Numerous forms of cell therapy have been proposed and tested for the treatment of heart failure over the years, from the earliest stem cell therapies to the broader variety of cell types and increasing technical sophistication attempted today. The results here seem promising. Much of the challenge of early efforts was the lack of reliability in outcomes. While first generation stem cell therapies fairly reliably reduce inflammation, they have not delivered on the promise of regeneration. Clinical trials are overly costly in the present system of regulation, and could be run at far less expense absent the regulators, but something like passing a clinical trial with a hundred or more patients is an important milestone to demonstrate reliability. The effect size demonstrated here is modest - a ~20% reduction in cardiac events, with none of the desired structural changes in the heart in evidence - but that is a starting point.
A clinical trial has shown for the first time that heart failure treatments using cells derived from the patient's own bone marrow and heart resulted in improved quality of life and reduced major adverse cardiac events for patients after one year. "This is a very important advance in the field of cell therapy and in the management of heart failure. It suggests that a treatment, given only once, can produce long-term beneficial effects on the quality of life and prognosis of these patients. The results pave the way for a larger, Phase 3 trial of cell therapy in heart failure."
CONCERT-HF evaluated the use of two types of cells - autologous mesenchymal stromal cells (MSCs) and c-kit positive cardiac cells (CPCs) - alone or in combination, in patients with heart failure caused by chronic ischemic cardiomyopathy, a decrease in heart pumping effectiveness due to heart attacks and a lack of blood getting to the heart. Autologous MSCs are derived from the patient's bone marrow and CPCs are from the patient's heart tissue. Both are known as "autologous" cells because they come from the same patient in whom they are returned for the treatment.
In the study, patients treated with CPC cells alone had a significant 22% reduction in major adverse cardiac events, particularly hospitalization. Patients treated with MSC cells alone and with a combination of both types of cells experienced significantly improved quality of life compared with patients who received no treatment. Left ventricular ejection fraction, left ventricular volumes, scar size, 6-min walking distance, and peak oxygen consumption did not differ significantly among groups.