Mayo Clinic Gets FDA Approval for Stem Cell Trial

Updated: 01/17/2014 6:16 PM
Created: 01/17/2014 5:37 PM
By: Katie Eldred

(ABC 6 NEWS) -- Treating failing hearts with super strength stem cells in now one step closer to being a reality. Mayo Clinic announced Friday that the FDA has approved a clinical trial for their cardio stem cell therapy.

Mayo Clinic Dr. Andre Terzic says the trial could change the way we treat many health conditions.

"Regenerative medicine is the future of medicine," said Dr. Terzic.

After ten years of research, the FDA’s approval of the clinical study for them to test their stem cell therapy treatment on heart failure patients is the final stage.

"We are increasingly learning that injecting stem cells, that the heart doesn't remain passive, but actually starts participating into its own ability to heal," said Dr. Terzic.

Mayo Clinic held a press conference Friday with their research partner Cardio3 BioSciences out of Belgium. The phase three trial will test their perfected cadiogenically instructed stem cells.

Christian Homsy says they've already seen the cells work wonders.

"We've had what's called a phase II trial, which is a safety and feasibility trial, we've actually seen a 25 percent increase in the cardiac function of those patients, in other words the capacity of the heart to pump blood," said Dr. Homsy.

The U.S. trial will consist of testing 240 heart failure patients.

"It opens the door to a new approach to medicine to be able to heal the heart, as opposed to treating it's symptoms," said Dr. Homsy.

If all goes as planned, the trial could lead to using similar treatments for other health conditions.

"The experience that is being built will be most useful for the cardiovascular base ,but also beyond the heart," said Dr. Terzic.

After years of hard work they are excited to be so close to offering the life changing treatment to all patients.

"For us it's been an eternity, we’re seeing patients doing better and we want to get that treatment to the others as soon as possible," said Dr. Homsy.

"The excitement not just to be able to offer it to patients in early studies, but now these final validating studies are the ultimate dream and we are definitely there now," said Terzic.

The trial and it's results will most likely take up to two years. But heart disease patients could be treated by the stem cell therapy as soon as 2016.