Mayo Clinic has announced the development of a new catheter to place a person's own stem cells into the beating heart.
"The novel device includes a curved needle and graded openings along the needle shaft, allowing for increased distribution of cells," Mayo said in an announcement. "The result is maximized retention of stem cells to repair the heart."
The next seminal step would be demonstrating that cells taken from a person's own body, then coaxed to become stem cells and implanted in the heart, actually heal the heart tissue.
The work was a collaboration betweenthe Mayo Clinic Center for Regenerative Medicine in Rochester and Cardio3 Biosciences in Mont-Saint-Guibert, Belgium.
Cardio3 has a presence in Rochester and has been collaborating with Mayo scientists for several years, working toward the development of ways to heal the human heart using a person's own stem cells.
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"Although biotherapies are increasingly more sophisticated, the tools for delivering regenerative therapies demonstrate a limited capacity in achieving high cell retention in the heart," said Mayo cardiology specialist Dr. Atta Behfar, lead study author of the study. "Retention of cells is, of course, crucial to an effective, practical therapy."
A study highlighting the newly developed catheter appears in the scientific journal " Circulation: Cardiovascular Interventions ."
Computer modeling was done in Belgium, and the device models were tested in North America for safety and retention efficiency.
Curving the catheter eliminates backflow and limits loss of cells, Mayo said. In addition, graded small-to-large side holes limit pressures in the heart to keep cells targeted."
The catheter is being used in European CHART-1 clinical trials for repair of damaged hearts.
Those trials are the first Phase III trial "to regenerate hearts of patients who have suffered heart-attack damage."
Mayo Clinic cardiology specialist Dr. Andre Terzic, one of the study's co-authors, reached after hours Monday night, said if the Phase III trials are successful, "regenerative medicine is poised to offer new options for renewed heart health."
Mayo and Cardio3 appear to be positioning themselves to offer the procedure if the Phase III trial is successful in Europe. If that happens, the regulatory process in the United States would be easier.
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The Mayo Clinic Care Network that is rapidly spreading across the U.S., with member health centers maintaining their own ownership, could conceivably make the procedure rapidly available nationally, once regulatory hurdles are passed.
"A transformative outcome for patients with advanced heart failure would be reducing the need for donor hearts and transplantation," Terzic said. "To accelerate such benefit for patients, a new tool for maximized placement of reparative stem cells into the beating heart has now been developed — achieving a seminal step."
Health reporter Jeff Hansel writes the Pulse on Health column every Monday. Follow him on Twitter @JeffHansel.
