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Cardiac Stem Cell Patients Hailed as ‘Pioneers’

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    Joshua M. Hare, Juan Pablo Zambrano, Alan Heldman, and Darcy Velazquez watch as patient Edgardo Irastorza shows off his break-dancing moves.

    When Edgardo Irastorza started feeling out of breath, with blurry vision and numbness in his legs following a workout, he knew something was wrong. Rushed to the hospital, he says he “flatlined” and had to be revived. Doctors told him he had suffered a massive heart attack due to a major blockage in a coronary artery, called a “widow-maker.” A huge amount of heart tissue was damaged due to the heart attack. That was October 2008. He was 31 years old, with a wife expecting their third son.

    Irastorza told that story to more than 100 people Friday, April 29. He was one of 51 patients gathered for a special luncheon held to thank all those who have participated in cardiac stem cell trials at the Interdisciplinary Stem Cell Institute at the Miller School of Medicine. The luncheon, held at University of Miami Hospital, the flagship hospital of UHealth-University of Miami Health System, honored what is believed to be the largest group of patients in the U.S. enrolled in cardiac stem cell trials.

    Joshua M. Hare, director of the institute, told the patients they each “had the heart of a pioneer.” In thanking them for participating in the studies, Hare highlighted their courage, patience, and generosity in partnering with the stem cell team. “Without you, we would never know whether stem cell therapy works.”

    Irastorza enrolled in one of the trials after seeing a story about another stem cell patient. He took part in the TAC-HFT trial, a double-blind, placebo-controlled study examining the safety and efficacy of injecting either bone marrow or a patient’s mesenchymal stem cells (MSCs) following a heart attack. Seven weeks later, Irastorza was back to break-dancing, a favorite hobby and one that he shared with the crowd through a video.

    The father of three became emotional and drew a standing ovation when he talked about placing himself in “the hands of the finest medical team. The results have changed my life. I can rest my head on my pillow and know I’ll wake up the next day.”

    David Serkez had a heart attack at the age of 43. He also participated in the TAC-HFT trial, which is still enrolling patients. Serkez said “words can’t express how I feel,” and then added that he was “so grateful to be standing and talking.”

    Hare and the patients in the TAC-HFT trial won’t know whether they received stem cells or bone marrow until all the data is completed. Meanwhile, the physicians and scientists are currently processing the results of another trial where patients were injected with MSCs or bone marrow during open heart surgery. Hare says using double-blind studies will ensure they examine the data objectively. “It’s the only way to scientifically and ethically determine whether stem cell therapy is better than current treatments.”

    Deborah Wilson Witt, another TAC-HFT enrollee, might not know what her injection contained in February 2010, but she’s certain her life has changed. She told the guests and fellow patients she feels “energized, revitalized, and restored.” She thanked Hare for his passion and for “believing in what he’s doing.”

    Yet another trial has been approved and is expected to begin enrollment in June. The Poseidon DCM will be a study comparing autologous MSCs to allogeneic (belonging to a donor) MSCs in patients with dilated cardiomyopathy.

    Since April 2008, when the first enrolled patient was injected as part of the cardiac stem cell trials at the Miller School, Hare and his team have published two studies indicating that mesenchymal stem cells have the ability to improve cardiac function and even repair damage to the heart muscle.

    A key member of the institute, Alan Heldman, professor of medicine, works to navigate the heart to determine the best way to deliver the stem cells to the damaged area. He thanked the patients for believing in them, for making their “personal dedication and enduring the uncertainty.”

    Hare and Heldman came to UM from The Johns Hopkins University in 2007 because, they say, of the vision of Miller School Dean Pascal J. Goldschmidt. Thanks to his support and that of University of Miami Hospital, “UMH is second to none,” Heldman said.

    They also thanked William O’Neill, executive dean for clinical affairs and world renowned interventional cardiologist, who delivered the closing remarks. O’Neill said he wished Hare and Heldman had been around at the time his father had a heart attack at age 47. But the day was about the patients, who O’Neill said “are true heroes who took a leap of faith.”

    Darcy Velazquez, clinical coordinator who worked closely with each of the patients, said,  “Today is the day our pioneers made history.”


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