Tag Archive for 'FDA'

California Stem-cell Institute Makes First Development Grants

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Five years after the passage of Proposition 71, the California Institute of Regenerative Medicine is awarding grants for stem-cell research targeted at clinical applications. In what both the San Diego Union-Tribune and Knight Science Journalism Tracker are calling an “irony,” ten of the 14 grants are going to researchers working with adult stem-cells.

On Thursday, October 29, the New York Times reported: “In a tacit acknowledgment that the promise of human embryonic stem cells is still far in the future, California’s stem cell research program on Wednesday awarded grants intended to develop therapies using mainly other, less controversial cells.

“The $230 million in grants awarded Wednesday to California universities and companies represent a big step toward moving stem cells from basic research toward application in treating diseases like cancer and AIDS. Grant recipients are supposed to have a therapy ready for initial human testing in four years.

“But only four of the 14 projects involve embryonic stem cells. The others will use so-called adult stem cells or conventional drugs intended to kill cancer stem cells, which are thought to give rise to tumors.

“The grants thus represent a departure from the program’s original mission. California voters approved the 10-year, $3 billion effort in 2004 largely to get around restrictions on embryonic stem cell research imposed by the administration of President George W. Bush.”

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Doctors Organization Publishes U.S.’s First Adult Stem Cell Guidelines

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In a bold move that is sure to shake the foundations of the United States FDA, a group of American doctors have published a set of strict clinical guidelines that will allow US doctors to treat patients with their own Adult Stem Cells.

Your Own Stem Cells Are Not a Drug

This move by the American Stem Cell Therapy Association comes in response to the FDA’s position that a person’s own stem cells should be classified as a drug, thus subject to the exact same set of standards that a drug like Viagra or Lipitor or Vioxx would be examined under.

However, these US doctors are correct in believing that adult stem cell therapy with the patient’s own cells is governed under the practice of medicine, not under drug production guidelines.

From the stem cell press release:

Adult stem cells can be processed with the same techniques commonly used in existing in-vitro fertilization (IVF) labs. “Like the human cells and tissue used in IVF, adult stem cells are not drugs,” stated Christopher J. Centeno, M.D., a physician who worked on the guidelines and whose medical practice includes the use of the Regenexx procedure, which uses patients own stem cells to treat orthopedic conditions.

Slowing Progress, Costing Lives- the US FDA at Work

“Making the stem cells in your own body a drug won’t make them safer, will dramatically reduce availability of treatment, and will increase bureaucratic red tape.” stated Dr. Centeno.

Dr. Centeno is absolutely right.  These are your own cells and having the FDA regulate your own body won’t be helping anybody as there is no downside to having your own stem cells implanted.

Let me repeat that- there is no downside to having your own Adult Stem Cells implanted. Either they will help you or they won’t (no effect).  This has been proven in thousands of studies.

Your own stem cells should be an extra tool your doctor should be able to use to help you.  No, adult stem cells are not a cure yet, but they do help in the majority of cases.

Again, your own stem cells should be a tool in your responsible doctor’s tool kit that may or may not be able to help, but should be made available to you as there is no downside.  What does the patient have to lose?  A man in end stage heart failure about to die- give him his own stem cells, they should help. He may not be beating Husain Bolt in a 100 meter sprint, but should improve.  A spinal cord injury victim, give him his own stem cells, they should help.  He/she may not be walking, but it could be beneficial in some ways.  A diabetic, give him his own stem cells- they should improve his insulin levels. And if your own stem cells don’t help- there is no harm done- thousands of studies have proven this.

And what if your own Adult Stem Cells work only 5% of the time for a particular lethal disease and your doctor wants to try to save your life? Hey! It will save 5% more than zero. With no downside, why not? And if the FDA has its way, that 5% will be 0. It is up to all of us to make a stand. And these clinical guidelines are the first step.

If you are a patient of any kind and reading this, I urge you to go to Safe Stem Cells Now, a patient run organization demanding the use of their own stem cells.

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US Patients Battle the FDA Over Use of Their Own Cells

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American Doctors and Patients Challenge the FDA to Save Lives Rather Than Allow Patients to Needlessly Die

A couple of weeks ago, the American Stem Cell Therapy Association (ASCTA) was formed by a group of doctors, not to debate the pros and cons of embryonic stem cell research and adult stem cell research, but to contest the FDA’s position that a person’s own Adult Stem Cells are to be classified as drugs and subject to the same regulations as Vioxx, Ritalin and thousands of other chemical deadly concoctions.

The FDA’s stance is that a person’s own stem cells must be tested as a new drug- ie. subject to 7-10 years of clinical trials and testing for each disease/condition it is used for.

As I have argued many times before, this stance is ridiculous and is costing millions of lives while sick Americans wait for the use of their own stem cells which would improve their quality of life.

Well, now a group of patients are now targeting the FDA as well.

And they have issued a press release:

A critical initiative for the ASCTA and the Safe Stem Cells NOW! movement is to bring public awareness to the FDA’s position so consumers, and those who stand to benefit from safe stem cell therapies, have the opportunity to be heard. “We get letters and calls every day from people suffering from a variety of conditions and diseases that have no known cure who are eager to access stem cell therapies.”, Hanson adds. “Many of them are forced to look outside the U.S. for treatment, which involves prohibitive travel and procedure costs.”

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Adult Stem Cells Help Minnesota Man’s Angina and Heart Disease

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Stem Cell Research Debate-Heart Disease Can Be Helped Now

While much of the United States is focused on the debate of Embryonic Stem Cell research versus Adult Stem Cell research, not much attention is given to patients benefiting from Adult Stem Cells right now. The number of patients helped by stem cell therapy for heart disease and angina in the United States is steadily increasing as more and more clinical trials are beginning.

Clinical Trials Difficult To Qualify For

David Leach of Minnesota was one of the few lucky people to actually qualify for a clinical trial. David had endured angina for the last 15 years. He tried multiple solutions including bypass surgery and taking nitro to ease the pain. However, nothing worked.

Angina and Heart Disease for 15 Years

David Leach had endured the pain of angina for 15 years because of poor blood flow feeding his heart muscle.
“It’s a lot of pressure on the chest and shortness of breath and just a sharp pain,” was how he described it.
David averaged about 2 painful episodes of angina per day as his quality of life was limited by his heart disease.

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Embryonic stem cells against paralysis; Geron hopes in Obama for public funds. Food and Drug Administration endorse it.

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A new therapy based on embryonic stem cells will give a new hope to people who did lose their ability to move in some accident. But that’s not all, because this therapy, developed by the Geron Corp., is the demonstration that in USA, since a few days from Obama‘s election, a new course in research – above all in stem cells research – has begun.

The Food and Drug Administration (FDA) frees the medics to inject spinal stem cells extracted from embryonic tissue in legs paralysed patients since a short time. The treatment in on experimental phase, but stem cells should stimulate damaged nerves to grow.
The goal is to re-activate the spinal marrow normal functions. Unfortunately it’s not so operative for patients paralysed sinc more than 1 or 2 weeks.

Geron’s whole work is funded by private; at present no public funding are planned in this field due to Bush‘s 2006 veto, despite the United States Congress gives the go-ahead.
The fact that FDA did not oppose to this, although it’s an indipendent organization, suggests that something is changing.

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Walk again after 24 years on wheel chair using Stem Cells

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From wheel chair to walk again

From wheel chair to walk again

William Orr hasn’t always been in that wheelchair, 24 years ago he survived a tragic accident while riding his bike, leaving him paralyzed from the waist down. Today, he speaks with high hopes, optimism, and an emotional strength he will one day walk again, thanks to a Bonita Springs doctor.

Bill Orr is not quite walking. But he’s getting close. And his progress may be one of the best stories of 2010 for a whole lot of reasons.

The 50-year-old Aurora man has been a quadriplegic for half his life — since a car hit him while he was riding his bike home on Route 34 in Oswego back in 1986.

In August, Orr underwent what many believe is a first of its kind stem cell procedure in Naples, Fla. — using bone marrow from his hip that doctors hope will rejuvenate the dead spine cells.

The procedure is showing “amazing” promises (…)

The enthusiasm is bigger than Bill Orr, however. Grekos believes stem cell therapy has the potential to revolutionize medicine, but it’s not going to happen through the FDA or pharmaceutical companies. “It’s going to take a grass-roots movement,” he said (…)

Whatch video…

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