Stem cell therapies offer treatment alternatives for peripheral artery disease
Posted May 19, 2010
John Naimi is accustomed to leading a life full of family, farm work and travel. But today, the 55-year-old walnut and almond farmer avoids playing with his nieces and nephews, has scaled back his business and stayed home while his wife traveled to Europe this past summer.
“If I walk too much, my foot becomes stiff. If I get a tiny cut, I know I’m going to have excruciating pain,” says Naimi, who lives in San Jose when he is not at his farm in Gustine, Calif.
Naimi has peripheral artery disease (PAD), a painful condition characterized by reduced blood flow to the limbs that can lead to amputation. He hopes to participate in one of the first clinical trials of a new adult stem cell-based treatment for PAD being pioneered at the UC Davis Institute for Regenerative Cures, a facility supported by the California Institute for Regenerative Medicine.
A place for making stem-cell treatments
In order to test potentially life-saving treatments with human patients, an FDA-approved facility is required for the manufacture of newly developed drugs or cellular therapies using stem cells. UC Davis, with its recently completed Good Manufacturing Practice (GMP) laboratory, is poised to do that testing on its Sacramento campus.
This custom-designed, state-of-the-art facility is the largest academic GMP laboratory in Northern California. Housed within the UC Davis Institute for Regenerative Cures, the 6,000-square-foot suite of scale-up, manufacturing and testing rooms enables stem cell researchers to produce safe and effective clinical-grade therapeutics.
In fact, researchers from institutions around the state are lining up to use it, says Gerhard Bauer, director of the GMP facility.
“We are planning to share its capabilities widely in order to help advance stem cell science and the very real potential for cures,” Bauer says, “because the hallmark of our stem cell work at UC Davis is collaboration.”
Naimi has undergone multiple unsuccessful surgical treatments for PAD. He says that the trial, scheduled to begin in 2010, holds great promise for people like himself who live in fear of losing a limb.
His physician, John Laird, agrees.
“There are still way too many amputations being performed in the U.S. and around the world,” says Laird, director of the UC Davis Vascular Center. “Our ultimate hope is that we can reduce the number.”
In May 2009, researchers from the UC Davis Stem Cell Program published a study in the journal Blood showing that, by using adult human stem cells, they could induce new blood vessels in mice afflicted with reduced blood flow to their limbs. The treatment restored full limb function in the mice.
“We have limited treatment options for patients with severe disease ... Stem cell therapies are especially important for these patients and those who are not candidates for angioplasty, stenting or bypass surgery."
— John Laird, medical director, UC Davis Vascular Center
“We have shown that you can inject adult stem cells into the blood stream that will go directly to the areas of low oxygen and initiate the formation of new blood vessels,” says Jan Nolta, director of the Stem Cell Program and co-lead author on the study. “We like to call these adult stem cells ‘the paramedics of the body’ because they go right to the site of damage and begin repair.”
Laird says that’s potentially good news for Naimi and millions like him who risk amputation due to PAD. “We have limited treatment options for patients with severe disease, and no effective medications to help relieve symptoms or to improve quality of life. Stem cell therapies are especially important for these patients and those who are not candidates for angioplasty, stenting or bypass surgery.”
Naimi is hoping that a new stem cell treatment will result in the regeneration of vessels in his leg.
“For me this is my biggest hope,” he says. “It will mean that I can get my life back on track.”