“Patients in the (Dream-HF) trial were on full...

“Patients in the (Dream-HF) trial were on full guideline-recommended drug therapy for heart failure, suggesting that the effect of the cell therapy was synergistic with and additive to state-of-the-art heart failure medications.MPC-treated patients showed significant strengthening of the left ventricular muscle within the first 12-months as measured by an increase in left ventricular ejection fraction, which measures the heart’s pumping ability and is one of the metrics used to assess overall heart function. Over a mean follow-up of 30-months, treatment with MPCs reduced the risk of cardiovascular death, heart attack, or stroke, with a greater decrease in patients with increased inflammation. MPC treatment reduced the rate of heart attack or stroke by 58%, and the benefit rose to 75% in patients who had high levels of a blood marker for inflammation. Similarly to what was seen with these major adverse cardiovascular events, improvement in ejection fraction was even more pronounced in patients with higher inflammation levels. MPC therapy did not further reduce recurrent heart failure events requiring hospitalization over and above the effects of traditional drugs which reduce circulating volume overload caused by the maladaptive effects of neurohormonal activation. This aspect of heart failure treatment is already addressed by the currently available medications.

“The results of DREAM-HF are an important step in understanding how cell therapy provides benefits in patients with chronic heart failure due to poor pump function. The cells appear to work by reducing inflammation, increasing microvascular flow, and strengthening heart muscle. Locally, in the heart, the MPCs can protect cardiac muscle cells from dying and can improve blood flow and energetics. In large blood vessels throughout the body, the reduced inflammation resulting from the activation of MPCs may decrease plaque instability, which is what leads to heart attacks and strokes. The cells seem to have a systemic immune modulatory and anti-inflammatory effect,” according to the study’s lead author, Dr. Emerson C. Perin, MD, PhD, FACC, Medical Director at The Texas Heart Institute.

The DREAM-HF findings of long-term improvements in outcomes for patients with chronic heart failure due to low ejection fraction and poor pump function are an important milestone in the field of cell therapy for cardiovascular disease. The results help in identifying those heart failure patients with inflammation who are at greatest risk and most likely to benefit from MPC therapy and findings will be confirmed in future studies. This seminal trial sets the stage for eventually adding cell therapy to the treatment arsenal for heart failure.”

https://www.eurekalert.org/news-releases/980887

The other trial that was discussed at the recent Type B meeting is the above, on the use of Revascor in advanced, Stage 2/3 (pre- end stage) patients. I wonder if Dream-HF trial could be considered as the confirmatory trial for the HF LVAD trial? The patients are slightly less advanced in disease condition but the MoA is the same and the patients in both studies have reduced refraction.

It’s not pie in the sky. It’s a completed trial with published results, based on 565 patients recruited in over 50 sites. The pre-BLA meeting the LVAD will be extremely important and interesting to watch. Can’t wait for that and the meeting on children’s HLHS to happen, with the latter expected to be next quarter. The latter may provide much needed cash on approval, given the excellent results and its rare paediatric disease and orphan drug designations (RPDD and ODD).