Carolinas Medical Center is one of only 50 centers nationwide selected to enroll for the RENEW trial, investigating the efficacy of stem cells for the treatment of chronic myocardial ischemia (CMI). This is an exciting study and one of a few exploring regenerative medicine for the advancement of cardiovascular care. Stem cells have shown promise in several therapeutic areas. We're committed to investigating new therapies and technologies for patients with limited treatment options.
CMI is classified by recurrent angina, chest pain or tightness that can't be controlled with medication or surgical intervention. Patients with chronic angina are often forced to drastically reduce physical exercise to avoid symptoms. A simple walk to the mailbox can become challenging. This is not only frustrating for the patient, but opens the door to a host of risks associated with a sedentary lifestyle. These patients are generally healthy aside from the angina.
The basis of the study involves removing adult autologous CD34+ cells from the patient's blood through apheresis. Electromechanical mapping technology identifies the area of the heart experiencing reduced blood flow thus triggering angina. The CD34+ cells are injected into the problematic part of the heart. The injected cells develop into new blood cells to restore oxygen-rich blood flow.
Patients are randomized into three groups:
- Treatment with the patient's own autologous CD34+ stem cells
- Treatment with placebo
- Unblinded standard of care
After treatment, patients keep a diary to record the occurrence and severity of subsequent angina episodes. It's hoped that this stem-cell therapy will show promise in enhancing blood flow to the heart, decrease chest pain and increase exercise tolerance.
Regenerative medicine using stem cells is an exciting advancement, but not without controversy. The difference between controversial studies and the RENEW study is the source of the stem cells. In this study, stem cells are taken from the patient's own blood instead of a stem-cell bank. Infusing one's own cells back into the body reduces the risk of cell rejection and is generally perceived as a safer method.
Enroll a Patient
For more information about this study, the full list of inclusion and exclusion criteria or to refer a patient, call our Clinical Research department at 704-355-4794.
We're actively recruiting patients for the RENEW study. To be eligible, participants must be:
- between 21 and 80 years of age
- diagnosed with class III or class IV chronic refractory angina
- actively taking the maximum medical therapy for chronic angina without evidence of improved symptoms
Patients who have had a stent or open heart surgery within 60 days of enrolling in the study are excluded.
In This Issue: Fall 2012