First human receives cardiac stem cells to repair damage caused by
15 July 2009
Doctors at the Cedars-Sinai Heart Institute in the US have completed
the first procedure in which a patient's own heart tissue was used to
grow specialized heart stem cells that were then injected back into the
patient's heart in an effort to repair and re-grow healthy muscle in a
heart that had been injured by a heart attack.
The minimally-invasive procedure was completed on the first patient
on Friday, June 26. The procedure is part of a Phase I investigative
study approved by the US Food and Drug Administration and supported by
the Specialized Centers for Cell-based Therapies at the National Heart,
Lung, and Blood Institute and the Donald W. Reynolds Foundation. It is
the first to use adult cells from a patient's own heart to attempt to
heal injured heart muscle.
"This procedure signals a new and exciting era in the understanding
and treatment of heart disease," said Eduardo Marban, MD PhD, director
of the Cedars-Sinai Heart Institute, who developed the technique and is
leading the clinical trial. "Five years ago, we didn't even know the
heart had its own distinct type of stem cells. Now we are exploring how
to harness such stem cells to help patients heal their own damaged
The study is directed by the Cedars-Sinai Heart Institute, with the
collaboration of the Johns Hopkins University, where Dr. Marban worked
prior to joining Cedars-Sinai in 2007. The 24 patients participating in
the study have hearts that were damaged and scarred by heart attacks.
Once enrolled in the study, patients go through a three-step procedure.
After undergoing extensive imaging so doctors can pinpoint the exact
location and severity of the scars wrought by the heart attack, the
patient undergoes a minimally-invasive biopsy, with local anesthesia.
Using a catheter inserted through a vein in the patient's neck, doctors
remove a small piece of heart tissue, about half the size of a raisin.
The heart tissue is then taken to a specialized lab at Cedars-Sinai,
where heart stem cells are cultured using methods invented by Marban and
his team. It takes about four weeks for the cells to multiply to numbers
sufficient for therapeutic use, approximately 10 to 25 million.
In the third and final step, the now-multiplied stem cells are
re-introduced into the patient's coronary arteries during a second
All patients in the study had to have experienced heart attacks
within four weeks prior to enrolling in the research project. Four
patients will receive 12.5 million stem cells and two patients will
serve as controls. Later this summer, it is anticipated that 12 more
patients will undergo procedures to receive 25 million stem cells, while
six additional patients will be monitored as controls.
The first patient, Kenneth Milles, a 39-year-old controller for a
small construction company in the San Fernando Valley, experienced a
heart attack on May 10 due to a 99 percent blockage in the left anterior
descending artery, a major artery of the heart. Milles' heart attack
left 21 percent of his heart muscle infarcted, or scarred. He underwent
his biopsy May 24 and received his infusion of stem cells on June 29.
The patients will be monitored for six months. Complete results are
scheduled to be available in late-2010.
Marban, who holds the Mark Siegel Family Foundation Chair at the
Cedars-Sinai Heart Institute and directs Cedars-Sinai's Board of
Governors Heart Stem Cell Center, also said the cardiac stem cell
procedure is a logical step forward from recent studies in which cardiac
patients have been treated with stem cells derived from bone marrow.
Studies over the past eight years have shown that more than 500 cardiac
patients have experienced modest improvement when treated with bone
marrow stem cells.
However, bone marrow stem cells are not predestined to regenerate
heart muscle. When cardiac stem cells were discovered five years ago by
various teams worldwide, Marban began developing a method for isolating
heart stem cells from minimally-invasive biopsies and then multiplying
the cells. Unlike bone marrow cells, heart stem cells are naturally
programmed to regrow heart tissue, so they could prove more effective in
healing the injury caused by heart attacks.
"If successful, we hope the procedure could be widely available in a
few years and could be more broadly applied to cardiac patients," Marban
said. For example, if patients are able to re-grow damaged heart muscle
via stem cell therapy, there could be lesser demand for expensive and
risky treatments such as heart transplants.
The process to grow the cardiac-derived stem cells involved in the
study was developed by Marban when he was on the faculty of Johns
Hopkins University. The university has filed for a patent on that
intellectual property, and has licensed it to a company in which Dr.
Marban has a financial interest. No funds from that company were used to
support the clinical study. All funding was derived from the National
Institutes of Health, the Donald W. Reynolds Foundation and Cedars-Sinai
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