Tag Archive for 'US Food and Drug Administration'

Research on Stem Cell Treatments Abroad

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If you have done any research on stem cell treatments abroad, you will undoubtedly read negative articles like this one on CNN from the mainstream media saying these companies are promising cures and are preying on the desperate, that these companies are selling “snake oil”   Nothing could be further from the truth.

The stem cell companies and stem cell doctors that are part of the Repair Stem Cell Institute offer patients a good chance at an improvement in the patient’s quality of life- they don’t offer nor promise cures.  Patients going to these stem cell therapy treatment centers abroad know this.

Unfortunately, the United States and their FDA don’t give these patients any other options.  Are they able to use their own stem cells to help their multiple sclerosis or heart disease-  Stem Cells that have been proven safe in thousands of studies? No.  What is one to do then?  These patients must go abroad for the only treatment that can help their disease or condition.

Here is a sampling of what some of these companies  affiliated with the Repair Stem Cell Institute tell their patients:

From Stem Cells China:

It’s not a cure. It’s about quality of life. Every day I see inquiries begin like this: “Can stem cells cure…?” Everyone should know the answer to that one right away. No. No known therapy utilizing stem cells can cure any medical condition. Not one.

A cure would rewrite the broken code of your genome. A cure would rewind the debilitating progression of a neuro-degenerative disease to the moment before onset. A cure would fix all the wrongs of a baby’s challenged birth. We eagerly await the development of cures and their accessibility to patients in need.

So why are people receiving stem cell therapy today? Therapies involving adult stem cells today are providing quality of life improvements for many patients. It’s no cure. Just as painkillers are not a cure for pain. They improve our quality of life if we feel pain.

But who would deny that painkillers are still worthwhile for extreme pain? Many doctors in the West are saying that they don’t have enough proof that stem cells are improving quality of life for patients. In the meantime, patients are busy coming to China and China’s stem cell clinics are busy offering the chance for quality of life improvements where none else would exist. We encourage you to explore the therapies being offered today.

From Dr. Shimon Slavin, Israel, helping people like Louis Zylstra and Arndt Roehlig

However, we have some positive and most encouraging evidence that the cells we inject may be of benefit, especially as evidenced in some patients with multiple sclerosis as well as based on the first patient we treated with spinal injury that seemed to have somewhat improved. The good news is that there are no side effects at all so there is no risk and nothing to lose (except money…). I would like to stress that since we are in very early stages of our research, nothing can be said about the clinical efficacy of our approach.  However, on the other hand, I do understand that patients in need cannot wait for all the answers to be solved and this is why we agree to offer experimental procedures for patients that understand the experimental nature of our program and consent to try and explore new treatment options.

From Dr. Roberto Fernandez Vina– For doctors who say that current stem cell therapies are “unproven,” Dr. Fernandez Viña has the following response:

How many patients must to be treated to say this is a cure? How many patients must die waiting for the word “cure?”

A lot of diseases are not totally cured with drugs but the laboratories talk about curing (HIV, Tuberculosis and a lot of malignant deseases). They say that the drugs “cure” but in reality the drugs improve the quality of life. Stem cells “cure” in the same sense. If a person is dying of diabetes and we improve the prognosis and he no longer needs insulin injections, we increase the C peptide, decrease the HbA1c, decrease protein in the urine, decrease the risk of amputation or kidney failure, in my book that is a “cure.”

From Richard Humphries, with multiple sclerosis and a stem cell recipient from Cell Medicine in Costa Rica:

I’m case study #1 in the paper (Multiple Sclerosis Study) just released and have had two stem cell treatments in Costa Rica where they promise nothing but deliver wonderful results. Secondary Progressive Multiple Sclerosis patients can’t wait on historical data. Time is not on our side but stem cells improved my quality of life and the follow up MRI looks excellent.

From the X cell Center in Germany:

Even if not all of the interactions have been conclusively researched to date, the status of the current medical insights has indeed reached a level that allows the non- hazardous treatment with adult stem cells and puts medical professionals in a position to assume responsibility for its use.

Given the proven treatment success of regenerative medicine, the question of whether more research is needed prior to therapeutic use has already been answered.

Those who nevertheless demand stem cell therapy be postponed until we know more about it are taking away patients’ rights to make their own decisions as they search for medical solutions – for the kind of help stem cell therapy does offer.

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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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Stem Cell Therapeutics Corp. Announces the FDA Has Lifted Its Clinical Hold on the Phase IIb Stroke Trial

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Stem Cell Therapeutics Corp. is pleased to announce the U.S. Food and Drug Administration (FDA) has provided a verbal confirmation to remove its clinical hold placed on NTx®-265 on September 18, 2008. This will allow SCT to commence the recruitment of patients under an amended protocol using NTx®-265 for the Company’s Phase IIb clinical trial treating acute ischemic stroke.

Dr. Alan Moore, President and CEO, commented as follows:

“We are very pleased that our series of collaborative meetings with the FDA has resulted in this positive development. We are expecting to receive written notification from the FDA in the near future following which we will finalize the plans for our stroke trial. We will issue another press release once this has been determined.”

About REGENESIS: NTx®-265 is SCT’s lead therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin (“hCG”) and Erythropoietin (“EPO”), targeting the treatment of stroke. The twin objectives of the treatment are to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke, and importantly, to direct motor, visual, and cognitive recovery after the acute ischemic stroke. Encouraging clinical results from SCT’s BETAS Phase IIa stroke trial were presented at the International Stroke Conference in February 2009, showing clinically relevant recovery in 12 of 12 patients who received the complete treatment.

About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company  focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient’s own resident stem cells. The Company’s programs aim to repair brain and nerve function lost due to disease or injury. The Company’s extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases such as traumatic brain injury, multiple sclerosis, Huntington’s disease, Alzheimer’s disease, and ALS.

These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available.

Except for historical information, this press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting.
The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.

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

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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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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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Piloting stem cells presents a challenge for treatments

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Complications and unanticipated side-effects that have slowed the progression of stem cell studies from the lab to the clinic could soon change, researchers say.
For a decade, stem cells have tantalized scientists and patients with their promise to regenerate damaged tissues and offer treatments for incurable diseases.

No one hears, however, about the individuals who died due to complications of surgery, said Dr. Hans Keirstead, a Canadian researcher who made a paralyzed rat walk back in 2004 by injecting its spinal cord with cells derived from human embryonic stem cells.
Keirstead’s lab at the University of California-Irvine just received approval from the U.S. Food and Drug Administration to conduct the same experiment in 10 people with recent spinal cord injuries.

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