Are you or a loved one interested in receiving stem cell treatment? For free treatment information, please fill out our treatment form or email me don@repairstemcells.org and just put TREATMENT in the subject box.

Drug Companies and FDA Trying to Slow Adult Stem Cell Progress

In a startling new interview on stem cell research and adult stem cells in the near future, Dr. Christopher Centeno warns that Big Pharma and the FDA are teaming to control the use of a person's own stem cells thus slowing innovation and the use of Adult Stem Cells to help patients now.

American Stem Cell Therapy Association

Dr. Centeno has formed the American Stem Cell Therapy Association to challenge the FDA's assertion that a person's own stem cells are a drug and thus should be regulated as such ie. subject to 7-10 years of clinical trials for each particular disease and condition.  That is 10 years for heart patients, 10 years of trials for stroke patients etc.

The FDA is Killing People By Slowing Down Use of a Person's Own Stem Cells

The article/interview in H+ magazine states:

If we're not careful, these therapies could become the exclusive domain of the pharmaceutical industry, as regulated by the Federal Food and Drug Administration (FDA). This could push the availability of this tool kit 15 to 20 years into the future. The opportunity-cost in terms of morbidity and mortality could be catastrophic.

"The Opportunity-cost in terms of morbidity and mortality could be catastrophic? This is just the author's nice PC way of saying that the FDA is killing people by trying to regulate the use of our own cells.  If the FDA slows down the use of Adult Stem Cells- each year millions will suffer and die needlessly.


More from the article:

To Dr. Centeno (a pioneer in Adult stem cell therapy), it is inconceivable that a person’s own cells could be classified as a drug —  but that's exactly what the FDA wants to do. “The FDA is working to protect the interests of Big Pharma,” he says. “If we wanted to insert some kind of new genes into these cells, we might all agree that could be a drug  — a new entity. But what we're doing is simply culturing a person’s own cells. Most of the cells are bone-marrow derived; you can get them from synovial fluid in the knee or from other locations.”

I recommend you read the whole article carefully and see how the FDA is not helping and protecting and serving us-  but in reality, is hurting us.

Here is the link to the Adult Stem Cell article

If you are a doctor and interested in joining forces with Dr. Centeno in taking on the FDA- go to the http://www.stemcelldocs.org

If you are a patient or just interested in fighting the FDA for the use of our own stem cells- go to http://www.safestemcells.org

Are you or a loved one interested in receiving stem cell treatment? For free treatment information, please fill out our treatment form or email me don@repairstemcells.org and just put TREATMENT in the subject box.

Stem Cell Research Study Reveals Stroke Patients Helped by Own Stem Cells

A new stem cell research study/trial recently completed shows that implanting a person's own Adult Stem Cells helps stroke patients overcome partial paralysis. Dr. Kameshwar Prasad of the All India Institute of Medical Sciences (AIIMS) will present his stem cell study at the European Stroke Research Conference in May, 2009.

Stroke Victims Own Adult Stem Cells Used

In the stem cell study that took place in New Delhi, India, 12 stroke victims had their own stem cells implanted within 1 month after a stroke. Also, 3 stroke patients were used as a control group and were not given any stem cells.

Process of Stem Cells for Stroke

1. Adult Stem Cells extracted from patient's bone marrow


2. Stem Cells are then purified


3. Patient's own stem cells are then reintroduced intravenously into the antecubital vein (in the forearms, near the elbow)


4. Stem Cells migrate to area of injury (in this case- the brain)


5. Adult Stem Cells enhance repair process and reduce brain damage

The Stem Cell Treatment Results

At the beginning of the stem cell study, none of the 12 stroke patients were able to carry out daily activities, use the toilet, take a bath, dress and eat independently.

However, within 1 year, 70% (I assume 7 or 8 of the patients) were able to overcome their handicaps and successfully return to previous activities like playing golf, working in the office and cooking.

Only 1 out of the 3 stroke patients in the control group were able to go back to their normal routine.

No Side Effects From Your Own Stem Cells

From the stem cell article:
"The stem cells had excellent safety profile. After carrying out Pet scans and MRIs thrice in a year on patients who received stem cells, we found no side-effects. This study shows that stem cells are a safe and feasible therapy in acute stroke. This holds promise and needs to be confirmed in a bigger study,'' Dr Prasad said.

Of course there were no side effects, the trial used the patient's own cells. Rejection isn't an issue.  As I say time and time again, the patient has everything to gain and nothing to lose.  There is no downside to this treatment.  It is a shame this isn't being put to use in the United States and made available to everyone who may need it.

These same doctors will follow up this stem cell clinical trial for stroke with a 120 patient trial in the next 3 years.  Hopefully, this will speed things up for Adult Stem Cells to be accepted sooner rather than later.

Related Stem Cells for Stroke Success Stories

The results of this study comes just after I covered this stem cell trial for stroke in Texas.  Also, earlier this year, I covered the stem cell tea bag which helped a German stroke victim as well.

Are you or a loved one interested in receiving stem cell treatment? For free treatment information, please fill out our treatment form or email me don@repairstemcells.org and just put TREATMENT in the subject box.

Why all the emphasis on Embryonic Stem Cell research and so little written about Adult Stem Cell Research?

Researchers have known about adult stem cells (ASC) for 40 years, embryonics (ESC) for almost as long. For most of that time, bone marrow and ASC have been successfully used to help certain forms of cancer, leukemia and a couple of uncommon diseases. Then, in 1998, two events in the USA shook the ground of the medical world forever, though it wasn’t immediately clear how it would play out.

At the University of Wisconsin, Madison, Dr. Jamie Thomson isolated, for the first time, a line of embryonic stem cells. Meanwhile, at Duke University, Prof. Doris Taylor wrote the seminal paper which let the world know that ASC had helped cure heart disease in rodents. Both doctors thought human benefits would be a very long time away.

Thomson was correct, saying it would take “decades.” Taylor was, in her own words, “a little naïve” for not realizing that the medical community would take off and use her concept virtually immediately! First came a year or two of animal tests, then, in Paris, 2000, doctors gave a dying 70-year-old heart patient bone marrow cells and he lived four years, at which time the doctors ‘fessed up and released his name. In 2001, USA pioneer Warren Sherman, MD (Columbia U, Mt. Sinai NY Hosp) went to Rotterdam and became the first American to implant ASC into a human heart. However, if you can believe it, the same Sherman, calls those that have taken forward what he did eight years ago, “snake oil salesmen.”

In 2002, a very daring clinical trial led by Dr. Hans Dohmann plus six colleagues in Brazil took 21 transplant candidates and gave 14 of them bone marrow cells. The results were so spectacular that the AHA accepted the paper and it was presented in 2003. Five of the seven in the control group opted in to make a total of 19 stem cell transplants. The mortality rate for transplant candidates is about 35% per year. At that rate there would be, of those 19, only 2.2 patients still alive after five years. There were, in fact, 12 alive as of Dec. 31, 2007; more than five years down the road.

In 2003, Dr. Andreas Zeiher of the Goethe Institute in Frankfurt began much larger trials. As of 2007, he has overseen more ASC implants into hearts than anyone, both in and out of clinical trials.

In 2004, Dr. Amit Patel of Pittsburgh completed two of the most successful trials ever, especially when, in Uruguay, he proved, on a group of ischemic heart failure patients, that a bypass plus cells was infinitely better than a bypass only. That same year, TheraVitae, in Israel, developed a new, powerful blood-derived stem cell and dared to treat the sickest patients no clinical trial would consider. Also in 2004, one of the Brazilians, Dr. Perin, came to Texas and used the Brazil results to get the first ASC heart clinical trial approved by the FDA. Over a dozen such approvals were granted in the next 12-18 months.

Meanwhile, around the world, while USA stem cell research remains mired in politics instead of science, ASC advances in virtually every sector of medicine are rocketing forward without any sign of letting up. In 2005, Drs. Vina & Saslavsky in Argentina completed the very first successful diabetes2 stem cell clinical trial in the world: 13 out of 16 successfully cured. Spinal problems and emphysema and renal failure and cirrhosis of the liver treatments will be moving to the forefront in 2008-9. (Yes, but mostly in China and elsewhere, while Americans die with those diseases without a chance of help from their “doctors.”

TheraVitae has published two papers showing that ASC could easily produce the neurons that embryonic fanatics still lie about and claim cannot happen. That opened the way to research brain and nerve and immune system disorders, but America isn’t even trying. China is showing the way for neurological disorders such as Parkinson’s, Spinal Cord Injury, Stroke, Multiple Sclerosis and others, including what is secretly America’s fastest growing disease, Autism . By 2015 we’ll see some trials, and, knowing ASC, they will be successful, but will NOT lead to treatments. Proof? Those above-mentioned USA heart clinical trials are now five years down the road from Dr. Perin’s approval. Not a prayer of helping anyone in the next five years, because the American Medical System will not allow its profits to be disturbed.

Oh, and embryonics---nothing to report. Not one person helped. Not one trial approved (or even applied for). ** But lots of press releases bragging about “discoveries” and promising the moon and even the stars. Jamie Thomson, however, was spot-on when he said “decades.” To try to quiet the politics, he even helped invent a way to get ESC from adult skin, but that won’t work until 2010, if then, and, at best, we’ll still be where we are today, which is: ESC have not been involved in any of the about 2000 world-wide stem cell clinical trials, and won’t be tried in one anytime soon.

**To be historically correct, there was one embryonic trial “approved” in January 2009. Don Margolis is on record as saying that trial is a clinical sham and will not start in “early summer 2009 as publicized.”

Are you or a loved one interested in receiving stem cell treatment? For free treatment information, please fill out our treatment form or email me don@repairstemcells.org and just put TREATMENT in the subject box.

Stem Cell Research Paying Dividends to Stroke Patient

Thanks to advances in stem cell research, stroke patients can now be helped with their own Adult Stem Cells. Doctors at University of Texas Medical School in Houston treated a stroke patient for the very first time in the United States  using the patient's own stem cells.

Patient's Own Adult Stem Cells Used for Stroke

Roland Henrich was the first American (in the United States) to be treated with his own Adult stem cells. From the stem cell article:

A University of Texas Medical School at Houston team last week injected stem cells taken from bone marrow of the trial’s first patient (Roland), who arrived at Memorial Hermann Hospital’s emergency department too late to receive tissue plasminogen activator, the clot-busting drug proven to treat stroke if given promptly.

Doctors say Roland is doing well although it is too early to tell if it is because of the stem cell treatment.

Adult Stem Cells for Stroke- Available to the Masses in 2019

Note this date April 1, 2009-- if this treatment using his own stem cells is effective (and it should be) , it will take approximately 10 years before this stem cell treatment becomes available to the general population of the United States because of the FDA's stance that says your own Adult Stem Cells are drugs.

Because- Unfortunately, this is only a part of a  Phase I trial to demonstrate safety-  Savitz said it should take about a year to enroll its 10 patients, who must arrive at Memorial Hermann more than three hours after suffering a stroke but within three days.

This goes to my point about the FDA classifying your own Adult Stem Cells as drugs--

About 1 year to enroll all the patients, another year to follow up on the results, then probably another year before the FDA says "OK, you can do a Phase II trial which will take even longer than the first one--- and if that works out, ok, you can do a Phase III trial.  And then, when that is finally completed, the FDA  may then take their time before approving it as a treatment.   10 years from NOW.  Although the treatment is safe and no side effects because it is your own stem cells.

As I said before here in this post about US Doctors Challenging the FDA , just because it is in the trial phase does not mean it will be able to be used in the United States anytime soon.

Now, I am familiar with stem cell clinics all around the world that are having success using Adult Stem Cells to help stroke patients now.  But because of these ridiculous FDA rules-  Americans will have to wait 10 years for this treatment for stroke.  Think how many stroke victims will needlessly suffer during that time.

Other Stem Cell Therapy for Stroke Stories

This follows that "Stem Cell Tea Bag" that was used to treat (and help) a German stroke victim.

Are you or a loved one interested in receiving stem cell treatment? For free treatment information, please fill out our treatment form or email me don@repairstemcells.org and just put TREATMENT in the subject box.

In another event showing that Adult Stem Cell research in India is truly ahead of the curve,  Adult Stem cells implanted into a woman in a coma from a brain stroke have partially revived her. This stem cell therapy partially waking up a woman is believed to be only the second time in history this has been done with stem cells.

Two years ago, this woman suffered a brain stroke while in a hospital in Sakaal, India. She had been in a coma ever since. Her husband approached a stem cell company in India and asked that she be implanted with her own stem cells taken from her bone marrow. The doctors agreed it could be done and did it.

Here is more from Chaitanya Purandare, the managing director of the stem cell company- Stem One, in India:

The therapy was applied by extracting the patient’s bone marrow stem cells. They were then enriched in the company’s laboratory and injected into the Cerebral Spinal Fluid (fluid present in the spinal cord).

“The dose comprises three injections. After giving injections, the lady, who has been lying still in a vegetative state, has now shown improvements like clenching her fists, turning on the bed without any external support. These may appear too little but for the relatives of a comatose person it is a huge relief,” Purandare said.

Purandare said this therapy does not completely cure a person but helps in improving living condition of the patient. The level of cure also depends on the person’s age and how early the disease is detected.

“This field of treatment is called regenerative medicine. Injecting stem cells into the affected organ revives sick tissues. Like, a patient with spinal cord injury is able to control functioning of bladder. The three doses of injection cost around Rs 80,000. It may sound costly but comparative high expenditure involved in allopathic treatment, this is reasonable. This could become affordable if insurance companies include regenerative treatment in their medi-claim policies,” he said.

Where do I start?  This article and Chaitanya Purandare hit everything right on the head.  A patient with nothing to lose is implanted with her own stem cells and she is improved.  Adult Stem Cells aren't a 100% cure all, but they do help in most cases.  Believe me, these patients and their family members and friends understand and appreciate these victories. If a spinal cord injury patient regains control of his/her bladder thanks to stem cells- that is huge to the patient.

And these treatments probably would save money in the long run.  For example, if a heart patient implants his/her  own stem cells, the resulting benefits may save them from having to implant a pacemaker, may spare them from a bypass, and it may even save them from having a heart transplant-- think how much money would be saved by insurance companies in the long run if this were covered by insurance.

Something to think about....



You can read the full stem cell article here