read, write, act snd think
hodpitsls tun by lawyers are merchants of death
death is a contact sport choose wisely
see uspto.gov inventor search faustman
LI doctor leads study of Type 1 diabetes’ effects on the brain
Dr. Alan M. Jacobson of NYU Winthrop, with $4.2M grant, is coordinating a research team to look for key predictors of cognitive impairments.
Pharma & Healthcare 26,960
Dr. Denise Faustman
Follow us
Dr. Faustman's type 1 diabetes research has earned her notable awards such as the Oprah Achievement Award for “Top Health Breakthrough by a Female Scientist” (2005), the "Women in Science Award" from the American Medical Women’s Association and Wyeth Pharmaceutical Company for her contributions to autoimmune disease research (2006), and the Goldman Philanthropic Partnerships/Partnership for Cures “George and Judith Goldman Angel Award” for research to find an effective treatment for type 1 diabetes (2011). Her previous research accomplishments include the first scientific description of modifying donor tissue antigens to change their foreignness. This achievement earned her the prestigious National Institutes of Health and National Library of Medicine “Changing the Face of Medicine” Award (2003) as one of 300 American physicians (one of 35 in research) honored for seminal scientific achievements in the United States.
Dr. Faustman earned her MD and PhD from Washington University School of Medicine in St. Louis, Missouri, and completed her internship, residency, and fellowships in Internal Medicine and Endocrinology at the Massachusetts General Hospital in Boston, Massachusetts.
by G Ristori · 1999 · Cited by 89 · Related articles
Neurology. 1999 Oct 22;53(7):1588-9. Use of Bacille Calmette-Guèrin (BCG) in multiple sclerosis. Ristori G(1 ), Buzzi MG, Sabatini U, Giugni E, Bastianello S, Viselli F, Buttinelli C, Ruggieri S, Colonnese ...
Official Title: Phase 2-3 Use of Bacille Calmette-Guèrin (BCG) Vaccine in Patients With a First Clinical Demyelinating Episode: a Multicenter, .... Buttinelli C, Salvetti M, Ristori G. Vaccinations and multiple ...
Coverage of Dr. Ristori and colleagues' trial using the BCG vaccine in multiple sclerosis: http://www.bbc.co. uk/news/health-25207033.
Dec 5, 2013 · Dr. Ristori added that there has been some experience with type 1 diabetes in which the BCG vaccine has been associated with an improvement in the course of the disease over long-term follow- up.
Dec 6, 2013 · Giovanni Ristori, M.D., Ph.D., at Sapienza University, Rome, and his team administered the TB vaccine .... It could take years for BCG vaccine to become a standard treatment against MS ...
by G Ristori · 1999 · Cited by 89 · Related articles
Use of Bacille Calmette–Guèrin (BCG) in multiple sclerosis. G. Ristori, PhD,; M.G Buzzi, MD,; U. Sabatini, PhD,; E. Giugni, MD,; S. Bastianello, MD,; F. Viselli, MD,; C. Buttinelli, MD,; S. Ruggieri, MD ...
by NK Sethi · 2014 · Cited by 1 · Related articles
Jul 15, 2014 · Ristori et al. reported the benefits of Bacille Calmette-Guérin (BCG) vaccination after clinically isolated syndrome (CIS). BCG vaccination may prevent progression to clinically definite multiple ...
by M Kowalewicz-Kulbat · 2017 · Related articles
May 30, 2017 · Introduction: Bacillus Calmette-Guérin (BCG) is the only available vaccine against tuberculosis. Although its protective efficacy against pulmonary tuberculosis is still under debate, it provides ...
Denise Faustman · 2014 · Medical
Dr. Karaci's data shows that multiple doses of BCG, with the first dose in the neonatal period, are most ... Ristori, an expert on multiple sclerosis (MS), opened his talk with the historical point that the use of BCG or ...
Here's How Lee Iacocca Wants To Cure Diabetes
In the late 1990s, former Chrysler CEO Lee Iacocca handed more than $10 million to Massachusetts General Hospital (MGH) scientist Denise Faustman and instructed her to transform an ancient tuberculosis vaccine into a cure for type 1 diabetes. Today Faustman announced the latest milestone in that project—FDA clearance to launch a large trial in people based on what her lab learned from that early research. And the 90-year-old auto magnate continues to fund her studies through the Iacocca Family Foundation, which he founded in 1984 in memory of his late wife, Mary, who died of complications from diabetes.
The trial, announced at the American Diabetes Association conference in Boston, will investigate whether treating patients with the vaccine, bacillus Calmette-Guérin (BCG), will improve natural insulin production in adult patients whose pancreases still produce small but detectable levels of the hormone. If it works, BCG might one day be used to essentially reverse the disease in some patients—even adults who have suffered from diabetes from childhood—says Faustman, director of MGH’s immunobiology laboratory and the study’s principal investigator. And it wouldn’t cost much, either, since BCG has been around for nearly a century and is available in generic form.
“We’re not only going for something cheap and safe, but also trying to figure out a good treatment that might reverse the most severe form of the disease in people who are 15 or 20 years out,” Faustman says.
Here’s how BCG works: The vaccine prompts the immune system to make tumor necrosis factor (TNF), a protein that destroys the abnormal T-cells that interfere with the pancreas’s ability to make insulin. That elevation of TNF has already been well-proven to be quite therapeutic in some settings—BCG, in fact, is approved by the FDA not only to prevent tuberculosis but also to treat bladder cancer.
Faustman’s lab spent years doing basic science experiments to show TNF can temporarily eliminate the abnormal T-cells that cause type 1 diabetes. Iacocca’s foundation, which had been supporting some of that work since coming across the lab’s earliest studies, invited Faustman to present the results of her research at a board meeting in 1999, she recalls.
Iacocca asked Faustman why she wasn’t using BCG to cure diabetes in mouse models of the disease. “I said, 'It’s too early. We need to do more basic science,'” Faustman recalls. “He looked at me and said, 'You know, it’s my money.' We made a deal that if I would aggressively go forward in the mouse he would support me. He gets the credit for supporting the basic science that led to the discovery that TNF is needed in type 1 diabetes.”
Recommended by Forbes
With continued funding from the foundation and other supporters, Faustman launched a small phase 1 clinical trial in people designed to prove that BCG would kill the bad T-cells and stimulate good T-cells in a way that would restore insulin secretion. It
worked, though the positive effects were transient. So Faustman started planning a larger phase 2 study to prove that regular injections of BCG, followed by periodic booster shots, would produce a sustained response, and to determine whether that response might improve over time as the pancreas regenerates.
worked, though the positive effects were transient. So Faustman started planning a larger phase 2 study to prove that regular injections of BCG, followed by periodic booster shots, would produce a sustained response, and to determine whether that response might improve over time as the pancreas regenerates.
Still, Faustman’s team had to overcome one big hurdle before the FDA would approve the phase 2 trial: a massive shortage of BCG. Two of the biggest producers of the vaccine, Merck and Sanofi , have suffered production problems, leading to huge manufacturing delays. The issue has left some bladder cancer patients in the lurch, as reportedrecently in the Wall Street Journal. Faustman and her colleagues, who had been using Sanofi’s vaccine, had to go looking for an alternate supplier.
So MGH collaborated with a division of the Bill & Melinda Gates Foundation and the World Health Organization to secure the vaccine for the trial from a drug manufacturer that’s run by the Japanese government, Faustman says. “We had to get the FDA to certify that [the manufacturer's] processes are up to U.S. standards so the BCG can be used for trials,” she says. “This is not something that academics normally do, but we were determined.”
Faustman’s team has raised $19 million of the $25 million needed to complete the phase 2 study, thanks largely to the Iococca Family Foundation, which continues to be the project’s biggest source of support. “I made a promise to my late wife to find a cure for type 1 diabetes,” Iococca said in a statement. “Now my family and I look forward to the continued progress and are proud to support this effort to get closer to that goal.”
Faustman’s plan is to enroll 150 adults with diabetes, some of whom will receive BCG, with the others getting a placebo. The patients will have two injections four weeks apart and then annual injections over four years. They will continue to take insulin, though the research team will be watching closely to see if the BCG reduces the amount of insulin needed to maintain blood-sugar control, Faustman says. “We expect the metabolic effect to occur gradually over five years,” she says.
However it turns out, Faustman says, she will always be grateful to Iacocca for having the patience to continue funding the BCG research. “Many other people support us now, but the Iacocca Foundation makes a huge contribution to these trials,” she says. “He sees the big picture and is willing to look for ways to change the paradigm.”
Also on Forbes:
Quick Links
> Clinical Trials Info
>Sign up for e-mail updates
>Support the Faustman Lab
>Host an event or fundraiser
>Patient information forms
> Clinical Trials Info
>Sign up for e-mail updates
>Support the Faustman Lab
>Host an event or fundraiser
>Patient information forms
Dr. Denise Faustman
Get updates on our research
Keep in touch with the Faustman Lab. Sign up for e-mail updates on the clinical trials and more.
>Sign up
Keep in touch with the Faustman Lab. Sign up for e-mail updates on the clinical trials and more.
>Sign up
>Get information on our clinical trials
For questions about the clinical trial, please e-mail us directly.
>E-mail us
For questions about the clinical trial, please e-mail us directly.
>E-mail us
Follow us
Our Phase II Trial Has Launched Read the press release
Interested in the Phase II Trial?
Please email us directly.
------------
Your donation will directly support our Phase II research.
Raised to date: $20 million
Our total need: $25.2 million.
Raised to date: $20 million
Our total need: $25.2 million.
The Faustman Lab at Massachusetts General Hospital
Denise Faustman, MD, PhD, is Director of the Immunobiology Laboratory at the Massachusetts General Hospital (MGH) and an Associate Professor of Medicine at Harvard Medical School. Her current research focuses on discovering and developing new treatments for type 1 diabetes and other autoimmune diseases, including Crohn's disease, lupus, scleroderma, rheumatoid arthritis, Sjögren's syndrome, and multiple sclerosis. She is currently leading a human clinical trial program testing the efficacy of the BCG vaccine for reversal of long-term type 1 diabetes. Positive results from the Phase I study were reported in 2012.Dr. Faustman's type 1 diabetes research has earned her notable awards such as the Oprah Achievement Award for “Top Health Breakthrough by a Female Scientist” (2005), the "Women in Science Award" from the American Medical Women’s Association and Wyeth Pharmaceutical Company for her contributions to autoimmune disease research (2006), and the Goldman Philanthropic Partnerships/Partnership for Cures “George and Judith Goldman Angel Award” for research to find an effective treatment for type 1 diabetes (2011). Her previous research accomplishments include the first scientific description of modifying donor tissue antigens to change their foreignness. This achievement earned her the prestigious National Institutes of Health and National Library of Medicine “Changing the Face of Medicine” Award (2003) as one of 300 American physicians (one of 35 in research) honored for seminal scientific achievements in the United States.
Dr. Faustman earned her MD and PhD from Washington University School of Medicine in St. Louis, Missouri, and completed her internship, residency, and fellowships in Internal Medicine and Endocrinology at the Massachusetts General Hospital in Boston, Massachusetts.
© 2014 Massachusetts General Hospital
Dr. Alan M. Jacobson, chief research officer at NYU Winthrop Hospital in Mineola, on Wednesday, Nov. 8, 2017. Photo Credit: Barry Sloan
For nearly a century, scientists have asked how diabetes affects the aging brain. Now a Long Island medical investigator — with the help of a $4.2 million grant — is beginning the hunt for answers.
Dr. Alan M. Jacobson, chief research officer at NYU Winthrop Hospital in Mineola, has been awarded the money by the National Institutes of Health. He is to lead a consortium of medical centers throughout the United States and Canada with the aim of understanding how Type 1 diabetes affects the most complex organ in the known universe — the human brain.
Participants will be 60 and older, ages when the risk rises for cognitive impairments, with or without diabetes.
Earlier medical investigations have shown that diabetes adversely influences the brain through a telltale triad — uncontrolled blood sugar, high blood pressure and high cholesterol. All three are part of the condition.
The team will be on the lookout for key predictors of cognitive impairments as they collect information on hundreds of people over the next five years. The research is just getting organized, Jacobson said.
His game plan is to delve into every possible nuance about cognitive function under the impact of a lifelong and powerful disease, and employ imaging technology to eavesdrop on each participant’s brain.
“We will be using MRI and a variety of different techniques to study brain structure, brain physiology and changes in vascular blood flow,” Jacobson said. The research will attempt to answer unresolved questions about brain shrinkage, memory loss and cognitive declines in thinking and problem-solving that can occur in some diabetics.
For people with any hints of problems, Jacobson said there is a key strategy to protect the brain: controlling blood sugar — the same strategy that protects the heart, eyes and kidneys, all of which are vulnerable to assault.
Type 1 diabetes is the form of the disease that usually begins in childhood, although not exclusively so, and is marked by a lifelong dependence on insulin to control glucose, or blood sugar.
Type 1 differs from Type 2 diabetes, which is characterized by what doctors call insulin resistance. Those patients generally make some insulin, but their bodies do not utilize the hormone efficiently.
Other scientists have documented memory and cognitive problems in people with Type 2. Jacobson’s research will involve people with Type 1 who have been participating in a large, ongoing research project for more than 30 years. Many of these patients want to know if memory problems will be part of their future.
Questions about diabetes and the brain first emerged nearly 100 years ago, shortly after the discovery of insulin in 1921.
The hormone’s emergence as a medication transformed Type 1 from a death sentence into a manageable chronic disease. Patients were further aided when scientists in the late 1970s produced human insulin through genetic engineering, eliminating the therapeutic use of pig insulin in humans.
As early as the 1980s, research revealed that patients who maintained impeccable glucose control had fewer cognitive problems, said Dr. Gerald Bernstein, an endocrinologist who is not involved in Jacobson’s research.
Bernstein, coordinator of the Friedman Diabetes Program at Lenox Hill Hospital in Manhattan, said “tight control” of glucose aids brain health.
“Glucose is the main fuel for the brain,” Bernstein said. “The brain really doesn’t function without it. But when glucose is elevated, it has an adverse impact on all cells in the body, including the brain.”
Jacobson is well aware of diabetes’ signature on the human brain, which he expects to see in some patients.
“The changes that we are anticipating are decreases in brain volume and alterations in small vessels that manifest as very small bleeds or infarctions — damage to the brain tissue,” he said.
But he also expects that any observations of early adverse signs can pave the way to mitigating the problems.
“We might be able to provide patients with a better sense of what they can do over their lives with Type 1 diabetes to prevent problems in later years [and] avoid cognitive dysfunction,” he said.
No comments:
Post a Comment