20 year-old diabetes 1 patient still improving 1 year after stem cell therapy

Progress Update August 2010

From: Sean DePaula [mailto:EDITED FOR PRIVACY]
Sent: Sunday, August 15, 2010 9:57 PM
To: Jay Lenner Xcell Center
Subject: RE: Progress Report and Patient Reference

Dear Mr. Lenner,

I wanted to contact you and let you know that my insulin needs have dropped even further in recent months. I am still off long lasting insulin, and my short lasting insulin needs have dropped dramatically. I no longer take short lasting insulin for breakfast or lunch. And for dinner, I only need between 0 and 2 units of short lasting insulin. Feel free to add this information to the website if you'd like!

Thanks,
Sean DePaula

Read Sean's Complete Story at XCell-Center.com

Cord blood may preserve insulin levels in children with type 1 diabetes

GAINESVILLE, Fla. — Umbilical cord blood may safely preserve insulin production in children newly diagnosed with type 1 diabetes, according to findings from a small national pilot study presented today (June 25) at the American Diabetes Association’s 67th Scientific Sessions in Chicago.

University of Florida researchers sought to determine whether it is feasible to use a patient’s own cord blood stem cells to neutralize the body’s autoimmune attack on the pancreas and help restore the organ’s ability to make insulin, which regulates how the body uses sugar and other nutrients for energy.

“This is the first attempt at using cord blood as a potential therapy for type 1 diabetes. We hope these cells can either lessen the immune system’s attack on the pancreas or possibly introduce stem cells that can differentiate into insulin-producing cells,” said pediatric endocrinologist Dr. Michael Haller, an assistant professor of medicine at UF’s College of Medicine.

“While this is a relatively small study we can confidently say this is safe, and we have seen metabolic and immunologic changes to suggest there may be benefit,” Haller said. “It’s not curing diabetes, but this is a first step to help us learn more and get us moving in the right direction.”

Researchers got the idea in part from a patient’s father who had read that scientists elsewhere were able to reverse diabetes in mice by taking bone marrow from one animal and infusing it into its identical sibling without using chemotherapy or radiation therapy. And in the lab, scientists have been able to coax stem cells isolated from cord blood into making insulin. The man asked UF researchers whether giving a patient his or her own cord blood could have a similarly positive effect.

“We thought this was a very reasonable question and would be a safe approach as long as we refrained from using chemotherapy, radiation therapy or manipulating the cells. Since there are a lot more people out there who are banking cord blood than there were five years ago, we felt this approach would become increasingly attractive,” Haller said.

A decade ago less than 1 percent of Americans were banking cord blood; today, that figure has grown to about
4 percent and is rising, Haller said. Cord blood is rich with cells that help regulate the immune system but until now has typically been used to restore a patient’s immune system after treatments for leukemia or lymphoma.

UF researchers identified children recently diagnosed with type 1 diabetes whose families banked their
umbilical cord blood at birth. Most were still producing a small amount of insulin. The researchers then gave seven patients ages 2 to 7 intravenous infusions of stem cells isolated from their own cord blood. (They have since treated an additional four children.) The patients were evaluated for the next two years to measure how much insulin they were making on their own and to assess blood sugar levels and the function of key immune system cells.

In the first six months, they required significantly less insulin — on average 0.45 versus 0.69 units of insulin per kilogram per day — and maintained better control of blood sugar levels than children of comparable age with type 1 diabetes who were randomly selected from the clinic population. The researchers also noted that the children who received cord blood infusions had higher levels of regulatory immune cells in their blood six months after the infusion, on average 9 percent of the total cell volume compared with 7.21 percent at the time of infusion.

“This isn’t a cure-all. We think that giving these cells is essentially providing some immunotherapy and downregulating the autoimmunity these patients have,” Haller said. “Realistically, we hope to protect what’s left of their insulin-production for an extended period of time. We think the immune regulation hypothesis is more likely than the hypothesis that stem cells are forming insulin producing cells on their own.”

The idea would be to intervene and repair any early damage during the “honeymoon period” many patients enjoy — the first several months after diagnosis during which insulin needs are minimal, he added.

“Our group’s concept is that we won’t be able to cure diabetes without a combination therapy approach,” Haller said. “It’s naïve to think that with one agent we’re going to reverse a very complicated disease like type 1 diabetes. We probably need to go at it with multiple drugs to attack the various facets of the disease. Curing type 1 diabetes may require a similar approach to treating AIDS or cancer. The care of patients with these complex diseases did not markedly improve until combination therapies were administered. I suspect it will be the same with diabetes.”

The Juvenile Diabetes Research Foundation and the National Institutes of Health funded the study, with support from UF’s Clinical Research Center. UF researchers next plan to enroll up to 23 patients who will receive cord blood infusions. They also will seek to improve on the small metabolic and immunologic advantages they’ve noted so far, possibly by testing the addition of one of the many drugs currently being used in other type 1 diabetes trials.

“We need to decide which agent will work well when combined with the cord blood,” Haller said. “Right now we are not manipulating the cells. We are simply infusing the cord blood. In addition to adding other drugs, we may need to see if we can take the key cells from cord blood and safely manipulate them to improve on our findings.”

The application of human cord blood in the treatment of type 1 diabetes is of extreme importance, said Colin P. McGuckin, a professor of regenerative medicine at Britain’s University of Newcastle upon Tyne Medical School.

“The work carried out in the University of Florida has led the field in showing that cord blood contains cells which can quieten the immune system attack on the patient’s pancreas,” McGuckin said. “We know that cord blood contains very specialized cells which are there to stop rejection of the placenta of the child to the mother during pregnancy, and these are likely to be the ones which are useful for treatment in type 1 diabetes. Together with our work, showing that beta cells producing insulin can be formed using cord blood, we are on track to help diabetes patients in the future. The first step, though, has to be quietening the immune system attack, and this is why the work in Gainesville is so important.”

Stem cells could treat diabetes

Early-stage study in mice shows potential of adult blood in yielding insulin-producing stem cells; treatment could side-step ethical debate over embryonic cells.

By Aaron Smith, CNNMoney.com staff writer

June 25 2007: 11:42 AM EDT

CHICAGO (CNNMoney.com) -- Early-stage studies in mice have shown that adult blood could be a richer source of insulin-creating stem cells than fertilized eggs, according to Dr. Yong Zhao, assistant professor at the University of Illinois.

If these test results are repeated in humans, it could possibly lead to a diabetes treatment that would avoid the controversy surrounding embryonic stem cells.

Dr. Zhao, who presented his findings at the annual conference of the American Diabetes Association, emphasized the early-stage, experimental nature of his study results, which were funded by his Chicago-based university.

Dr. Zhao said he intended to seek funding from the National Institutes of Health so he could begin human studies. But even if human studies are successful, potential treatments are years away. Dr. Zhao said it could take five years just to complete the first phase of human studies.

Merck sees long-term benefits from Januvia

In his animal studies, Dr. Zhao drew blood from diabetic mice, extracted insulin-making stem cells from the blood, condensed the stem cells into a solution and then injected that back into the mice.

As a result, the diabetic mice maintained healthy blood-sugar levels for three months without any other treatment, the scientist said.

Diabetics have difficulty producing their own insulin, which is necessary to convert blood-sugar into energy. Without insulin, diabetics often suffer dangerously low blood-sugar levels known as hypoglycemia. Diabetics control blood-sugar levels by injecting insulin, or taking various drugs like Merck's (Charts, Fortune 500) Januvia, or Byetta from Eli Lilly & Co. (Charts, Fortune 500) and Amylin Pharmaceuticals. Novo Nordisk is the world leader in insulin production.

In his human studies, Dr. Zhao intends to use adult blood and blood taken from umbilical cords. Since he does not plan to use embryonic stem cells taken from eggs fertilized in vitro, the scientist would be exempt from the current restrictions on federal funding.

President Bush vetoed a Congressional bill on June 20 that would have lifted restrictions on federal funding for embryonic stem cell research. This was Bush's second veto regarding stem cell research since he took office.

Bush opposes the use of fertilized eggs for research on pro-life grounds. But many medical experts believe that embryonic stem cell research could eventually lead to treatments for crippling traumatic injuries, like severed spines and brain damage, or debilitating diseases, like Parkinson's and Alzheimer's.

Diabetic nerve damage breakthrough seen

Biotechs involved in the fledgling industry for stem cells are engaged primarily in research, with few products on the market. Geron Corp. (Charts) and Advanced Cell Technologies focus on embryonic stem cells. Cytori Therapeutics (Charts), Aastrom Sciences (Charts), Osiris Therapeutics (Charts) and Stem Cells (Charts) Inc. derive stem cells from adult tissue.

Dr. Zhao said adult humans are a richer source of insulin-making stem cells than fertilized eggs. He found that 7 percent of human embryonic stem cells are capable of making insulin, compared to 70 percent of stem cells from adult human blood and umbilical cord blood.

"Application of these stem cells is very easy to access, culture, expand, and safe, without any ethical issues and immune [system] rejection," said Dr. Zhao, in an email to CNNMoney.com "Therefore, these stem cells possess much more advantages that application of embryonic stem cells."

As a potential treatment, the scientist said blood would be drawn from human diabetics. Then, the insulin-making stem cells would be extracted from the blood and injected back into the diabetics. The patient's own blood would be used because blood from another donor has a strong chance of being rejected.

Stephen Brozak, biotech analyst for the investment research firm WBB Securities, said the study "has the potential to advance science," but the potential was hard to gauge because the study is "early, early stage."

"It's an interesting scientific discovery," said Brozak. "That's as far as I would go with it."

Correction: An earlier version of this story incorrectly referred to hypoglycemia as high blood sugar, hypoglycemia is low blood sugar. CNNMoney regrets the error.

Drug makers take aim at diabetes
Stem cell breakthrough a bust on Wall Street

New Jersey Man's Diabetes Condition Improving after Stem Cell Therapy in Germany

Retired New Jersey firefighter is reporting decreased insulin doses and lower blood glucose levels within one month after his adult stem cell treatment for diabetes (type 2), diabetes induced erectile dysfunction and peripheral artery disease in Cologne, Germany.

Cologne, Germany (PRWEB) June 19, 2007 -- Retired Fire Captain, Calvin Miller of Union City, New Jersey is reporting decreased insulin doses and lower blood glucose levels within one month after his adult stem cell treatment for diabetes (type 2) , diabetes induced erectile dysfunction and peripheral artery disease in Cologne, Germany.

Mr. Miller was recently treated at the XCell-Center using adult stem cells derived from a small amount of his own bone marrow. The stem cells were introduced directly into his pancreas using a minimally invasive catheter procedure via the right femoral artery. To battle the common diabetes complications of peripheral artery disease and erectile dysfunction, stem cells were also introduced into his thighs and calves, and into the arteries that supply the penis, respectively.

"Before scuba diving this past Sunday morning, I injected only 32% of my normal insulin dose. During the day, I ate normally - for a diabetic - without injecting any more insulin. That evening, I measured my blood sugar and I was astounded that it was only 126. A month ago, even with my full insulin doses, I never had readings below 170," said Miller.

These are the third, fourth and fifth diseases in two years for which Mr. Miller has chosen to undergo stem cell therapy. After being treated with stem cells for coronary artery disease in January 2005, he was featured in BusinessWeek Magazine (June 2005) . In September 2005, he was treated for ischemic cardiomyopathy using minimally invasive surgery.

"Actually, what really got my attention this past weekend was that I also felt a regeneration of heart function…and that was after a 3 km swim," Miller added with a grin.

About the XCell-Center
The XCell-Center is the first privately-owned center in Europe to specialize in regenerative medicine using autologous adult stem cell therapy. Newly completed in 2006, the XCell-Center features the latest medical equipment and technology. The XCell-Center is a fully licensed clinic with German specialized physicians working in accordance with German law and European guidelines. It is located on the second floor wing of the Eduardus Hospital in Cologne, Germany.

The XCell-Center currently treats Diabetes and its complications (Erectile Dysfunction and Peripheral Artery Disease), Stroke, Spinal Cord Injuries, Ischemic Heart Disease and degenerative diseases such as Multiple Sclerosis, Parkinson's and Alzheimer's.

Before the end of this year, the XCell-Center will publish clinical data coming from their SCIDEM I and II trials. In these trials, diabetes (type I and II) patients will be treated with their own stem cells and compared with a control group receiving traditional therapy. The findings will be presented at different international scientific meetings. Later this year, another clinical trial for stroke patients will commence.

For more information on Stem Cell Therapy:
XCell-Center Website: http://www.xcell-center.com

Stem Cell Therapy for Diabetes Blog: http://www.stem-cell-diabetes.blogspot.com

XCell-Center GmbH
at the Institute for Regenerative Medicine
Custodisstrasse 3-17
Cologne, Germany 50679

E-Mail: info@xcell-center.de

Phone: 1-866-680-8202 (USA Toll-Free) or (+49) 0221-802-5095 (Germany)

Fax: 1-713-583-9322 (USA) or (+49) 0221-2921-2550 (Germany)

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Adult Stem Cells a Success in Diabetes Trial

Written By: Aricka Flowers Published In: Health Care News Publication Date: July 1, 2007 Publisher: The Heartland Institute

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Adult stem cells may hold the key to long-term remission of Type 1 diabetes, according to a study published in the April 11 issue of the Journal of the American Medical Association.

Thirteen of the 15 patients treated with adult stem cells (ASCs) in a study by a team of Brazilian researchers saw their diabetes go into remission for at least six months.

ASCs are undifferentiated cells found throughout the body, which other studies have shown can divide to replenish dying cells and regenerate damaged tissues. They are so potent they have the potential to regenerate an entire organ from just a few cells.

Because ASCs are found in all tissues--including placentas and umbilical cord blood--ASC research doesn't require the destruction of human embryos, as does the touted but so far unsuccessful embryonic stem cell (ESC) research.

Numerous Successes

Diabetes joins the growing list of diseases ASCs have been shown to treat effectively. Others include blindness and spinal cord injuries.

"I think this is another step forward in being able to use your own adult stem cells to help alleviate various disease and injuries," said Dr. David Prentice, a senior fellow at the Family Research Council, a Christian policy research group in Washington, DC. "What [researchers] basically did was take the cells, do a cleansing of the body, and then reboot it with the stem cells. This is very encouraging, since this is the first trial for the procedure and some of the people have been in remission as long as three years."

Wesley J. Smith, a senior fellow at the Discovery Institute, a free-market research group in Seattle, agreed.

"This is a demonstration, and certainly not the first, of [adult] stem cells being able to show remarkable capacity to provide therapeutic benefit in early trials," Smith said.

"Embryonic stem cells have not been proven to be better than adult stem cells," Smith continued. "In fact, they have been proven to cause tumors in animal studies. The idea that the pure potency of embryonic stem cells gives them the ability to become any tissue in the body is purely theoretical. The reality is that the issue with embryonic stem cells is an ethical debate, not a scientific one."

Insistent ESC Advocacy

Policymakers, however, are largely ignoring ASCs' proven advances in order to push for more funding for ESC research.

In April, the U.S. Senate passed on a 63-34 vote the Stem Cell Research Enhancement Act of 2007 (S. 5). Introduced by Senate Majority Leader Henry Reid (D-NV), the bill would expand the possibilities for federally funded ESC research. The only ethical stipulations in the bill are that the stem cells come from leftover embryos donated by in vitro fertilization clinics, which otherwise would have been discarded.

S. 5 passed the House of Representatives in January. President George W. Bush has promised to veto it.

The Hope Offered through Principled and Ethical Stem Cell Research Act (S. 30) was also passed in April, 70-28. The legislation offers alternatives to ESC research by opening the door to the taxpayer-funded use of stem cells from dead embryos.

The bill also would fund research on ways to harvest ESCs without harming the embryo. Bush voiced his support of S. 30; at press time, it was awaiting action by the House.

ASC Funding

The success of ASC research means it's time for the political, medical, and scientific communities to devote more attention and dollars to ASC research, Prentice said.

"At the federal level, we are sort of at a point where we just can't do too much more when it comes to embryonic stem cell research, because the president says he will veto any bill that creates more money for the old lines," Prentice explained. "Where we would like to see a push at the federal level is in the area of funding to support adult stem cell line studies."

Prentice continued, "A lot of the clinical trials and federal money in adult stem cells goes to making bone marrow transfers better. But there are a lot of clinical trials [in other nations that] resulted in patients improving immensely after adult stem cell treatments. These are patients that were treated for things like brain damage, heart disease, stroke, and liver damage.

"Heart disease is the largest killer in the United States, and there are hundreds of people walking around in the world with better hearts because of adult stem cells," Prentice noted.

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Aricka Flowers (atflowers@hotmail.com) writes from Chicago.

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For more information ...

"Autologous Nonmyeloablative Hematopoietic Stem Cell Transplantation in Newly Diagnosed Type 1 Diabetes Mellitus," by Julio C. Voltarelli et al., Journal of the American Medical Association, April 11, 2007, http://jama.ama-assn.org/cgi/content/full/297/14/1568

Why are diabetics turning to stem cell therapy?

Research is now uncovering what many diabetics have known for some time.

Diabetes Cuts 8 Years Off Life

By Steven Reinberg
HealthDay Reporter Mon Jun 11, 7:02 PM ET

MONDAY, June 11 (HealthDay News) -- A diagnosis of diabetes means losing an average of eight years from your expected life span, new research shows.

In addition, diabetics are more likely to develop heart disease sooner than non-diabetics, the study found.

"Having diabetes at age 50 years and over does not only represent a significant increase in the risk of developing cardiovascular disease and mortality but also a very important loss in life expectancy and life expectancy free from cardiovascular disease," said lead author Dr. Oscar H. Franco, of the University Medical Center Rotterdam, the Netherlands, and Unilever Corporate Research, Sharnbrook, England.

Most people with diabetes -- about 95 percent -- suffer from the obesity-linked type 2 form of the blood sugar illness. That means that "prevention of diabetes is a fundamental task facing today's society aiming to achieve populations living for longer and healthier," Franco said.

His team published its findings in the June 11 issue of the Archives of Internal Medicine.

In the study, Franco's group collected data on more than 5,200 American men and women who participated in the ongoing Framingham Heart Study. These people were followed until they developed heart disease or died. In addition, the researchers noted whether they had diabetes.

According to the study, diabetic women had more than twice the risk of developing heart disease than non-diabetic women. In addition, women with diabetes who already had heart disease were more than twice as likely to die compared with non-diabetic women.

Among men, the researchers found that those with diabetes also had twice the risk of developing heart disease and faced a 1.7 times higher risk of dying after developing heart trouble, compared with non-diabetic men.

For those 50 and older, diabetic men lived an average of 7.5 years less than men without diabetes, and diabetic women lived an average of 8.2 years less. Moreover, life expectancy without heart disease still fell by 7.8 years in men and 8.4 years in women with diabetes compared with non-diabetics, Franco's group reported.

"Taking into consideration that treatment of diabetes and its complications accounts for at least 10 percent of health-care expenditure in many countries, effectively preventing diabetes will not only represent an increase in life expectancy and the number of years lived free from cardiovascular disease but may also represent important savings for health care, at least with respect to direct medical costs," Franco said.

One expert believes the study reflects the dangers posed by diabetes and the need for more efforts to prevent and control the disease.

"It's sobering to think about the number of years of life lost," said Dr. Larry Deeb, president for medicine and science at the American Diabetes Association. "We ought to be able to reduce the cardiovascular risk because we can manage diabetes better today, but we're not."

Deeb believes the new findings highlight the tragic results of not controlling the illness. "This is a powerful argument to people who have diabetes, that you have to control the diabetes," he said.

More information

For more information on diabetes, visit the American Diabetes Association.

A diabetes patient's report on his stem cell therapy

Here is a brief summary of the results reported by an XCell-Center patient from Southern California following his adult stem cell therapy for diabetes. To read his entire story Click Here.

First stem cell treatment in 2006

In November 2006 the doctors extracted bone marrow from my hipbone. The procedure was completely painless. After that the stem cells were isolated and processed at the laboratory. Once that process had been completed the cells were re-injected by angiography. This means a small catheter was placed in the artery of my leg and was directed to the pancreatic artery and there the cells were injected. In contrast to the extraction, the re-injection process was not completely painless and it hurt just a little bit. How curious I was about the changes in prospect.

The result

I was told that I would have to wait for approximately two to six months until any effects would occur. However, I faced significant improvement only two months after the cells had been re-injected. At night my blood sugar dropped dramatically. Today I have to take 60% less of the immediate release insulin and 40% less of the slow release insulin. My blood sugar keeps dropping and I am still cutting down on insulin. I think that is just great!

For the full story - click here.