Newswise Researchers at the University of California, San Diego School of Medicine, in partnership with ViaCyte, Inc., a San Diego-based biotechnology firm specializing in regenerative medicine, have launched the first-ever human Phase I/II clinical trial of a stem cell-derived therapy for patients with Type 1 diabetes.

 

The trial will assess the safety and efficacy of a new investigational drug called VC-01, which was recently approved for testing by the U.S. Food and Drug Administration. The 2-year trial will involve four to six testing sites, the first being at UC San Diego, and will recruit approximately 40 study participants.

 

The goal, first and foremost, of this unprecedented human trial is to evaluate the safety, tolerability and efficacy of various doses of VC-01 among patients with type 1 diabetes mellitus, said principal investigator Robert R. Henry, MD, professor of medicine in the Division of Endocrinology and Metabolism at UC San Diego and chief of the Section of Endocrinology, Metabolism & Diabetes at the Veterans Affairs San Diego Healthcare System. We will be implanting specially encapsulated stem cell-derived cells under the skin of patients where its believed they will mature into pancreatic beta cells able to produce a continuous supply of needed insulin. Previous tests in animals showed promising results. We now need to determine that this approach is safe in people.

 

Development and testing of VC-01 is funded, in part, by the California Institute for Regenerative Medicine, the states stem cell agency, the UC San Diego Sanford Stem Cell Clinical Center and JDRF, the leading research and advocacy organization funding type 1 diabetes research.

 

Type 1 diabetes mellitus is a life-threatening chronic condition in which the pancreas produces little or no insulin, a hormone needed to allow glucose to enter cells to produce energy. It is typically diagnosed during childhood or adolescence, though it can also begin in adults. Though far less common than Type 2 diabetes, which occurs when the body becomes resistant to insulin, Type 1 may affect up to 3 million Americans, according to the JDRF. Among Americans age 20 and younger, prevalence rose 23 percent between 2000 and 2009 and continues to rise. Currently, there is no cure. Standard treatment involves daily injections of insulin and rigorous management of diet and lifestyle.

Hong Kong LEmed, the specialist stem cell and laser therapy research and distribution group, announced today that it is supporting ALS research which uses Adult Stem Cells, the only stems cells to successfully complete clinical trials for incurable diseases.

 

Wan Chai, Hong Kong, September 15, 2014 -- Hong Kong LEmed (Leading Edge Medical Ltd.), the specialist stem cell and laser therapy research and distribution group, announced today that it is supporting ALS research which uses Adult Stem Cells, the only stems cells to successfully complete clinical trials for incurable diseases.

 

In view of the enormous amount of attention the ice bucket challenge has brought to ALS (Amyotrophic Lateral Sclerosis) often referred to as Lou Gehrig's Disease, LEmed is excited to be at the forefront of the revolutionary stem cell treatment technology used to fight this horrific disease.

Millions of Americans took the challenge. They doused themselves with ice water and sent a check to the ALS Association to help fund the fight against the almost always deadly disease. Now, there is hope for a treatment, coming out of Isreal.
 

The treatment is called NurOwn, and it was developed by the Isreali biotechnology company BrainStorm Cell Therapeutics. The treatment harvests a patient’s stem cells from their bone marrow, treats the cells with chemicals until they grow new neurons, then injects them into that patient’s spinal fluid. Researchers hoped NurOwn would slow the progression of ALS, and it appears to have done that in several Isreali patients.
 

That success in Isreal has led to Phase II clinical trials at three locations in the United States. Those in the American ALS community — like Tanner Hockensmith, with the Texas Chapter of the ALS Association — are watching these trials closely.

“It’s an exciting, new, scientific breakthrough that we haven’t really seen, and there have been a lot of advances about how to come up with stem cells, looking past embryonic stem cells, going to adult stem cells and regrowing them for trials and treatments, so there are still a lot of exciting things happening.”

So does that mean for adults there is no hope for stem cell retrieval from their adult teeth and little chance of success if they are needed in stem cell therapy?

 

'Not necessarily', says Mike Byrom, Chief Scientific Officer at specialist tooth stem cell bank, BioEden.

'Stem cell therapy is not a black and white type of event. There are varying degrees of success based on many factors of which the capacity of the cells is one. The functional capacity of a 44 year old cell is not as good as that of a 6 year old but that does not mean that they have no value. Our requirements for storing material mean that the cells demonstrate acceptable growth rates, expected cellular morphology and growth characteristics which indicate their ability to differentiate into tissue specific lineage cell types. If the cells do not meet our minimum criteria for usefulness we will not store them.

Aside from these tests we cannot make any specific guarantees about the cells usefulness. Adults should not be put off attempting to store their stem cells and can have faith that if we successfully complete the process of stem cell extraction then the cells are of high enough quality to be useful should they be required.

BioEden do not make any charge for the process of harvesting stem cells where no viable stem cells can be found.

Read the full story at http://www.prweb.com/releases/2014/09/prweb12158856.htm

From Great Britain in 2014 comes proof #4: 

Cochrane Library, certainly the world’s #1 analyst of collected medical data, says it as clearly as we do…and they have 23 sources, not 3 as we showed you above, creating a huge combined study of 1255 patients. Their results:

“only about 3 per cent of people treated with their own stem cells had died compared to 15 per cent in the (standard cardiology) control group”….which is exactly what we have been saying since 2008, when Dr. Vina confirmed our 2007 work.

• ASC have improved the lives of hundreds of no-hope heart patients each year starting 2005.

• The success rate for heart patients is 2/3 which mean two out of three stem cell patients get better and one does not (but suffers no medical loss).

• We have dozens of patients so treated from 2005 through this summer, all of which would love to talk to new patients and tell them about their experience.