Researchers at the Stanford Cardiovascular Institute (CVI) have received a National Heart, Lung & Blood Institute grant of over $5 million, to be dispersed over seven years, to conduct clinical trials for stem cell therapy in cardiovascular diseases.
The trials will be the first to involve putting embryonic or induced pluripotent stem cells into human hearts.
“I think this is really an important step in forming a properly designed clinical trial to really find out the effect of stem cell therapy for patients with heart disease,” said Phillip Yang ‘84, professor of cardiovascular medicine and co-principal investigator for the grant.
Previous studies have shown that bone marrow stem cells may improve heart function by helping repair damage caused by various diseases. While heart cells are incapable of independent regeneration, stem cells can function as cardiac cells and thus help treat damaged heart tissue. The trials will build on earlier studies by using pluripotent stem cells, such as embryonic stem cells, which can replicate virtually any kind of cell in the body.
One of the primary goals of the studies is to understand stem cells more fully and why they may be therapeutic, according to John Cooke, professor of cardiovascular medicine and the grant’s principal investigator.
“We want to go beyond looking at ‘yes or no, they are therapeutic’ to ‘what is the mechanism by which they are therapeutic,’” Cooke said.
Researchers will be using imaging technology such as MRIs to track the stem cells after injection and see if they differentiate into cardiac cells and integrate into the heart.
“We’re asking a specific question: ‘do they survive?’” Yang said.
If proven effective, such stem cell therapy could potentially help patients currently awaiting a heart transplant.
“There’s a big supply and demand problem in terms of the number of organs available to treat patients with heart transplants,” said Robert Robbins, director of the CVI and co-principal investigator.
Robbins added that drug complications and organ rejection pose other potential problems with the heart transplant method.
The CVI is one of seven cardiovascular centers around the nation — collectively identified as the Cardiovascular Cell Therapy Research Network — granted over $60 million by the National Heart, Lung & Blood Institute (NHLBI) to perform the clinical trials. The other six centers are located at the University of Florida, the University of Louisville, Indiana University, the University of Miami, the Minneapolis Heart Institute and the Texas Heart Institute.
While similar multi-center studies have been conducted in Europe, this particular clinical trial will be the first of its kind in the United States and is the first such trial to be funded by the NHLBI.
“Many of the stem cell studies that have been done to date have not been well controlled; they’ve been exploratory,” Cooke said. He estimated that adult stem cell therapy will be available to cardiovascular patients within the next five years.
While $3.8 million of the grant has already been issued to Stanford, the remaining funds — an estimated $1.5 million — will be distributed when needed to cover patient and laboratory costs.