Researchers at Intermountain Medical Center have launched a safety study of an investigational adult stem cell treatment that may repair kidney damage suffered during heart surgery.

The phase 1 safety clinical trial brings the heart surgeons at IMC together with biotech company AlloCure to use mesenchymal stem cells, which are found in adult bone marrow, to tackle one of the serious potential complications of open-heart and other major surgeries.

Any major surgery puts great stress on the body's organs, none more so than the kidneys. Half of patients who suffer kidney damage during surgery die, while others may need lifelong dialysis or kidney transplants. This study is the first ever to use adult stem cell therapy in this way, for this condition, according to Dr. Christof Westenfelder, chief medical officer for AlloCure.

For the study, heart surgeons will inject the stem cells into the aortas of 15 patients at the end of their open-heart surgeries. The patients will be people who are 65 and older or have diabetes, high blood pressure or another risk factor for the kidney damage. Those are the target patients because they are the most likely to get some benefit, although the primary goal of the study is to ensure the treatment is safe, said Dr. John R. Doty, IMC cardiovascular surgeon and lead investigator for the single-center study.

The cells come from the bone marrow of living adult donors and do not have to be matched by blood type to the recipient. They are a special type of stem cell, a kind of rescue-committee cell that moves through the bloodstream unseen by the immune system, stopping when they hear a distress signal from injured organs. They tell the injured organ — in this case, the kidney — how to repair itself. When their job is done, they have a programmed cell death, so there's no residue left in the body after about three days.

"This is a simple, elegant way to deliver the therapy," Doty said, adding that because it's injected in the aorta, it "goes to the kidneys preferentially."

The researchers said there's also potential to treat other injured organs and cells this way. For the trial, the stem cells are being injected in three different doses so that review afterward can help determine optimal dosing, Doty said.

The cells are harvested from donors and prepared at University of Utah's Research Park, using AlloCure's protocol. It's already been used in two patients, with no ill effects at all, Westenfelder said.

So far, the stem cells have proven to be "extraordinarily safe," he said. As part of the study, patients will be followed closely for six months, then more loosely to three years after.

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