We R the Cure

Seeking Cures and Cheating Destiny


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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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Giving Our Kids Roots And The Wings To Fly: I Am No Longer My Son’s Pancreas — Drew Is In Charge

By Lauri Savage
Second in a 2-part Post

Lauri tells a Mom's Story of Sending Her Son to College

Lauri Savage, right, concludes her 2-part series on a parent's fear, hope and joy of giving her son, Drew, the ability to manage his Type 1 diabetes while living on his own.

As I write this post, my son, Drew,  has returned to James Madison University in Harrisonburg, Virginia after his final college spring break.  In about 2 months, he will be a college graduate.

I still remember when we brought him to JMU in the late summer of 2008. I am going to fast forward through my son’s upset stomach on the way to college, our leaving him in his dorm room when he was not feeling very well, and the pain of saying good-bye.

The first week of settling in was challenging for him, as it is for all college freshmen and their parents. However, it became much worse on a Sunday evening.  My son accidentally mixed up his insulin doses, injecting himself with 22 units of humalog, a short-acting insulin, instead of Lantus, a 24-hour slower release insulin.

If you are following this blog, then you know that injecting that much rapid acting insulin is dangerous and scary, as it will lower blood glucose levels too fast.  Luckily, my son realized his mistake and phoned us.  He consumed sugar, ice cream and sweets to balance out the rapid effects of the insulin.  But the insulin was too fast for him.

Ultimately, another resident advisor in his dormitory was called and came to help.  We were on the phone with her, and with Drew’s roommate.  Having the roommate’s cell phone number was a lifesaver, as he stayed in touch with us.  It was necessary to call 911, and our son spent several hours in the hospital emergency room getting his blood sugar stabilized. Although JMU is only two hours away from our home in Richmond, it seems much further when your only child has type 1 diabetes.

While this was not the ideal way to start college life, I always try to find the silver lining.  My son showed maturity and responsibility by knowing when to reach out, calling us to keep us up to date, and ultimately taking care of himself.  He learned early on that he could handle an emergency living on his own.

I think that is a big part of our job as parents of children with diabetes — We must help them transition to adults in charge of their disease.  And we should always be there to support them in the background, because living with diabetes is an ongoing challenge.  Until we find a cure.


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Hello World! Cures Needed For Auto Immune Diseases

Yes, my “unemployed” pancreas and I are headed back to the University of Virginia in 2012 to participate in the Artificial Pancreas human clinical trials supported by the National Institutes of Health (NIH). Since we’re both sitting around and not working today, it seems like we ought to get active again and donate our parts to science.

Soon I will go to Charlottesville for my health screening and prepare for my hospital admittance. I will let you know when I go back in. I will be in the hospital for about 24 hours — two or three separate overnight visits. I am really excited about participating in Phase III of the landmark trial. We can’t get an artificial pancreas or the technology to market without some human guinea pigs. That’s me. Oink, Oink.

This blog is dedicated to the patients, doctors, nurses, researchers and big thinkers who are actively pushing research forward – in our search for solutions & cures for persons living with auto immune diseases such as type 1 diabetes and certain forms of cancer — such as liver cancer — that are tied indirectly to weakened immune systems or a virus attack. If you’re ready to learn more or join a clinical trial, check back here often for news and information. Or simply click on Clinical Trials to get started.

What is a clinical trial?

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.