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

Posted on 4 May 2013 by Don Margolis

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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SPAIN – Embryonic stem cells. Health minister: conditions exist to perform clinical experiments

Posted on 22 April 2013 by Stem Man

: Image by dalequetepego via Flickr

In Spain the “conditions exist to perform experiments with this technique”. Health Minister Bernat Soria experienced a personal triumph with the approval of the first human testing with embryonic stem cells, even if it did occur in the US. He added that he is working on regulations “so that all of this, which is already legal, is effective in practical terms: both to provide guarantees for the researchers and volunteers and to facilitate procedures.

He also announced that his intentions have materialized in an agreement with the Governor of California, who, although a Republican, has made big investments into this field.

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Why Embryonic Stem Cells Are Obsolete

Posted on 8 April 2013 by Stem Man

: Image via Wikipedia

Scientists may be growing impatient, but President Obama has been rightly taking his time in addressing a campaign promise to lift the ban on federal funding for research using new lines of stem cells to be taken from human embryos. Even for strong backers of embryonic stem cell research, the decision is no longer as self-evident as it was, because there is markedly diminished need for expanding these cell lines for either patient therapy or basic research. In fact, during the first six weeks of Obama’s term, several events reinforced the notion that embryonic stem cells, once thought to hold the cure for Alzheimer’s, Parkinson’s, and diabetes, are obsolete. The most sobering: a report from Israel published in PLoS Medicine in late February that shows embryonic stem cells injected into patients can cause disabling if not deadly tumors.

The report describes a young boy with a fatal neuromuscular disease called ataxia telangiectasia, who was treated with embryonic stem cells. Within four years, he developed headaches and was found to have multiple tumors in his brain and spinal cord that genetically matched the female embryos used in his therapy.

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USA – Federal Financing for Stem Cell Research, Including Stem Cells

Posted on 9 February 2013 by Stem Man

: Image by Getty Images via Daylife

After Barack Obama’s victory in the U.S. presidential elections, the economic community, in the middle of a recession and the worst financial crisis in the past decades, continues to hold its breath. The Democrat’s victory induce change and potentially more difficult times for the energy, pharmaceutical, telecommunications, and defense sectors, while the biotechnology and alternative energy sectors could be strengthened by the outcome of the elections. Obama has promised to increase investments in wind and solar energy and to spend 150 billion dollars in 10 years to hasten the development of hybrid automobiles and to increase the use of alternative energy on an “industrial scale”.

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Geron explains stop on stem cell study

Posted on 31 January 2013 by Stem Man

MENLO PARK, Calif., August 18, 2009 – Geron Corporation announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.

Since filing the IND, Geron has been undertaking studies to enable dose escalation of its spinal cord injury product, and has been investigating application of the product to other neurodegenerative diseases. The company has also been performing additional product characterization and conducting further animal studies. Data from this work has been submitted to the FDA. Geron will work closely with the FDA to facilitate their review of the new data and to release the clinical hold. No patients have yet been treated in this study.

August 27, 2009 – Geron Corporation today provided additional comments on the recent clinical hold on its Spinal Cord Injury IND.

As biologic therapeutics advance in clinical trials, it is common practice to optimize product characteristics, improve manufacturing efficiency and scale, and to test the product in multiple disease models. As part of these ongoing efforts at Geron with respect to GRNOPC1, various animal studies were, and continue to be, performed to characterize the product’s effects in vivo. In previous animal studies of GRNOPC1 using materials that passed release specifications, a very low frequency of injected animals developed microscopic cysts in the regenerating injury site. These cysts were non-proliferative, confined to the injury site, and had no adverse effects on the animals. No animals developed teratomas or any other ectopic structure. Cysts of much larger size appear in the spinal cord scar tissue of up to 50% of patients with spinal cord injury.

A just completed animal study showed a higher frequency of cysts, although their characteristics were similar to the cysts seen in previous studies: non-proliferative, confined to the injury site, smaller than the injury cavity and not associated with adverse clinical outcomes.

As part of our ongoing product improvement efforts, new candidate markers and assays for product release have been identified that are linked with cyst formation across all animal studies in which cysts were found. Importantly, a manufactured lot of GRNOPC1 that was assessed using these markers and assays showed no cysts in another recently concluded animal study in spinal cord injured rats.

We have submitted these data to the FDA and are in discussions with the agency to answer its questions and proceed with the clinical trial. We are committed to the optimization of all our hESC-based products as we improve the manufacturing process and identify improved product release criteria.

from Geron

http://www.geron.com/media/pressview.aspx?id=1187

http://www.geron.com/media/pressview.aspx?id=1188

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