Skeletal Myoblasts Transplanted Into Cardiac Muscle for First Time in U.S.
NEW YORK (Reuters Health) – Physicians at the Mount Sinai Medical Center in New York have implanted autologous skeletal myoblasts into the heart of a patient with congestive heart failure.
The procedure–a first for the U.S.–was performed on April 15th in a 44-year-old male, as part of a phase I multicenter study to confirm the safety and feasibility of the technique.
Dr. Warren Sherman, who is co-principal investigator along with his Mount Sinai colleague Dr. Valentin Fuster, told Reuters Health that the patient had a history of previous myocardial infarction, with congestive heart failure between classes II and III on the New York Heart Association scale. The patient, he said, “was not sick enough to be a transplant candidate, not bedbound…He was able to get about, but at a reduced level.”
In the procedure, “we took a piece of thigh muscle about the size of his little finger,” Dr. Sherman said. “That muscle was processed to isolate the skeletal myoblasts that serve to replace skeletal muscle when it’s damaged.”
He added, “Heart muscle does not have an abundance of these cells…and they are not nearly as effective. The heart is incapable of regeneration.”
The cells were grown in culture for 3 weeks. Then, Dr. Sherman said, “We used a catheter, in much the same way as you use it for traditional cardiac catheterization, and we injected the cells directly into the area of a previous heart attack….After a series of injections, the catheter is withdrawn.”
The patient will remain hospitalized for several days, and will be followed closely for a year. “This study is about safety,” Dr. Sherman said. “We want to make sure he isn’t harmed by this. We want to see how his heart functions, and detect any abnormalities the cells may impose on the heart.”
The procedure has already been performed at several centers in Europe. “There have been no side effects in any patients in Europe,” or in any preliminary animal studies, Dr. Sherman said.
The American trial will eventually enroll 15 patients at four centers: Mount Sinai, Abbott Northwest Medical Center in Minneapolis, Minnesota, the Cleveland Clinic, and the Mayo Clinic.
Dr. Sherman pointed out some of the technique’s advantages: the cells are implanted without surgery, there’s no risk of rejection, and the ethical issues of stem cell transplants are avoided.
Dr. Sherman expects that it will take approximately 8 months to enroll all the patients in the phase I trial. Each will then be followed for a year after the procedure. In addition, he and his colleagues are in the early stages of planning an efficacy study. “We’re all quite excited and intrigued by the possibilities,” he said, “but we have a long way to go.”
