Temple Hospital launches stem cell trial for heart failure patients
Tribune Staff Report | Posted Yesterday
Temple University Hospital has launched a new stem cell trial for patients with end stage heart failure.
The hospital is participating in a nationwide, Phase-2 stem cell clinical trial aimed at improving quality of life for patients with end stage heart failure due to ischemic dilated cardiomyopathy (IDCM).
In patients with IDCM, the heart has a decreased ability to pump blood because the left ventricle — which is the main pumping chamber — is enlarged, dilated and weak. This is caused by ischemia, which is a lack of blood supply to the heart muscle caused by coronary artery disease and/or heart attacks.
Heart failure caused by IDCM can lead to frequent hospital admissions and unplanned outpatient and emergency department visits. It also often causes patients to suffer a variety of symptoms, including but not limited to shortness of breath, swelling of the legs and feet, fatigue, chest pain, palpitations and fainting.
The randomized trial — called ixCELL DCM — is investigating whether a patient’s own stem cells can improve blood flow in damaged areas of the heart by creating new blood vessels. The trial is for heart failure patients with IDCM who are not candidates for a heart transplant, either because they are not yet sick enough or because they are too sick.
“This is an important trial and we are pleased to be able to offer it to our patients, because it provides a new option for patients who otherwise have exhausted all of their current options for treatment,” said Dr. Jon M. George, the local principal investigator and an adjunct professor at the Cardiovascular Research Center at Temple’s School of Medicine.
Patients who meet the clinical criteria for participation will have stem cells removed from their own bone marrow. Those stem cells will be sent to a lab where they will be enhanced and expanded before being returned to Temple about two weeks later to be injected into the patient’s heart tissue.
Doctors use a special mapping tool, called NOGA, to view and identify the exact areas of the heart which have been damaged. They then inject the stem cells directly into the border zones surrounding those areas because those zones have been shown to best support the creation of new blood vessels and the repair of damaged vessels.
Patients not randomized to receive stem cell treatment are given a placebo. All patients in the trial will undergo 12 months of monitoring and follow-up visits, which will include — among other things — walk tests, echocardiograms, quality of life measurements and documentation of hospital admissions and unplanned outpatient and emergency department visits due to heart failure.
Temple researchers will be analyzing whether patients in the group who receive the stem cell treatment experience improved heart function; lower mortality; a reduction in symptoms; and a lower number of hospitalizations, and unplanned outpatient visits and emergency department visits due to their heart failure compared to patients who receive the placebo.
The trial is sponsored by Vericel Corporation, which processes the stem cells used in the research.
Temple has enrolled two patients and is currently pre-screening other patients for the trial. For more information call Jennie Wong, registered nurse and clinical research coordinator at (215) 707-5340.
Tribune Staff Report | Posted Yesterday
Temple University Hospital has launched a new stem cell trial for patients with end stage heart failure.
The hospital is participating in a nationwide, Phase-2 stem cell clinical trial aimed at improving quality of life for patients with end stage heart failure due to ischemic dilated cardiomyopathy (IDCM).
In patients with IDCM, the heart has a decreased ability to pump blood because the left ventricle — which is the main pumping chamber — is enlarged, dilated and weak. This is caused by ischemia, which is a lack of blood supply to the heart muscle caused by coronary artery disease and/or heart attacks.
Heart failure caused by IDCM can lead to frequent hospital admissions and unplanned outpatient and emergency department visits. It also often causes patients to suffer a variety of symptoms, including but not limited to shortness of breath, swelling of the legs and feet, fatigue, chest pain, palpitations and fainting.
The randomized trial — called ixCELL DCM — is investigating whether a patient’s own stem cells can improve blood flow in damaged areas of the heart by creating new blood vessels. The trial is for heart failure patients with IDCM who are not candidates for a heart transplant, either because they are not yet sick enough or because they are too sick.
“This is an important trial and we are pleased to be able to offer it to our patients, because it provides a new option for patients who otherwise have exhausted all of their current options for treatment,” said Dr. Jon M. George, the local principal investigator and an adjunct professor at the Cardiovascular Research Center at Temple’s School of Medicine.
Patients who meet the clinical criteria for participation will have stem cells removed from their own bone marrow. Those stem cells will be sent to a lab where they will be enhanced and expanded before being returned to Temple about two weeks later to be injected into the patient’s heart tissue.
Doctors use a special mapping tool, called NOGA, to view and identify the exact areas of the heart which have been damaged. They then inject the stem cells directly into the border zones surrounding those areas because those zones have been shown to best support the creation of new blood vessels and the repair of damaged vessels.
Patients not randomized to receive stem cell treatment are given a placebo. All patients in the trial will undergo 12 months of monitoring and follow-up visits, which will include — among other things — walk tests, echocardiograms, quality of life measurements and documentation of hospital admissions and unplanned outpatient and emergency department visits due to heart failure.
Temple researchers will be analyzing whether patients in the group who receive the stem cell treatment experience improved heart function; lower mortality; a reduction in symptoms; and a lower number of hospitalizations, and unplanned outpatient visits and emergency department visits due to their heart failure compared to patients who receive the placebo.
The trial is sponsored by Vericel Corporation, which processes the stem cells used in the research.
Temple has enrolled two patients and is currently pre-screening other patients for the trial. For more information call Jennie Wong, registered nurse and clinical research coordinator at (215) 707-5340.