Mayo Clinic wins FDA approval to test stem-cell heart therapy

January 20, 2014 by Dan Browning

A decade-long Mayo Clinic research project on using stem cells to repair damaged heart tissue has won federal approval for human testing, a step that could have implications for millions of Americans with heart disease.

The U.S. Food and Drug Administration has approved a multistate clinical trial of 240 patients with chronic advanced symptomatic heart failure to see if the new procedure produces a significant improvement in heart function, Mayo officials announced Friday.

Safety testing in humans, completed earlier in Europe, showed a preliminary 25 percent improvement in cardiac outflow, according to Dr. Andre Terzic, director of the Mayo Clinic's Center for Regenerative Medicine.

The procedure could be a "paradigm shift" in the treatment of heart disease, Terzic said.

Going forward, he said, treatments won't just focus on easing the symptoms of , but rather on curing it.

The process, developed in collaboration with Cardio3 BioSciences of Belgium, involves harvesting stem cells from a patient's bone marrow in the hip, directing the cells to become "cardiopoietic" repair cells, then injecting them back into the heart to do their work.

Mayo researcher Dr. Atta Behfar and other members of Terzic's team isolated hundreds of proteins involved in the "transcription" process that takes place when stem cells are converted to . They identified eight proteins that were crucial, and used them to convert into cells.

"This is unique in the world," Terzic said.

Dr. Ganesh Raveendran, a cardiologist and co-director of the University of Minnesota's cardiac cell therapy program, called the Mayo research encouraging, but advised caution. Raveendran said a variety of small stem cell studies have shown mixed results, but when the treatments were tested in larger studies, they showed no beneficial effects. "We need to wait and see," he said.

For now, 40 hospitals in Europe and Israel are enrolling patients in human trials to test the Mayo procedure. Enrollments are expected to be completed by the end of the year, and early results should be available in 2015, according to Dr. Christian Homsy, CEO of Cardio3 BioSciences.

If things go well, patients in Europe could start being treated with the new technology by the end of 2016, and perhaps a year later for patients in the United States.

Homsy said more than $110 million has been spent in Europe developing and testing the process, and that he expects his company to increase its presence in Rochester, Minn., to work more closely with Mayo researchers there.

"Our collaboration with Mayo has been so productive that we have many, many opportunities that we'd like to explore," Homsy said.

Mayo researchers are working on similar "" projects involving many other ailments, including diabetes, diseases of the liver and lungs, neurological disorders and orthopedics, Terzic said.

"Cardiovascular disease may be the beginning of a ... a magnificent journey of addressing various diseases that humankind is confronting, especially with the aging of the population," he said.

Explore further: Regenerative medicine: Researchers develop new tool for transplanting stem cells

Related Stories

Regenerative medicine: Researchers develop new tool for transplanting stem cells

December 16, 2013
Mayo Clinic researchers and colleagues in Belgium have developed a specialized catheter for transplanting stem cells into the beating heart. The novel device includes a curved needle and graded openings along the needle shaft, ...

Mayo Clinic restores disrupted heartbeat with regenerative intervention

September 3, 2013
Mayo Clinic researchers have found a way to resynchronize cardiac motion following a heart attack using stem cells. Scientists implanted engineered stem cells, also known as induced pluripotent stem (iPS) cells, into damaged ...

Cardiopoietic 'smart' stem cells show promise in heart failure patients

April 10, 2013
Translating a Mayo Clinic stem-cell discovery, an international team has demonstrated that therapy with cardiopoietic (cardiogenically-instructed) or "smart" stem cells can improve heart health for people suffering from heart ...

New way to weed out problem stem cells, making therapy safer

September 27, 2012
Mayo Clinic researchers have found a way to detect and eliminate potentially troublemaking stem cells to make stem cell therapy safer. Induced Pluripotent Stem cells, also known as iPS cells, are bioengineered from adult ...

Mayo Clinic first in US to test stem cells in pediatric congenital heart disease patients

June 11, 2013
Mayo Clinic has announced the first U.S. stem cell clinical trial for pediatric congenital heart disease. The trial aims to determine how stem cells from autologous umbilical cord blood can help children with hypoplastic ...

Researcher to grow human cells in space to test treatment for stroke

December 19, 2013
Abba Zubair, M.D., Ph.D, believes that cells grown in the International Space Station (ISS) could help patients recover from a stroke, and that it may even be possible to generate human tissues and organs in space. He just ...

Recommended for you

Starting periods before age of 12 linked to heightened risk of heart disease and stroke

January 15, 2018
Starting periods early—before the age of 12—is linked to a heightened risk of heart disease and stroke in later life, suggests an analysis of data from the UK Biobank study, published online in the journal Heart.

'Decorated' stem cells could offer targeted heart repair

January 10, 2018
Although cardiac stem cell therapy is a promising treatment for heart attack patients, directing the cells to the site of an injury - and getting them to stay there - remains challenging. In a new pilot study using an animal ...

Exercise is good for the heart, high blood pressure is bad—researchers find out why

January 10, 2018
When the heart is put under stress during exercise, it is considered healthy. Yet stress due to high blood pressure is bad for the heart. Why? And is this always the case? Researchers of the German Centre for Cardiovascular ...

Two simple tests could help to pinpoint cause of stroke

January 10, 2018
Detecting the cause of the deadliest form of stroke could be improved by a simple blood test added alongside a routine brain scan, research suggests.

Heart-muscle patches made with human cells improve heart attack recovery

January 10, 2018
Large, human cardiac-muscle patches created in the lab have been tested, for the first time, on large animals in a heart attack model. This clinically relevant approach showed that the patches significantly improved recovery ...

Place of residence linked to heart failure risk

January 9, 2018
Location. Location. Location.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.