Phoenix Arizona News - Arizona Local News
Valley doctor uses stem cells to repair heart scar tissues
Testing continues for new procedure
Luci Scott
The Arizona Republic
Nov. 29, 2007 12:00 AM
The director of cardiovascular research at Chandler Regional and Mercy Gilbert medical centers recently appeared at a meeting of the American Heart Association in Orlando to report on his promising work in replacing scar tissue caused by heart attacks.
Dr. Nabil Dib spoke about patients who participated in Phase 1 clinical trials in which he used a catheter to deliver stem cells to damaged muscle, restoring heart function.
Phase 2 clinical trials, approved by the U.S. Food and Drug Administration, would involve 165 patients, and Dib is waiting for hospital approval.
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"It's going to be a double-blind, randomized trial to assess efficacy and quality of life of the patients, survival of patients and their heart function," Dib said.
The procedure involves transplanting cells taken from the thigh muscle of the patient.
Here's how Dib's procedure works: A sample of the patient's thigh muscle is sent to Mytogen Corp. in Boston, a subsidiary of Advanced Cell Technology. At Mytogen, scientists isolate the stem cells from the adult cells and grow more stem cells in the lab. Every gram of muscle has about 5,000 stem cells. In four weeks, the number of cells grows to 500 million.
This is important because a patient who has a moderate to severe heart attack usually loses about 500 million cells, Dib said.
Stem cells could be surgically transplanted into the heart, but most patients with heart failure are so sick they cannot tolerate general anesthesia.
Dib transplants the cells via a catheter, using a minimally invasive procedure that targets the scar tissue. He uses a local anesthetic. He inserts the catheter into the heart by first going into an artery in the groin, similar to angioplasty.
"It's done while the patient is awake and it lasts 2 to 2? hours. He does not feel pain during the injection," Dib said. "Six hours later, he'll be walking, and the next day he'll be home."
This year, Dr. William O'Neill, executive dean of clinical affairs at the Miller School of Medicine at the University of Miami in Florida, called Dib's Phase 1 research "a very big leap forward."
"It was a very important feasibility trial," O'Neill said. "It's not a definitive study, but it really answered a lot of important questions about what needed to be done to start a larger, multicenter trial to prove definitively that the treatment works."
The first phase of Dib's study was done on 23 patients, all in Arizona. Eleven were in a control group that did not receive the stem cells, and 12 received the cells. The data were analyzed blindly in the world-renowned Cleveland Clinic.
The patients in the control group grew worse while those injected with stem cells improved.
No embryonic stem cells, the type that have generated national controversy, are used in his research.
Dib said that if his research continues to show positive results, lives could be saved.
"And definitely there's an improvement in the quality of life," he said.
O'Neill said other researchers tried the same technique in Europe but had problems with irregular and abnormal heartbeats.
Dib said the main difference in results between the European work and his can be attributed mainly to the process of cell formulation by Mytogen and, secondly, Dib uses three-dimensional technology so he does not inject the same area of the heart a second time.
"We need to give credit to Mytogen," he said.
Heart patients interested in participating in Dib's research can learn more at www.cardiostem.com or call 1-800-959-3807.
Valley doctor uses stem cells to repair heart scar tissues
Testing continues for new procedure
Luci Scott
The Arizona Republic
Nov. 29, 2007 12:00 AM
The director of cardiovascular research at Chandler Regional and Mercy Gilbert medical centers recently appeared at a meeting of the American Heart Association in Orlando to report on his promising work in replacing scar tissue caused by heart attacks.
Dr. Nabil Dib spoke about patients who participated in Phase 1 clinical trials in which he used a catheter to deliver stem cells to damaged muscle, restoring heart function.
Phase 2 clinical trials, approved by the U.S. Food and Drug Administration, would involve 165 patients, and Dib is waiting for hospital approval.
advertisement
"It's going to be a double-blind, randomized trial to assess efficacy and quality of life of the patients, survival of patients and their heart function," Dib said.
The procedure involves transplanting cells taken from the thigh muscle of the patient.
Here's how Dib's procedure works: A sample of the patient's thigh muscle is sent to Mytogen Corp. in Boston, a subsidiary of Advanced Cell Technology. At Mytogen, scientists isolate the stem cells from the adult cells and grow more stem cells in the lab. Every gram of muscle has about 5,000 stem cells. In four weeks, the number of cells grows to 500 million.
This is important because a patient who has a moderate to severe heart attack usually loses about 500 million cells, Dib said.
Stem cells could be surgically transplanted into the heart, but most patients with heart failure are so sick they cannot tolerate general anesthesia.
Dib transplants the cells via a catheter, using a minimally invasive procedure that targets the scar tissue. He uses a local anesthetic. He inserts the catheter into the heart by first going into an artery in the groin, similar to angioplasty.
"It's done while the patient is awake and it lasts 2 to 2? hours. He does not feel pain during the injection," Dib said. "Six hours later, he'll be walking, and the next day he'll be home."
This year, Dr. William O'Neill, executive dean of clinical affairs at the Miller School of Medicine at the University of Miami in Florida, called Dib's Phase 1 research "a very big leap forward."
"It was a very important feasibility trial," O'Neill said. "It's not a definitive study, but it really answered a lot of important questions about what needed to be done to start a larger, multicenter trial to prove definitively that the treatment works."
The first phase of Dib's study was done on 23 patients, all in Arizona. Eleven were in a control group that did not receive the stem cells, and 12 received the cells. The data were analyzed blindly in the world-renowned Cleveland Clinic.
The patients in the control group grew worse while those injected with stem cells improved.
No embryonic stem cells, the type that have generated national controversy, are used in his research.
Dib said that if his research continues to show positive results, lives could be saved.
"And definitely there's an improvement in the quality of life," he said.
O'Neill said other researchers tried the same technique in Europe but had problems with irregular and abnormal heartbeats.
Dib said the main difference in results between the European work and his can be attributed mainly to the process of cell formulation by Mytogen and, secondly, Dib uses three-dimensional technology so he does not inject the same area of the heart a second time.
"We need to give credit to Mytogen," he said.
Heart patients interested in participating in Dib's research can learn more at www.cardiostem.com or call 1-800-959-3807.
