Dr. Marilyn Glassberg Presents Findings on Stem Cell Treatments for Lung Diseases

Marilyn K. Glassberg, M.D., professor of medicine, surgery and pediatrics at the University of Miami Miller School of Medicine, spoke recently at an international health care conference held at the Vatican.

Glassberg, who is also director of the Interstitial Lung Disease Program and director of pulmonary diseases at the Interdisciplinary Stem Cell Institute, was the only lung disease expert in the world invited to speak at “Unite to Cure: A Global Health Care Initiative.” Her presentation was part of “The Pharmacy of the Future – Cardiovascular, Pulmonary and Neurodegenerative Diseases,” a panel discussion moderated by medical journalist Sanjay Gupta, M.D.

It was the Vatican’s fourth international conference on regenerative medicine, and the second at which Glassberg had spoken. She joined an international group of experts from a variety of disease fields.

Glassberg began her presentation discussing idiopathic pulmonary fibrosis (IPF), an incurable lung disease. She is one of the world’s leading authorities on IPF.

“This disease likely begins as an inflammatory process,” she said. “What happens to patients is, as time progresses, they can’t breathe any more. They become dependent on oxygen, they become respiratory cripples, and they die. They die fairly quickly — usually within three to five years. But behind the scenes is a very complex pathway that we are only beginning to understand.”

Glassberg noted that there are only two drugs approved to treat IPF, neither of which is a cure. In 2013, in a search for new directions, she began exploring using mesenchymal stem cells in therapies for chronic lung diseases in collaboration with Joshua M. Hare, M.D., director of the Interdisciplinary Stem Cell Institute, and the Louis Lemberg Professor of Medicine. By 2017, she had conducted and published a small human clinical trial that enrolled 11 idiopathic pulmonary fibrosis patients, nine of whom were treated and seven of whom completed follow-up.

During the 60-week trial — the longest such trial ever conducted in human subjects — the patients were divided into three groups. Each group received one dose of 20 million, 100 million or 200 million mesenchymal stem cells from healthy bone marrow donors. The trial demonstrated the safety of the treatment. It also demonstrated some resulting stability in certain lung function measurements, although results varied among the cohorts. Follow-up CT scans showed reduction in both inflammation and fibrosis. Glassberg and her team have now applied for funding for a Phase 2 multidose study of 21 patients.

With safety proven, they have already received funding for three additional studies of stem cell therapies for other lung diseases and lung transplantation.

“CELEB, which has completed enrollment, studies the safety and potential efficacy of mesenchymal stem cells in patients with non-cystic fibrosis bronchiectasis,” said Glassberg. “This is a chronic inflammatory disease with infection, and mesenchymal stem cells have potent effects on infection and on bacteria. It’s a safety study that will then move on to a multi-center study to determine the best source of stem cells and the right dose.

“ASTEC, which is currently enrolling, will study mild-to-moderate asthmatics, once again driven by our interest in inflammation.

“BOSS will study lung transplant patients. These patients have a five-year, 50 percent survival rate, but they all ultimately develop rejection of the transplanted organ. We spend hundreds of thousands of dollars to transplant them, and they don’t perform well, so we’re looking for something that may positively affect their outcome. There has been a small, preliminary safety study that looks to be of some benefit.”

The other panelists were Jan-Eric W. Ahlfors, CEO and chief scientific officer of Fortuna Fix, and Douglas W. Losordo, M.D., senior vice president of clinical, medical and regulatory affairs, and chief medical officer of Caladrius Biosciences, both clinical-stage regenerative medicine companies. Losordo is also clinical professor of medicine at the New York University Langone Medical Center and adjunct professor of medicine at the Northwestern University Feinberg School of Medicine.

“I am extremely proud to have been invited to speak, and to represent the Miller School, at two of the Vatican conferences,” said Glassberg. “I hope to come back in two years to report on groundbreaking therapies for patients with presently untreatable chronic lung diseases.”

A video of the panel discussion can be seen above. Glassberg gave the first presentation, and she answered follow-up questions from Gupta immediately afterward and at the very end of the panel discussion.

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