This article is more than 5 years old. Information may no longer be current.
CAUSMIC: Autologous skeletal myoblasts improved NYHA class, quality of life
Small trial yields promising results about the potential for stem cells in thwarting heart failure in patients with prior MI.
Click Here to Manage Email Alerts
Patients with prior myocardial infarction and symptoms of congestive heart failure treated with myoblasts demonstrated one-year outcomes better than patients who received maximal medical therapy.
After therapy, patients improved by one NYHA class and fared better on the Minnesota Living with Heart Failure Score, according to Nabil Dib, MD, director of clinical cardiovascular cell therapy and associate professor of medicine at University of California, San Diego.
Dib, also director of cardiovascular research at Mercy Gilbert Medical Center in Phoenix, said that the findings are extremely important.
The researchers assigned patients to receive a 3D-guided catheter-based injection of myoblasts in escalating doses from 30 million to 600 million cells to the endocardium (n=12) or maximal medical therapy (n=11). Patients had prior MI and symptoms of congestive HF: ejection fraction <40% and NYHA Class II to IV.
The researchers harvested cells from patient’s thigh muscles. After being grown to multiply the cell numbers, the cells were injected into the patients via an investigational catheter using a 3D voltage mapping system.
While patients who received maximal medical therapy worsened on each measure, the results demonstrated favorable outcomes among patients who received all doses of cells, including the highest dose of 600 million cells. They generally had improved pumping function and in a blinded echocardiographic assessment done by Cleveland Clinic, researchers found that the heart dimension decreased in the myoblast group and increased in the control group.
“This is an extremely important finding. Why?” Dib asked. “Because if that’s reproducible in a larger trial, then we can deliver the cell early after a heart attack and prevent the deterioration to heart failure. That’s what that means. That’s how huge the impact is going to be on medicine and hospitalization.”
At 12 months, there was no significant difference between groups with occurrence of arrhythmia; there was one instance in each group that was treated with implantable cardioverter defibrillators. All patients survived with no complications relating to the procedure.
The FDA cleared a phase-2 trial to continue this research and researchers plan to study 165 patients in a multicenter clinical design, Dib said. – by Judith Rusk
For more information:
- Dib N. Final one-year results of the CAUSMIC Trial: First United States randomized controlled trial utilizing 3D guided, catheter-based delivery of autologous skeletal myoblasts for ischemic cardiomyopathy. DS.25. Presented at: American Heart Association 30th Annual Scientific Sessions; Nov. 4-7; Orlando.