the lesse, as well as if a Promontorie were, as well as if a Mannor of thy friends or of thine owne were; any mans death diminishes me, because I am involved in Mankinde; And therefore never send to know for whom the bell tolls; It tolls for thee….”


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D-Blog Week is back in 2014; Goal is to connect, share our hopes, and change the Diabetes World

For the 5th year in a row, diabetes online writers from all over the world will be participating in a solid week’s worth of informative, educational, and inspirational blog posts. To find out everything you need to know about Diabetes Blog Week, click on the button to the right.

Click on the #Dblogweek buttoin

Diabetes Blog Week — Click to find out more details.

Can you join a blog party that’s already been going on for 5 years?

Yes, I’m going to jump in for the first time ever this week. That’s 7 blog posts in 7 days. OMG.  Let’s get the party started.

Today’s topic: Change the World – Monday 5/12

Let’s kick off Diabetes Blog Week by talking about the diabetes causes and issues that really get us fired up. Are you passionate about 504 plans and school safety? Do diabetes misconceptions irk you? Do you fight for CGM coverage for Medicare patients, SDP funding, or test strip accuracy? Do you work hard at creating diabetes connections and bringing support? Whether or not you “formally” advocate for any cause, share the issues that are important to you. (Thanks go out to Kim of Texting my Pancreas for inspiring this topic.)

Changing the world?

A few years ago, I won’t say how many, a very “Zen” co-worker of mine was fond of quoting inspirational slogans to inspire team members to overcome our every day, routine work challenges. At the time, my personal guru was a very non-Zen spiritual leader named Vince Lombardi, legendary head coach of my Super Bowl champion Green Bay Packers.

Needless to say, we didn’t have a lot in common. Funny thing, two decades later — after spending many days, weeks, months  and years working with volunteers at the local and state level to raise awareness and the critical funds for Type 1 diabetes research — I can admit it: My co-worker was right in sharing his quotes with us. With a shout out to my former colleague, Karl Bren, here’s the quote that fits perfectly with the diabetes online community (DOC) perspective:

“Never believe that a few caring people can’t change the world. For indeed that’s all who ever have. ”
Margaret Mead, The World Ahead: An Anthropologist Anticipates the Future    

So, if the Genie stopped by today and granted me 3 practical — not magical — wishes to change the diabetes world — here’s what I’d want to make happen:

  1. Remove the FDA’s ability to delay or drag its bureaucratic feet — to block cutting-edge insulin pump technology that is being used successfully in Europe.  Bring it to the USA. Now.
  2. Remove roadblocks so we can expand the research and exploration into stem cells and regeneration technology like the efforts now underway in California by ViaCyte. Let’s “wake up our unemployed pancreas” and bring it back to full employment producing beta cells and the insulin we need ON Command. (A related side wish — Bring back the missing limbs, bring sight back to the blind, and restore full health to the persons who’ve lived with Type 1 diabetes for decades and lost a few rounds with the killer. This one’s for you, Aunt Mary Jane!)
  3. Ask everyone to stop blogging, tweeting, snap chatting and every social media form of expression for 1 year — and go visit their next-door neighbor, siblings, family members, strangers and find ways to improve your own piece of the world. What’s your passion? What problems plague your community? If you have diabetes, cancer or any life-threatening disease — see if it makes sense  for you to volunteer for a human clinical trial. Jump in and encourage others to do the same. We need more trials so we can stop curing Mice With Diabetes and focus on Persons With Diabetes.

We are the world, we are the children, We are the ones who make a brighter day, So let’s start giving. There’s a choice we’re making, We’re saving our own lives. It’s true we’ll make a better day, Just you and me … We R the Cure!”

It’s Diabetes Blog Week, and this entry is for the “Change the World” topic.  For more on Diabetes Blog Week, including participants and topics, click on the respective links.  It’s not too late to join in the fun – jump in now!


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Should Type 1 Diabetes Advocates Have Sharp Elbows? Status Quo or Act Up — What is the right pathway?

What does advocacy mean? Is someone who advocates for a cause they believe in — not to be confused with a paid advocate — actually able to make things better, to make change happen at a local, regional or national level? Well, it’s time to find out.

Image for Diabetes Advocates

I am a new member of Diabetes Advocates. Excited to be an advocate. What can we achieve together?

I did not prepare a speech, but I am very honored and excited to have my membership application accepted by the Diabetes Advocates non-profit group. Thank you to the Academy!

The question for me to answer is — how do I actively participate and how do I add my time and voice to the growing chorus of Diabetes Online Community (#DOC) leaders who are real people, not actors on TV, who wake up each day with Type 1 Diabetes and envision a better future for themselves and the next generation of Americans who get this game-changing diagnosis. The DOC has done great things for all of us connected to diabetes.

Are we advocates or practical agitators. Or something in between? The recent article in Insulin Nation about The Juvenile Diabetes Cure Alliance (JDCA) — Practical Cure Advocates — should make all of us stop and think. What change do we advocate for? If we want more human clinical trials, higher-tech technology and a medical cure for Type 1 diabetes — it’s up to us to make it happen.

“Scientists have made careers in proving a concept in mice…we want to push against that gravitational pull” of mouse-only research, Phil Shaw of the JDCA told Insulin Nation.

I’ve been a volunteer and fundraiser for many years with the Juvenile Diabetes Research Foundation — the Central Virginia Chapter. Thru my volunteer work I’ve met some incredible children, teens, adults and selfless parents — and developed friendships with some of the best people I’ve ever met — the people you wish you never had the good fortune to meet. I’ve also been a participant in and an advocate for human clinical trials, and I see how the money raised for Type 1 research does make a difference in our daily lives. However, no matter how hard we all push, we’re still waiting for  better tech, better solutions and a future free from Type 1.

For today, it is my honor to be a new DA and to proudly post the group’s goals. Tomorrow is a new day. Together we are stronger.

Diabetes Advocates is a program of the Diabetes Hands Foundation, a nonprofit organization that brings together people touched by diabetes for positive change so that nobody living with this condition ever feels alone.

Mission
To connect advocates dedicated to improving the lives of people living with diabetes in order to accelerate and amplify their efforts

Goals 2013-2015
1. Continue growing the reach and impact of the program, by:

  • Creating paths for diabetes advocacy for members of the diabetes online community.
  • Increasing the number of Diabetes Advocates members focused on type 2 diabetes.
  • Increasing the number of Spanish-speaking Diabetes Advocates members.
  • Increasing awareness about Diabetes Advocates, starting with an emphasis in the US.

2. Increase the measurable impact of the program through:

  • Increasing member engagement in Diabetes Advocates initiatives.
  • Expanding benefits that impact sustainability and member development.
  • Hosting an annual Diabetes Advocacy Congress.
  • Consolidate Diabetes Advocates as a hub for collaboration among diabetes advocates.


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Mathematics, Mary Tyler Moore and Standard Deviation, Part 2: Looking for the Type 1 Auto Pilot Easy Button

One of the all-time great movie quotes, from Airplane circa 1980s, actually fits perfect for persons living with Type 1 diabetes who keep looking for a qualified pilot or Auto Pilot “Easy Button” to help them fly safe and keep their complex human body on course:

Photo of Auto Pilot Easy Button to push for diabetets control

Managing Type 1 diabetes is like flying a complex jet airplane. What we need is an Auto Pilot Easy Button to keep us flying level and safe.

“All right, Striker, you listen, and listen close. Flying a plane is no different from riding a bicycle; it’s just a lot harder to put baseball cards in the spokes.”

The more you know about your own diabetes, the less you understand. The more time you spend managing your diabetes, using the latest technology tools, aiming for a lower A1c and a lower Standard Deviation, logging in and learning from the Diabetes Online Community (DOC) — the less you actually comprehend about a chronic disease that is, actually, almost impossible to control. There is no Auto Pilot button in the T1D cockpit.

In the first four months of 2014, I’ve been hyper-focused or rededicated to my diabetes management. Thanks to my new tech partner, the Dexcom “Studio” reporting app, I’ve been monitoring my hourly, daily and weekly trends, adjusting basel and bolus rates based on pattern or trend lines,  and charting my own “success report” or flight plan.  Of course, a true “success report” for Type 1Ds would show a TAB that says: “CURED.” Sorry, but I have not found this category yet on the Dexcom app.

If you’re looking for good news, here it is: My quarterly check up in April produced my best A1c number in almost 2 years — a 7.5 A1c! This is down from my 7.8 A1c in January, and my better-than-average result also produced a Standard Deviation number of 51 for April — way, way down from my Feb/March SDs in the high 60s.  I am thrilled with the current trend line and I better understand how hard work, diet and exercise, paying attention to the mathematics of diabetes and some luck produces better blood glucose control and fewer serious medical complications. This cause-and-effect was established in  the landmark DCCT study done more than two decades ago. The Diabetes Control and Complications Trial (DCCT) showed that keeping blood glucose levels as close to normal as possible slows the onset and progression of the eye, kidney, and nerve damage caused by diabetes. In fact, it demonstrated that any sustained lowering of blood glucose, also called blood sugar, helps, even if the person has a history of poor control.

However, here’s where the mathematics, Mary Tyler Moore and standard deviation come back into the story:

How can anyone spend 24/7, 365 days a year — every year for the rest of my life — working this hard at a full-time job that brings with it no pay, no days off, no miracle cures,  and the uncertainty that better blucose control– the goal is under 7.0  A1c — actually reduces medical complications?  As the Mary Tyler Moore TV theme song might actually ask: “You might just make it after all?”

Despite my recent well-earned success, my monthly and quarterly results still show that I’m still spending about 30% of my days ” out of my target” blood glucose zone ( 80 to 170) and, therefore, I still have not achieved true “control”  and may face potential health risks as I age.

Graph showing my Diabetes Glucose Control

My Dexcom Success Report shows better “In Target” results but shows I’ve still got a long way to go to achieve auto glucose control over my Type 1 Diabetes.

Here’s what my flight crew told me this month about my Type 1 Diabetes and how I’m doing on my journey toward better, healthier outcomes.

My Endocrinologist: “I don’t look for a certain standard deviation number, whether that’s 50 or lower. The key is to get the number as low as possible.  Your A1c is moving in the right direction but it needs to be lower.”

My Dietitian — first time I’ve met with one in 10 years. “People with Type 1 have all these numbers running around in their heads. They are constantly thinking about glucose numbers, A1Cs,  carbohydrates and is their trend line going up and down. I think it gets to be a little overwhelming at times. You should give yourself some credit because you are managing things that a person with a normal, functioning pancreas never thinks twice about. My glucose numbers may be the same as yours in a given day, but I don’t spend a minute thinking about it because my pancreas is doing it for me.”

My Dexcom Rep who is also a Type 1 diabetic — “The most important goal is more stable blood sugars. Our goal should be below 50. Even below 40. Our bodies like stability. There is a lot more to diabetes than just controlling one measurement or number. There are so many factors and stress is one of the biggest. If you have a good day and your numbers are improving, that’s a good thing. But some of this is really out of our hands.  We are humans after all.”

I turn to technology to help best manage my diabetes because my pancreas stopped making insulin almost two decades ago, and these advances in treatment have improved my quality of life immeasurably in some ways (emotional health) and very measurably in others (better blood sugar control). The technology we need now is the Auto Pilot Easy Button — or the Artificial Pancreas closed loop system. Push it and it’ll be almost like your pancreas is flying the plane again.


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Ending the A1C Blame Game: Reposting a “Must Read” From MD on Insulin Nation

Research Corner: Ending the A1C Blame Game (via http://www.insulinnation.com)

When glucose sensors first became available in clinical trials some 2 decades ago, I decided to wear a sensor to compare my glucose levels as a non-diabetic individual with glucose levels of my patients. I was excited to have this new tool, which measured…


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Mathematics, Mary Tyler Moore, and Standard Deviation, Oh My! We’re Gonna Make It After All

The headline, I hope, made you stop and wonder. Math. Mary Tyler Moore. Standard Deviation? Three random sounding topics that actually have one thing in common: Living with Type 1 Diabetes, of course.  The balancing act is the perfect excuse to republish some of Mary’s best quotes — about her battle with the disease — on our complicated journey toward better health and cheating our destiny.

We R the Cure blog and photo of Mary Tyler Moore at JDRF Childrens Congress 2009

Mary Tyler Moore greets President Obama during the 2009 JDRF Children’s Congress event in Washington. DC. She is flanked by her husband, Dr. Robert Levine, and boxer Sugar Ray Leonard.

“Both children and adults like me who live with type 1 diabetes need to be mathematicians, physicians, personal trainers, and dietitians all rolled into one,” Mary has told members of the United States Congress during JDRF’s Children’s Congress. “We need to be constantly factoring and adjusting, making frequent finger sticks to check blood sugars, and giving ourselves multiple daily insulin injections just to stay alive.”

I also know that a photo — or in this case a You Tube video from @Blogdiabetes friend Tony Rose — is also worth a 1,000 amazingly insightful words from me, the CEO, Editor-In-Chief of “We R the Cure.com.” Right? As I learned in Journalism 101, it’s time to get to the “So What?” or “hook your audience now” or lose them forever sentence.

After living and dying in three-quarter time with Type 1 diabetes for 15+  years, I’m actually beginning to figure out how much effort, dedication, cool technology and sheer luck it takes to “control” my blood glucose. The answer: It takes every waking second of every day, and that still does not guarantee an A1C less than 7 or eliminate the rollercoaster blood glucose ride. I love coasters, but the more you learn about this crazy,  chronic disease, and the harder you work to control it using insulin pumps, meters, CGMs and Apps — It still winds up controlling you most days.

For the past 4 months, I’ve been religiously wearing my new DexCom 4 Platinum CGM — which I love. And, as the images here will show — my standard deviation has dropped from 68 to 58 and is approaching the 50 reading which, according to Laura Adams, Certified Diabetes Educator with DexCom, is the number persons with type 1 diabetes (PWD) should aim for when seeking to control their glucose. In fact, Laura says a standard deviation reading between 50 and 40 on my DexCom ” Studio” reporting App should be the target. Fortunately, calculating the SD number is done automatically by the App based on my CGM numbers. They’ve taken the math out of my hands.

In Part 2 of this blog story, we’re going to dive deeper into the math and determine if standard deviation, A1C or something called “Glycemic Variability” is the true “gold standard” of BG control?

For now, I’ll leave you with these positive trendlines from DexCom App, which does not sync up with my insulin pump App (Diasend) — but that’s another story. Let’s call this my starting point as I aim for better control with the goal of reducing the possibility of serious health complications such as blindness, heart disease, stroke and amputations. I am in charge of my own cure, and getting better control of my numbers is the key.

The good news: My numbers are getting better thanks to technology, effort and some luck. The sobering news: this is a 24/7 battle and there’s never ever a day off.  Don’t take my word for it, take it from my Type 1 best friend, MTM:

“Chronic disease, like a troublesome relative, is something you can learn to manage but never quite escape,” Mary explains on JDRF.org’s website. “And while each and every person who has type 1 [diabetes] prays for a cure, and would give anything to stop thinking about it for just a year, a month, a week, a day even, the ironic truth is that only when you own it — accept it, embrace it, make it your own — do you start to be free of many of its emotional and physical burdens.”

We’re gonna make it after all. We R the Cure.


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Are You Curious About ViaCyte’s Upcoming T1D Clinical Trials? Here’s More Information

Cross-Section Graphic of Viacyte's VC-01 Encapsulated Delivery System

The VC-01 combination product is expected to be implanted under the skin of the patient through a simple outpatient surgical procedure. The cells are then expected to further differentiate to produce mature pancreatic cells that will synthesize and secrete insulin and other factors, thereby regulating blood glucose, commonly referred to as blood sugar levels.

In the closing paragraph of my last blog post, I tried to strike a balance between hope and realism when describing ViaCyte’s VC-01 combination product and pending clinical trials aimed at a virtual cure for Type 1 diabetes.

The possibility/probability of successful clinical trials makes you anxious, optimistic, and fearful of another big letdown. It also leaves you with lots of questions. So I contacted ViaCyte to say “Thank You” for presenting at the JDRF Research Summit in Bethesda, MD last month  and asked a few follow-ups.  To my delight, I got an email response from a person named “Howard” at the San Diego-based company.

Q: How will you recruit or identify prospects for the upcoming clinical trials?

A: Currently, ViaCyte is still in preclinical development with our diabetes product VC-01; we are not conducting any clinical trials at present.  However, we do anticipate completing the necessary preclinical studies and filing an application with the FDA so as to be able to proceed with human trials sometime later this year.  Note that when the clinical trial starts, ViaCyte will adhere to Good Clinical Practice (GCP) guidelines, which preclude the Sponsor (ViaCyte) from having direct contact between clinical study subjects.

Q: How does the proprietary device ” KNOW” when and how much insulin to release?  Are the stem cells smart enough to automatically ” sense ” the amount of glucose in the body and respond in a measured fashion  just like a healthy pancreas does in non Type 1 Diabetics?

A: Yes, the cells contained in the device are smart enough to know when to secret insulin. Strictly speaking, the cells in the device are not stem cells. They are derived from stem cells but have undergone differentiation to a point where they are no longer considered stem cells. The most current information about our progress and technology can be found on our website.

Q:  Will clinical trial participants be required to take immunosuppressant drugs, and,  if this therapy works, will these drugs be required for the rest of the patient’s life?

A: At the present time we do not anticipate that any immunosuppressive therapy will be required, either during the clinical trial or at any time thereafter.

Q: Is there an age range for eligible human trial participants? If people are interested in the clinical trial or applying, how do they contact ViaCyte?

A: In our first clinical trial we anticipate that the age inclusion range will be from 18 – 55 years. Once clinical trials start, information on the location of clinical study sites will be available online at clinicaltrials.gov, the US government database of current clinical trials. Additionally, information should be available on our website once the trial is closer to launch.

Q: Finally, how will this implantable device actually cure my diabetes?

A: By acting essentially as a replacement endocrine pancreas, the source of insulin and other regulatory hormones produced in our bodies, ViaCyte’s VC-01 combination product has the potential to be a virtual cure for type 1 diabetes. The VC-01 therapy is the combination of:

  • PEC-01 cells: A proprietary pancreatic endoderm cell product derived through directed differentiation of an inexhaustible human embryonic stem cell line, and
  • Encaptra drug delivery system: A proprietary immune-protecting and retrievable encapsulation medical device.


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Encapsulated Cell Therapy Aims to Transform, Cure Type 1 Diabetes? ViaCyte’s Human Clinical Trials Coming In 2014

BETHESDA, MD (March 1, 2014) — Well, there you go again. Getting your hopes up for another possible ” cure” for Type 1 Diabetes. That’s what I told myself as I listened to Dr. Eugene Brandon, Ph.D. — an obviously intelligent scientist who was also able to speak in layman’s language — present his case at the JDRF Research Summit hosted by the Greater Chesapeake & Potomac Chapter of JDRF last Saturday.

As I listened and tried to understand the science behind his talk, it was difficult to stay realistic. If they can implant regenerative cells under the skin and these cells will function like  healthy pancreatic cells, then this crazy idea just might work for some children or adults living with T1Ds. So my next question was: When is the first human clinical trial and how do I sign up? Damn the risks; my time is running out. That’s what went through my mind and probably a few others listening to him speak.

Before I booked my flight to San Diego, I settled down and realized one simple fact: I’m attending a diabetes research summit where “hope” is always the key word. Dr. Brandon,  Director of Strategic Relations & Project Management at San-Diego based ViaCyte, spoke to a full ballroom of  T1Ds and their families at the Bethesda North Marriott during the 4th annual JDRF Research Summit.  Dr. Brandon talked about his company’s VC-01™ combination product. It is a stem cell-derived, cell therapy product that the company believes could transform the way patients with Type 1 diabetes manage their disease.

The product is comprised of pancreatic progenitor cells contained in a proprietary device that is designed to be inserted under the skin.  Upon implant, the product is expected to vascularize as the cells further differentiate to islet-like structures that generate insulin and other expected regulatory factors in response to blood glucose levels, essentially providing patients with a replacement for the cells lost as a result of the disease. The company has reviewed the VC-01™ combination product development plans with regulatory authorities at the US Food and Drug Agency and Health Canada.

By acting essentially as a replacement endocrine pancreas, the source of insulin and other regulatory hormones produced in our bodies, VC-01 combination product has the potential to be a virtual cure for type 1 diabetes. The VC-01 therapy is the combination of:

  • PEC-01 cells: A proprietary pancreatic endoderm cell product derived through directed differentiation of an inexhaustible human embryonic stem cell line, and
  • Encaptra drug delivery system: A proprietary immune-protecting and retrievable encapsulation medical device.

Pending regulatory authority review of its planned application, ViaCyte is planning to initiate clinical development in patients with Type 1 diabetes this year!  As he finished his presentation, Dr. Brandon answered a few of the lingering questions from the optimistic but realistic Type 1 Summit attendees.

The testing has worked in mice. But is it safe for humans?

“By all accounts, it is a stable product. Our testing shows it stays stable for the life of the animal,” Brandon said. “If we can get this biological process to work, we think we can replace the damaged islets.” The company also has developed a process for inserting and removing the implanted device quickly. “Something like this has never been tested in humans before.”

When will human clinical trials begin?

“We think we’ll be in pretty good shape to get this ready and approved by FDA for a first human trial planned in 2014,” Brandon said, adding that his company has already held discussions with the FDA on their proposed timeline. “You don’t want to spring something like this on the FDA.”

What is the lifecycle of the implanted device? 

“That is the million dollar question to be determined in the clinical trial,” Brandon said. “How long will this last if it works?” Because the cells are contained in a ” tea bag” type of container, it is anticipated that the body’s immune system will not strike or reject the foreign object. “Theoretically, these implants could last for many years.  That is the purpose of the clinical trials. We will start learning things that can only be discovered in a human clinical trial.”

At the end of the summit, I left with renewed hope for a cure and the sober realization that this chase for a miracle is nothing new to persons living with all types of deadly diseases. In fact, the JDRF was formed 40+ years ago by parents of children with Type 1 diabetes who were committed to pushing faster to fund a cure.  In seeking a cure, we all jump into the fountain of scientific hope. Compared to the quality of life for diabetics before the discovery of insulin in 1921, Type 1 diabetics are living in a golden age of scientific and technology success. Things are improving at a rapid pace. So we keep chasing the illusion and hope to cheat our destiny for one more hour, for one more day, for one more year. Until there’s a cure … we march on.

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