Patients Reunite to Celebrate Six Years of ISCI Clinical Trials

Several years ago, Deborah Wilson suffered a debilitating heart attack that left her so weak even getting up from a chair left her winded. But now, the 63-year-old woman is doing water aerobics, dancing and even bowling again. She also got to see the birth of her great-grandson.

“I am doing things again I wouldn’t even have thought about doing a few years ago,” said Wilson. “There was a time I couldn’t do anything unless I had assistance.”

Wilson credits her renewed vigor to the stem cell therapy she received four years ago as part of a cardiac stem cell clinical trial conducted by the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School of Medicine. She was one of nearly 60 patients who gathered together recently to celebrate the sixth anniversary of patient clinical trials at ISCI.

The 2014 Interdisciplinary Stem Cell Institute Patient Reunion was held on October 27 at the University of Miami Hospital. Musical entertainment was provided by patient David Donahue, as the guests and their families caught up with one another and enjoyed lunch.

Joshua M. Hare, M.D., ISCI’s founding director, said patients, faculty and staff have all contributed to make a major impact in the field of regenerative medicine.

“This is a special event for everybody in the room,” said Hare, who is also the Louis Lemberg Professor of Medicine, and Chief Sciences Officer. “This event celebrates the work we have been doing in stem cell research, and many of you here have been through our protocol. The fact that you are here today is a testament to the importance of the work we are doing.”

Since 2008, the team at ISCI has completed four cardiac stem cell clinical trials, which showed exciting results treating heart disease. The studies have led to the development of several new studies using stem cells to treat some of the most chronic and debilitating diseases, including lung disease, aging frailty, and Crohn’s disease.

ISCI is also collaborating with the University of Maryland on the nation’s first-ever study using stem cells to treat infants with congestive heart disease, and their research continues to be published in top scientific journals.

“The biggest impact on medicine for the 21st century, make no mistake, will be the advancement and use of stem cells for illnesses for which, up to now, there has not been a treatment,” said Pascal J. Goldschmidt, M.D., Senior Vice President for Medical Affairs and Dean of the Miller School of Medicine, and CEO of the University of Miami Health System. “Now stem cell therapy will become the treatment of choice. Josh Hare and his team are at the forefront of this groundbreaking work.”

Alan W. Heldman, M.D., Director of UM’s Comprehensive Program in Regenerative Medicine at ISCI, said all thanks are due to the patients who showed tremendous confidence in the medical team by participating in the potentially revolutionary, investigational therapy.

“This is about the patients, who set out on a research journey with us,” said Heldman, who is also professor of medicine, Director of Interventional Cardiology, and holds the Elaine and Sydney Sussman Chair in Interventional Cardiology. “They are pioneers because this is very early stage, and very substantial research from them to attempt to learn with us whether we can treat heart disease with stem cells. The successes that we have enjoyed, and they have been considerable, and the academic output and positive findings from our studies are all because of the patients who trusted us.”

A reading of a poem written by patient David Serkez, called And the Beat Goes On, set the stage for the speakers. Each spoke from the heart about their experiences with the ISCI team.

Edgardo Irastorza is the youngest patient in the program. At just 31 years old, and with his wife pregnant with their third child, Irastorza’s heart twice stopped beating. Doctors were able to resuscitate him, but he was left with a badly weakened heart that made it nearly impossible to live a normal life.

He admits he would go to sleep not knowing if he would wake up in the morning. But that changed, once he took part in the clinical trial at ISCI.

“Stem cell therapy extended the time of my life,” Irastorza said. “I would not have been able to see my third son born, if not for this. I get to play with my kids. I get to do all of the things that young people get to enjoy, and I really did not have that for a year and a half.”

Donna Diamond also turned to the team at ISCI, after learning she would need a heart transplant two years ago. Since then, she has had stem cell therapy, and is able to be as active as she wants to be.

“I just want to say I was the luckiest person in the world,” said Diamond. “I want to thank Dr. Hare and his whole team. I am thrilled to be here.”

ISCI has treated 140 patients over the course of their clinical trials. Darcy DiFede, Director of Research at ISCI, said their work requires the commitment of a team of people, all of whom focus on making the patients their Number One priority.

“Today is all about us bringing the patients together and giving them a ‘thank you’ for participating in the stem cell program,” said DiFede, R.N., BSN. “Many of these patients have been with us for seven years. They were true pioneers when we did our first open heart delivery system of stem cells and they are still here today, and doing phenomenally well.”

The luncheon was also an opportunity to pay tribute to two members of the ISCI clinical trial family. DiFede and Hare honored cardiothoracic surgeon James Symes, who passed away earlier this year. Hare remembered Symes, who was professor of surgery at the Miller School of Medicine and Chief of Cardiothoracic Surgery at the Bruce W. Carter VA Medical Center, as an integral part of the ISCI team.

“He was an amazing colleague to work with,” Hare said. “He was incredibly enthusiastic, along with his partners, about the work we are doing. He went to extreme lengths to help the project and make it work.”

A memorial plaque was also presented to the family of Felix Morales, an ISCI patient who passed away in September at the age of 83. His daughter, Veronica Morales-Garcia, said her father suffered from heart disease for decades. But after receiving stem cell treatment in 2009 as part of ISCI’s NIH-funded POSEIDON trial, he was able to return to his favorite hobbies, and lived long enough to meet his first grandchild, Isabella.

“It is a privilege that my dad was part of this group,” Morales-Garcia said. “I honestly think it extended his life. He loved this group so much. They gave him the gift of life.”

A photo of Morales’s heart, before and after stem cell therapy, was used on the cover of Circulation Research to illustrate a successful case of stem cells reducing scar tissue, in Morales’s case, up to 50 percent.

“I don’t have the words to express my gratitude to every member of the staff for giving us Felix for five more years,” said wife Maria Morales. “It was so important to us. God bless them all, and I hope they continue with their research. It is really the way to go.”

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