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Cell therapy reduces cardiac events in certain patients with HFrEF
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CHICAGO — In the phase 2b ixCELL-DCM trial, patients with HF with reduced ejection fraction due to ischemic dilated cardiomyopathy who received catheter-based transendocardial injection of ixmyelocel-T cell therapy had reduced cardiac events compared with those who received placebo.
Researchers conducted the randomized, double blind, placebo controlled trial of 126 patients with HF with reduced EF (HFrEF) due to ischemic dilated cardiomyopathy with left ventricular EF 35%, an implantable cardioverter defibrillator and ineligibility for revascularization.
Patients were assigned ixmyelocel-T (Vericel) or placebo, and received therapy at the time of bone marrow aspiration. Ixmyelocel-T is a mixed-cell therapy with a similar mixture of cell types as those found in the bone marrow mononuclear cell population, 200 times more M2 macrophages and 50 times more CD90+ mesenchymal stem cells, according to the researchers. It is thought to have greater biological activity than single-cell therapy.
The primary composite endpoint was all-cause mortality, CV hospital admission or unplanned clinic visit for treatment of acute compensated HF. Follow-up was 12 months.
The intention-to-treat population included 114 patients and the per-protocol population included 109 patients.
Timothy D. Henry, MD, interventional cardiologist and director of cardiology at Cedars-Sinai Medical Center, said during a press conference that according to the per-protocol primary efficacy analysis, assignment to cell therapy was associated with a 37% reduction in the primary endpoint (RR = 0.63; 95% CI, 0.42-0.97). He said the researchers determined event rates of 109.97 per 100 patient-years for the placebo group and 69.76 per 100 patient-years for the cell therapy group in the per-protocol analysis.
Timothy D. Henry
In the primary safety analysis of the per-protocol population, 75% of the placebo group had serious adverse events compared with 53% of the cell-therapy group (P = .0197), Henry said.
Henry added that “there was no improvement in the secondary endpoints of [LVEF] or [LV] volume, [NYHA] class or 6-minute walk.” – by Erik Swain
Reference s :
Henry TD. Late-Breaking Clinical Trials V. Presented at: American College of Cardiology Scientific Session; April 2-4, 2016; Chicago.
Patel AN, et al. Lancet. 2016;doi:10.1016/S0140-6736(16)30137-4.
Disclosure: The study was funded by Vericel. Henry and four other researchers report receiving grants and personal fees from Vericel. Three other researchers report being employed by Vericel at the time of the study.
Perspective
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Sanjeev Gulati, MD, FACC
This study adds to existing data showing that cell therapy is a viable option in patients with advanced HF, and that it can be done less invasively than surgery, which is critically important for those patients. We now have potential for another therapy to reduce death and hospitalizations, which have been a major focus of contemporary HF trials.
The results suggest that we should move to a larger clinical trial to prove the findings of this therapy. This is an important step in helping patients with HF. One day, I can imagine using cell therapy earlier than just in the advanced HF stage, particularly in patients with ischemic cardiomyopathy. For example, when a patient has an MI, we would love to perform an intervention earlier in their course. Eventually, we might be able to consider a stem cell therapy even in the midst of their hospitalization for the MI. We’re not there yet, but I think that’s where we need to go to truly help reduce the progression of HF.
We should also think about these findings in the context of prevention. The best way to prevent the need for HF therapy is to never get HF in the first place. If people can be more active, watch their BP, diabetes and cholesterol, they can control their risk factors before ever even getting the disease.Click Here to Manage Email Alerts