DIABECELL--First Implant- Type 1

Type 1 and LADA
1

From Living Cell Technologies www.lctglobal.com:

Living Cell Technologies Limited today announced that DIABECELL® was successfully implanted yesterday in the first patient with type 1 diabetes in Auckland, New Zealand.

DIABECELL®, LCT’s encapsulated porcine cells that produce insulin, was implanted by a laparoscopic procedure into the abdomen of a 47 year old man who has had type 1 diabetes for 20 years.

This is the first of eight DIABECELL® implants to be carried out under LCT’s clinical protocol for New Zealand. The protocol was approved by the Minister of Health in June 2009 following international peer review of LCT’s DIABECELL® clinical programme.

The patient was selected based on the protocol criteria for poor control of blood glucose. Despite meticulous specialist supervision of frequent daily insulin injections, he has continuing frequent episodes of high blood glucose, high glycated hemoglobin levels (HbA1c) and unacceptable swings including low blood glucose levels (hypoglycemia).

The trial is being conducted by Dr John Baker, principal investigator and diabetes specialist based at Middlemore Hospital in Auckland. The protocol requires patients to be monitored for 8 weeks before receiving the implant. The first four patients are to receive 10,000 islet equivalents per kilogram body weight (IEQ) of encapsulated pig islets and the next four patients the higher dose of 15,000 IEQ. All recipients of DIABECELL® implants will be followed up intensively for a year and less frequently thereafter. An independent Data Safety and Monitoring Board will assess progress and provide a report six months after the first implant. Details of the trial are available at www.ClinicalTrials.gov.

Dr Paul Tan, Chief Executive Officer LCT said, “The trial in New Zealand has attracted wide global attention with more than 200 reports in the international media. With positive results from our trial in Russia to date, LCT believes it may be able to deliver even better results for people with diabetes as this trial will be using higher doses.”

DIABECELL® is designed to normalize blood glucose levels in type 1 diabetes sufferers.
DIABECELL® comprises encapsulated porcine insulin-producing cells which can be administered without the need to use immunosuppressive drugs.

Type 1 diabetes occurs when the body’s own immune system destroys the insulin-producing cells of the pancreas (called beta cells). Five to 10 percent of the more than 200 million diabetics worldwide have insulin dependent type 1 diabetes. Type 1 diabetes is associated with kidney failure, blindness, nerve damage, life-threatening cardiovascular disease and limb amputations. Current treatment options include multiple daily injections of insulin.

For further information: www.lctglobal.com

2

I am so hopeful! I have to believe this will be the answer to our wishes. Thanks, Gerri.

3

Thanks Gerri…wow…gives us something to hope for, it sounds so promising.

4

Great news! Though I do not consider this a cure, per se, as it does nothing to address the autoimmune component of Type 1. And I believe the patients may need repeat implants after a few years. If this therapy is successful and routinely available, and insurance will pay for the costs of the islet transplants (this is going to be expensive) life is going to be so much easier for Type 1s. So, Godspeed… Praying hard for this study to be successful.

5

Thanks for the update
This is great, I have been following this study for a while. I was accepted into an Islet cell transplant program about 2 years age at city of Hope which uses the immunosuppressive drugs. Well the side effects of the drugs out weighed the benefit for me so i withdrew. This is the way to go for an effective treatment (not yet cure).

6

I wouldn’t take immunosuppresants either. Way too risky.

While all these promising clinical trials are underway, I hope smart insulin becomes available as we wait.

7

Yes, wish Smart Insulin would hurry up! :wink: Dreaming of it and hoping and hoping!

8

Life is already easier for a diabetic than years ago…
improvements come faster and faster…
So yes, this gives us hope.
But playing with cells needs to be done with great care, as we don’t know the drawbacks yet (increased risk for cancer ?)…
Some follow up has to be done, and I don’t expect this to be available for the great public in the few coming years… but it will come, that I’m sure… patient my friends…
Thanks Gerri…

9

My husband had a kidney transplant four years ago (not diabetic) He was on dialysis for four years prior to that. He takes the anti-rejection drugs, various types (Myfortic, Prograf) and Prednisone and so far has had no side effects. The risk of complications from the drug far outweigh the risk of eventual death due to kidney failure. Dialysis can only support you for a while. That is why they call it End Stage Kidney Disease. Personally, I would far rather take the drugs. Just an opinion.
Sheila

10

If I needed an organ transplant to survive, I’d take immunosuppresant drugs.

Taking these drugs for a clinical trial (not a proven treatment) when it’s not a life or death choice is a different situation.

Glad your husband was able to get a kidney & is doing well!

11

If successful, I am just hazarding a wild guess… five to seven years? But I have read this would be expensive and insurance may not pay immediately if they consider the treatment experimental. In time, insurance probably would cover it though. I fully expect this to work, whether the patient is able to go off insulin or not. I would expect this to greatly improve blood sugars and make D easier to manage. It has already been done.

12

Absolutely! Your husband chose the right treatment and I am glad to hear he is doing so well with the transplant. The immunosuppressants needed for most islet transplants currently being done would be given to otherwise healthy individuals. Insulin may be safer than taking those drugs the rest of your life. The encapsulated islets do not require immunosuppressant drugs so hoping it does become available and that insurance will pay for it. I believe they have already demonstrated that it works. Just a matter of time, and money, before this becomes available.