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Jeannine
04-30-2011, 07:43 PM
Note: Even with such good results, the last paragraph states it will still take the FDA 3 to 5 years to approve this treatment for the general public. All I can say is why?

Stem Cell trial volunteers thank doctors at reunion lunch
More than 50 patients reunited Friday to thank doctors who are treating them in a new series of clinical trials at University of Miami by injecting stem cells into their damaged hearts to heal them. Optimism reigned, although final results are years away

By Fred Tasker
ftasker@MiamiHerald.com
One by one, the patients approached heart doctor Joshua Hare and his surgical team at the reunion luncheon Friday, hugging them, pumping their hands, thanking them for saving their lives.

“I believe in miracles, God — and my doctors,” said Edgar Irastorza, 33, the youngest of 51 patients at the luncheon.

It’s not that simple, of course. Final results are a year or more away in the five clinical trials that have given the patients such hope. They’re among 70 volunteers in trials at the University of Miami Miller School of Medicine in which adult stem cells are injected into dead scar tissue in their hearts in hopes of creating new, healthy heart cells.

If it works, doctors say it would be the first instances of healing human hearts damaged by heart attack, congestive heart failure, genetic flaws and other causes. They hope someday it can prevent the need for most heart transplants.

Early results are promising, says Hare, director of UM’s Interdisciplinary Stem Cell Institute.

“We don’t know what the results will be, but things are going well. The fact that you’re here is testament to that,” he told the patients, united for the first time at a luncheon titled “Heart of a Pioneer” to celebrate their struggle.

At the luncheon, the patients related their stories.

Irastorza, a Miami property manager, said he died briefly on Oct. 6, 2008. A genetic defect gave him such a serious heart attack that his heart stopped for a few minutes. Doctors who revived him said half his heart was dead and warned him to prepare for a short, disabled life. They wanted to insert a defibrillator into his chest.

“I didn’t want that,” he said. “I didn’t want to give up sex and dancing.”

On March 3, 2010, UM doctors used a catheter inserted through a slit in his groin to inject millions of tiny stem cells into his damaged heart.

At the Friday luncheon, Irastorza showed the crowd a five-minute video of his new self, doing an energetic, head-spinning break dance.

“I’m not completely back to normal, but, compared to before, it’s night and day,” he said.

Felix Morales, 80, a retired state agriculture worker, had a heart attack 25 years ago and recently had become too easily fatigued to take care of the collards and peppers and the mamey and mango trees in his Miami backyard.

A year ago, he got one of the stem-cell treatments.

“It took a while, but I feel good right now,” he said. “I have no words to express my gratitude.”

Morales got stem cells from a donor. He’s part of a trial in which researchers are comparing the value of using donor cells to using only the patient’s own stem cells harvested from his or her own bone marrow.

Evangeline Gordon, 40, a retired state probation officer from Miami, called 911 one October night in 2009, thinking she had a bad gas attack. To her shock, doctors told her a heart attack had damaged 70 percent of her heart muscle. They began discussing a heart transplant.

Instead, she volunteered for the UM program and got stem cells from a donor. Like most of the others, she doesn’t know if she got real stem cells or a placebo treatment used for comparison.

“I’m up and down,” she said Friday. “I still get angina and fatigue, but I don’t feel like I’m going down anymore.”

The clinical trials are based on the fact that a person’s bone marrow contains millions of tiny stem cells that are undifferentiated, meaning they can still be guided to turning into other kinds of cells — blood, heart or brain tissue.

In the earliest trials, the stem cells were injected directly into the patient’s heart during open-heart bypass surgery. In more advanced trials, the stem cells were injected into the heart through a catheter that entered the body through a slit in the groin and went up the femoral artery into the heart. Drs. Alan Heldman and Juan Pablo Zambrano did much of the insertions for the trials.

Under FDA rules for “double-blind” clinical trials, some participants got real stem cells, others got placebos for purposes of comparison. Most won’t find out which they got until the end of the trials in 2012.

Hare, who has been working on the process since 2002, has one clinical trial completed and published, three more under way and he announced a new one on Friday.

The trials already have demonstrated that stem cells injected into the heart were able to differentiate themselves into heart cells, and to stimulate the heart to create new cells of its own. Patients achieved better heart function, more energy and less pain.

Another trial compares the viability of stem cells taken from the patient’s own bone marrow to stem cells donated by another person. If donor cells can be used without being rejected by the patient’s body, it might be possible to store stem cells on the shelf awaiting quick use in new heart-attack victims, Hare says.

Final FDA approval and general use of the stem cell therapies is three to five years away, Hare said. Researchers hope the process also can be used for other organs including liver, kidney and pancreas.

“It would be the Holy Grail,” he said.

Read more: http://www.miamiherald.com/2011/04/29/v-fullstory/2193087/stem-cell-trial-volunteers-thank.html#ixzz1L3pUOMek