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Al

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Doctor restricted after patient reportedly dies from in-office stem cell procedure

By LIZ FREEMAN
Naples Daily News
Posted February 28, 2011

State health regulators have imposed an emergency license restriction on Dr. Zannos Grekos for using experimental stem cell therapy on a breast cancer patient in his Bonita Springs practice last year, resulting in the woman’s death, according to the state’s order.

Grekos is prohibited from providing any stem cell therapy in his practice, and the state will seek a hearing for disciplinary action, according to the Feb. 22 order.

A cardiologist by training, Grekos’ practice is Regenocyte Therapeutic, 9500 Bonita Beach Road, Suite 310.

Grekos’ profile in the community has been high in recent years, as he has held educational forums about stem cell therapy, or using one’s own stem cells to regenerate damaged heart, lung and other tissue. The controversial and expensive treatment is not legal in the United States, and Grekos’ patients historically travel to the Dominican Republic to undergo the procedure.

He also has been the subject of several national media reports in which critics claim there is no clinical evidence of the efficacy of stem cell therapy to repair tissue.

The treatment involves a blood draw, which Grekos does in his office, after which the sample is sent to a laboratory in Israel or elsewhere to be cultivated so the stem cells multiply millions of times. The cultivated stem cells are then sent to a foreign hospital for injecting back into the patient at the site of tissue damage. Some Naples patients have had the procedure done in Bangkok, paying $40,000 or more out of pocket.

“The use of unorthodox stem cell transfusions for diseases that have shown no benefit can be extremely dangerous...” a medical expert retained by the state Department of Health said about the Grekos case involving the breast cancer patient. “I felt that his care was substandard and dangerous.”

Grekos was unavailable for comment Monday and phone calls left with Regenocyte were not returned.

A 69-year-old breast cancer patient, who was not identified by the state, went to see Grekos on Feb. 17 for treatment for neurological damage, namely tingling, numbness and weakness of the extremities. She had undergone six cycles of chemotherapy and radiation for breast cancer diagnosed in 2006.

A few days later, the woman underwent carotid imaging at Grekos’ practice that showed some narrowing of the carotid arteries, according to the state’s report.

On March 24, he performed a cerebral angiogram on the patient, a diagnostic procedure that images the blood vessels of the brain. On the same day, he injected her own aspirated stem cells into her carotid artery to support her brain vessels, according to the report.

The patient was still sedated when she was discharged home that afternoon and was not fully awake. She was carried inside her home where, sometime that evening, she fell and hit her head.

Paramedics were called around 2 a.m. and the woman was taken to NCH North Naples Hospital. A CT scan showed significant swelling of her brain and possible stroke or hemorrhage. She was later transferred to NCH Downtown Naples Hospital for a successful neurological procedure that relieved some of the pressure on her brain.

Another CT scan and multiple MRI’s showed severe brain stem injury and clotting in the woman’s brain. She was taken off life support and died April 4.

The state report said Grekos’ medical records did not justify the injection of the patient’s stem cells for neurological impairment.

The state’s medical expert, who is not identified in the report, offered his or her opinion that Grekos’ care directly led to the patient’s death.

“... I feel the standard of care was far below normal and dangerous, if not criminal. I feel that this practice should be stopped immediately,” the medical expert wrote. “I feel that it is unfortunate that a patient had to die in the state of Florida before attention was brought to this very dangerous, highly experimental, unorthodox, and not scientifically proven procedure.”

According to the state Department of Financial Services, a settlement of $250,000 was paid by Grekos’ insurer for the patient’s death and no lawsuit was filed by the family.




If it can happen here, what do you think is happening in third world countries?
Article from ALS Independence newsletter.

AL.
 
I agree with you, Al, but a lot of folks just don't want to hear that the only "cure" that happens at these places is the augmentation of the quack's bank account with a quick infusion of cash. I'm glad you're keeping up with those stories, though. It's better to be forewarned.
 
Don't forget that Emory and a few other locations are taking a slow and methodical ALS - Stem Cell research approach.
 
Yes, let's hope that Emory does a better scientifical job.
 
Emory's is being monitored by the FDA. That is why they are trying to prove it is safe first. After each group of patients (which is 3 patients) the FDA reviews the data to see if it is safe to proceed. Also each particular case is reviewed by an ethics board at Emory which includes a spouse of a patient who lost their battle with ALS. In order to be eligible to have the surgery the ethics committee reviews and must approve your case first.

I would never pay $40K or any other large sum of money to travel to Bangkok or the Dominican Republic to have this type of experimental procedure done. However this is not costing me a dime Dr. Glass always emphasizes that his first priority is "to do no harm."
 
I find it very disturbing that a treatment that is still only is Phase 1st a top class centre, like Emory, has been used on patients for sometime, in clinics all over the world. No proofof safety, no proof of efficacy. I assure you other people will be dying in some of these clinics. pity international law cannot stop these clinics and close them down.
 
its also sad that some folks will only see that stem cells killed people. they wont look into the details and see that it was done by shady doctors and in a very unsafe way. I pray that it wont ruin it for the doctors that really know what they are doing- like the ones that Ted will be going to. I think there is some real promise here, and it would be a shame for the quacks to ruin it for everyone else.
 
I don't think that the fly-by-nighters will ruin things for the legitimate clinics. After all, although many of us keep up with this sort of thing to keep our hopes up, the overwhelming majority of us are going to look to our ALS clinics for advice on treatments. The doctors at the clinics serve as a screener for the bad and, hopefully, an advocate for the good.
 
I agree, the 2 are worlds apart. There are the true scientists going through the right channels and regulatory authorities, and the people out to exploit and make a fast buck.
At a recent MS meeting I attended, stem cell research was a topic under discussion. The professor leading the session, said that one of the big issues with the use of stem, is that they only survive in our bodies for about 1/2 hour. He also said, that is probably why we have not seen more deaths at the clinics, posing to be legitimate. Many clinics are doing spinal infusions of the stem cells. He thought that if they got to the brain and survived, then the potentially rapid growth of these cells within the brain could possibly cause death. The fact that our bodies destroy them, is keeping the possibly fatal consequences at bay.
He also said that it is hugely promising in the hands of the scientists !
Interesting.
 
Aly, that is the reason why they are putting us on immune suppressing drugs so that are body does not kill them.
 
Thanks for that info Te, I was wondering what they were doing to stop the immune response. It's all very exciting! I hope all goes well with the Emory study. I really admire everyone who takes part in clinical trials. Over the years I have seem compounds move through from phase 2, to the market, where people are benefitting. I have never worked in a centre doing Phase I studies. I imagine it is very intense.
We are just finishing a 4 year oral DMT for MS. The preliminary results might be out for the AAN in Hawaii, I can't wait to see if all our work has been "worth it".
Aly
 
Beware of doctors who are offering stem cell treatments because I just recently discovered this fake doctor. It's on discovery channel. I never knew there are bastardly and pathetic people who would take advantage of the sick and desperate patients just for money.
 
A lot of research is still in the progress for stem cell treatment and I am not sure which ones have come up with a solid result. I have come across this risk and gain assessment of stem cell transplantation in Osteopetrosis. It didn't conclude anything but it does explain how the assessment was done. In general, stem cell transplantation can work well for this disease and should be undertaken if clinically available. Study of osteopetrosis therapies may also have implications for treatment of genetic metabolic diseases and brain-related inherited diseases involving non-malignant neurological deterioration; and a lot research should be inspired with these in hand.
 
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