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Largest long-term stem cell study in cardiology history shows huge increase in quality of life for stem cell patients vs. serious deterioration for standard cardiology.
Mortality reduction of 79% for stem cells vs. pill-takers.
STOCKHOLM -- Injecting autologous bone marrow stem cells directly into the hearts of patients with chronic heart failure appears to improve ventricular performance, quality of life, and survival, according to an open-label, nonrandomized study.
Benefits of the stem cell treatment were apparent within three months -- and persisted for up to five years of follow-up, Bodo-Eckehard Strauer, of Heinrich Heine University of Düsseldorf, Germany, reported at the European Society of Cardiology Congress here.
Patients who did not receive a stem cell infusion and remained on optimal medical therapy continued to deteriorate throughout the follow-up period.
There were no side effects, Strauer said in a "Hot Line" session.
The findings were reported earlier this year in the European Journal of Heart Failure -- a journal of the ESC -- which led the society to bar Strauer from submitting abstracts for two years. Presenting previously-published data broke the rules for "Hot Line" data.
Strauer said at a press briefing that patients with more severe heart failure seem to fare better from the stem cell treatment.
"This therapy has almost no risk. It can only be beneficial in patients. So, in my opinion, it has real clinical importance for the treatment of heart failure," he said.
Rob Califf, MD, vice chancellor for research at Duke University, highlighted the limitations of the study in his comments to MedPage Today:
"God gave us two gifts for doing clinical research -- blinding and randomization," Califf said in an interview. "If you have done neither, your data are interesting but not definitive."
ED NOTE: Dr. Califf is the point man for Big Pharma who will do anything to keep stem cells from interfering with his bosses' profits---including letting you die with his unproven** pills rather than admit over 2500 successfully treated patients around the world means anything. Over 500 of these successes were in USA FDA-approved clinical trials.
** 80% of Califf's drug trials are held in easily-bribed undeveloped countries away from FDA's oversight, according to the SEC and the US Dept. of Justice. Yet the drugs are automatically approved!
Strauer and his colleagues initially approached 391 patients with chronic heart failure resulting from an acute MI to participate in the study -- 191 agreed to receive an autologous bone marrow stem cell infusion, and 200 declined but agreed to participate as controls. The average period since patients experienced an MI was 8.5 years.
Although not randomized, the two groups had similar characteristics at baseline. Mean left ventricular ejection fraction was 29.5% in the treatment group and 36.1% in the control group, but the difference was not statistically significant.
All patients continued to receive optimal medical therapy.
For the bone marrow cell infusion, the researchers harvested stem cells from the patients' iliac crest. Mononuclear cells were isolated and rinsed with heparinized saline.
An average of 66 million stem cells per patient were infused into the infarct-related artery via an angioplasty balloon catheter. Inflation of the balloon simulated an ischemic condition, which prevented back-flow of the cells and provided time for cell migration to the infarct area.
At the three-month follow-up, there was significant improvement in left ventricular performance in the treatment group, reflected by improved cardiac index (by 22%), peak oxygen uptake (by 11%), and oxygen pulse (by 6.3%) (P<0.05 for all).
Exercise capacity increased by 15.4% from baseline, and left ventricular ejection fraction improved from 29.4% at baseline to 36% at three months (P<0.01 for both).
Both end-diastolic and end-systolic volume decreased from baseline in the treatment group (P<0.05 for both).
There were gains in quality of life as well, with the mean New York Heart Association (NYHA) class dropping from 3.22 to 2.25 (P<0.0167). In the control group, NYHA worsened from 3.06 to 3.5.
ED NOTE: NYHA
Class I = Minimum physical effect on the patient from his heart disease, perhaps occasional breathing problem or chest pain.
Class II = Trouble climbing stairs, lifting something heavy, walking quickly, plus general loss of energy.
Class III = Severe physical limitations, constant fatigue.
Class IV = Terminal, heart transplant and hospice are your only options.
The benefits in the treatment group persisted through one and five years.
The control group continued to deteriorate through the follow-up points.
Survival was better in the treatment group than in the control group. Through follow-up, 0.75% of the stem cell-treated patients died each year compared with 3.68% per year among controls (P<0.01).
"The reason [for the mortality reduction] may be twofold; namely, a decrease in pump failure and a decrease in severe cardiac arrhythmias," Strauer and his colleagues wrote in their paper.
Posted:
8/29/2010 7:47:39 PM by
Don Margolis | with
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Eight years ago, the rotator cuff on Tom Novak’s left shoulder tore.
After surgery to repair the injury and the biceps tendonitis that came with the tear, Novak underwent six months of physical therapy to regain proper motion. Then this year, the same thing happened again – this time to his right shoulder.
“It was probably a combination of wear and tear and throwing around 50 pound bags,” the 70-year-old Southport resident said, recalling the sharp, shooting pain that ripped though his arm one afternoon in June when he was working around the house.
“I realized something had gone wrong because I couldn’t pick up the drill,” he said. “I could not lift my hand higher than my waist.” But this time around after the surgery, Novak the recovery was noticeably different.
Within days he no longer had to take pain medication, and in a few weeks he regained the same range of motion it took months of physical therapy to achieve last time.
“Eight years ago, they were doing things differently,” Novak said. This time, Novak’s orthopedic surgeon Austin Yeargan tried a new approach. Yeargan harvested adult stem cells from bone marrow that came from Novak’s hip and used them to help repair his rotator cuff, combining it with a process to bathe the surgical site with platelet-rich plasma to jump-start growth factors.
“What I’m most excited about is using it for rotator cuff procedures. There are 15 percent of people who still do not do well after the surgery,” said Yeargan, who is based in Southport but operates in Brunswick County and Wilmington. “What I’m hoping is it helps to heal in cases when it’s older adults who don’t have the best tissue in the world.
“I’m going to start using it too for the bad fractures where the bone is very poor.”
Because adult stem cells do not have a specific structure or function, they are showing promise in a range of different types of surgeries to aid the healing process.
“The stem cells, they’re the most important thing because they’re not differentiated. They can really do anything,” Yeargan said.
Sidestepping the controversial issue of embryonic stem cell use, researchers have looked at new ways to use stem cells taken directly from the patient.
Yeargan pointed out that there needs to be more studies published using controlled groups to back up the procedure.
“Anecdotally, I have noticed a far quicker recovery and less pain,” he said.
Philip Hardison, president and CEO of the Wilmington-based Synergistic Technologies company that distributes the equipment for the process and has been marketing it to area surgeons, said the approach also has been used locally for spine fusions to grow bone after spine surgery.
He pointed to other areas of the country where the patient’s adult stem cells have been used to treat chronic wounds that won’t heal and for peripheral artery disease.
Last year, researchers in Ohio published the outcome of a clinical trial during which six of nine patients with severe peripheral artery disease who received adult stem cell transplants avoided major amputation. The stem cells helped grow new blood vessels to bypass damaged ones.
Blood vessels, however, are not the only thing adult stem cells could be used for as the building blocks for new growth. “If you put them (the adult stem cells) in the knee, where you typically have bone on bone, it will regrow the cartilage, which will prevent someone from having a total knee (replacement) surgery or at least buy them some time,” Hardison said. “Right now, we’ve been using it in orthopedic and spine surgeries, but the next level is with some of the trauma surgeons and to avoid amputations.”
FROM DON MARGOLIS: This doctor took a major step forward but will be stopped by the FDA, as all good doctors are who actually try to help people with the only stem cells which work. NOT because they are unsafe but because Repair Stem Cells threaten the profits of the Big Corporations who own our government and the FDA. There are two little companies in the USA which do what this doctor did without the surgery. The FDA is, of course, doing its best to destroy stem cells which help people and has come up with a new law to close one of them down. If you don’t know this by now, learn it:
Rule #1 of medicine in North America is profits to the big guys come first.
Rule #2 no cures of chronic diseases allowed---EVER, since cured patients cannot contribute to profits.
Rule #3 Patients are profitable Lab Rats, nothing more. Allow drugs which kill by the thousands but not stem cells which can’t kill anyone.
Posted:
8/27/2010 5:05:18 AM by
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Marine Corporal “First to Get New Procedure” for spinal cord injury
While 2000 SCI patients around the world have had Adult Stem Cells implanted in the past 8 years, it is sad to know how many Americans are being fooled. Every time someone is treated in the USA with stem cells (for any disease) the press releases and newspapers always call it a “first” when 100% of the time it is not.
The first patient to undergo an adult stem cell procedure that may help spinal cord injury patients regain function had an injection Thursday that may change the course of medical history.
That’s the nonsense given to medical reporters at every major USA newspaper, and they always go for it! Fortunately for the patient, his procedure is long-proven and his chances for success are about 65%.
Sitting in his den Thursday morning, surrounded by pictures of Dr. John, Matt Cole, the patient, was cool, calm and collected. His wife Kim was with him, and he answered questions for documentation of the medical procedure he was about to undertake – an injection of his stem cells into his spinal cord that may help him regain use of his lower body.
Cole, 30, was injured in Iraq during his second tour of duty. A corporal in the U. S. Marine Corps, his day of infamy was May 17, 2005. Insurgents attacked with mortars and rockets and he was hit with shrapnel in the back and right lung. As a result, he suffered a spinal cord injury and a collapsed lung.
His was treated on the site by corpsman and then flown to a MASH unit. There he was put under, stabilized and sent to a hospital in Germany. “I was supposed to die,” Cole said.
Four days later he was flown from Germany to the Bethesda Naval Hospital in Maryland and later he went to the Veterans Administration Hospital in Tampa for rehab and physical therapy.
His long, grueling road back included physical therapy, occupational therapy, recreational therapy and learning how to adjust to his new life—in a wheelchair.
He learned how to get off the floor, how open and close doors and how to get from the bed to the wheelchair, among other tasks.
Through it all, his mother Diane said, “He kept in good spirits and has never been anything other than positive.”
He said, “Kim was the first one to the hospital and has stayed by me ever since.” They were dating at the time and are now married, expecting their first child. Kim is an adaptive physical education teacher for St. Tammany Parish.
Conscientious about his physical therapy, Cole has continued exercising and keeping himself fit, hoping that one day he would be able to find a medical solution that would help him get out of the wheelchair.
“Keeping a positive attitude is key, along with a strong faith in God and staying in shape. You can really fall into a hole, so it’s important to remain positive and keep up with what’s out there in research, anything that can improve your quality of life,” said Cole.
FOR THE FULL ARTICLE
http://www.slidellsentry.com/articles/2010/08/22/news/doc4c6f0c1e68252936100930.txt
Posted:
8/27/2010 5:02:38 AM by
Don Margolis | with
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A SEVERELY-DISABLED boy could already be showing signs of improvement after undergoing groundbreaking stem cell therapy in Germany.
Callum Miller, five, has just returned from the XCell Center, at the Institute of Regenerative Medicine clinic, in Cologne, where he had a procedure which could help improve his quality of life.
Callum, a pupil at the Pioneer School,
Basildon,
is unable to move his arms or legs, hear, or swallow after being born with severe brain damage. He also has cerebral palsy and is epileptic.
The therapy saw stem cells being taken from Callum’s hip bone and then re-inserted into his spine.
Although it is too early to tell if it will have a long-lasting effect, Callum’s mum, Jane Morgan, is thinking positively.
Jane, 33, of Bourne Close, Laindon, has been fundraising for two years to raise the £9,000 needed for the treatment.
The single mum said: “We won’t know if there’s been any big improvement for about three months or so, but already I think Callum is showing some sign it has worked.
“There’s something different about his eyes, as though he is more aware of things going on around him.
“If we see some amazing changes, I will be shouting it from the rooftops.”
The treatment has a success rate of 67 per cent in children with Callum’s disabilities.
Some children having stem cell therapy end up being able to move their limbs or even to see and hear.
Jane said: “We had to try. If it works or not, it’s something, as a mother, I had to do for Callum.”
The XCell Center is the world’s first private institution licensed to carry out the stem cell treatment Callum needed.
Jane said: “It was an amazing place. There were families there from all over the world. We met people from Egypt, America and from the UK, all hoping for the same results as us.”
Callum’s brother Connor, aged seven, was on hand to support the boy.
Jane said: “Connor is an amazing brother to Callum. He loves him so much. After the stem cell procedure, he sat with Callum next to his bed and showed him his cuddly toy, Woof Woof, to cheer him up.”
A friend of Jane’s is organising a charity football match in aid of Callum’s cause, at the James Hornsby School, in Laindon, at 12.15pm on Saturday.
Jane said: “We may have to go back to the clinic for further procedures so it’s important to keep fundraising. People have been incredibly supportive so far and we are very grateful.”
Posted:
8/27/2010 4:56:53 AM by
Don Margolis | with
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Though nowadays Big Pharma, Mainstream Media, and Embryonic Stem Cell lobbies have tried to suppress offshore stem cell treatments, VesCell has pushed onward as clinical trials, patient needs, and success in over 500 patients cannot be silenced. Ron discovered VesCell online, and like hundreds before him, he is now living a far more normal life.
Premature Ventricular Contraction (PVC) means your heart skips a beat and then resumes beating normally until a minute or so and skips again, in his case thousands of times a day. His symptoms included congestive heart failure and non-ischemic cardiomyopathy. His ejection fraction had dropped to 25% and he suffered shortness of breath at times. To combat his valvular heart disease, Ron received both the Maze Procedure and a bovine mitral valve replacement in December, 2003, but his PVC and palpitations continued to be bothersome and getting worse.
The North Carolina cardiomyopathy patient was told by his cardiologist that there was nothing he could do about his PVC and his 25% ejection fraction. Ron, at 62 decided that he no longer wished to suffer thousands of palpitations a day, not to mention occasional shortness of breath. In a word, he simply was not getting better, he was getting worse.
In April, 2010, he took the advice of an acquaintance and made the trek to Bangkok as over 250 American heart patients had before him, and fortunately, he joined the 70% of them who went on to a better quality of life.
“At the two-month mark, I suddenly realized that the PVCs had dropped from thousands to just a few a day. Just as importantly, my energy is up and that I can feel every day now. I was depressed as a no-hope patient, but after talking to my Bangkok cardiologist, I realize how misinformed I had been. My positive attitude today reflects that.”
Ron continues to improve, and looks forward to sharing his experiences with future adult stem cell patients.
VesCell™ uses a patient’s own adult stem cells to treat Heart Disease and is a viable alternative for patients who either cannot undergo or choose not to undergo the standard treatment such as Coronary Artery Bypass Grafting (CABG), heart transplants, or receiving maximal therapy. The company focused on using stem cells from the patient’s own blood in order to treat cardiovascular diseases.
Posted:
8/14/2010 11:06:10 AM by
Don Margolis | with
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