Cellular therapy of heart failure
According to the results of ixCELL-DCM, the largest clinical study to date devoted to the treatment of heart failure with stem cells, patients with end–stage disease who underwent therapy with stem cells isolated from their own bone marrow suffered 37% fewer cardiac events, including death and hospitalization for heart failure, than patients in the control group.
In total, 126 patients with end-stage heart failure on the background of ischemic disease participated in a double-blind clinical trial conducted under placebo control, who were randomly assigned to the experimental group and the placebo group. A small amount of bone marrow was isolated from the patients, from which two types of cells were isolated and multiplied in the laboratory: mesenchymal stem cells (MSCs) and M2 macrophages. These cells were selected based on the results of preclinical studies indicating their ability to remodel the heart, increase the amount of heart tissue and suppress inflammatory processes.
A drug containing a mixture of cells, called ixmyelocel-T, was injected into the heart tissue of patients using a minimally invasive procedure. Using three-dimensional electrochemical technology, the researchers mapped the damaged areas of the heart, after which the cells were injected directly into these areas using a catheter. On average, the whole procedure lasted less than two hours and in the absence of side effects, the patient was discharged from the clinic the next day.
The examination conducted 1, 3, 6 and 12 months after the procedure showed that the patients who underwent cell therapy developed fewer side effects and complications than the patients in the control group. A year after the procedure, the researchers catalogued all cardiac events, including deaths associated with the underlying disease of hospitalization and unplanned clinic visits.
The results of the analysis of the collected data showed that, compared with the control group, there were fewer deaths in the experimental group (8 and 4, respectively) and fewer hospitalizations for heart failure (42 out of 51 compared to 30 out of 58, or 82.4% compared to 51.7%, respectively). This corresponded to a 37% decrease in the overall frequency of cardiac events.
The duration of the follow-up period was 1 year, and the more delayed effects of therapy are currently unknown. Also, during the study, there were no or only very small statistically significant differences for such indicators of cardiac function as the results of the exercise tolerance test, the left ventricular ejection fraction, the end-diastolic and end-systolic volumes of the left ventricle. However, the researchers believe that such differences can be identified when conducting larger clinical trials.
According to Dr. Amit N. Patel, one of the study's leaders, over the past 15 years, everyone has been talking about the possibilities of cell therapy. The data obtained indicate its real effectiveness. He also notes that in order for ixmyelocel-T to take its place in the list of treatments for terminal heart failure, currently limited to heart transplantation and implantation of a heart pump, it is necessary to conduct phase 3 clinical trials.
The results of the work were presented at the scientific session of the American College of Cardiology held on April 6, 2016.
Article by Amit N Patel et al. Ixmyelocel-T for the Treatment of Patients with Ischemic Heart Failure: A Prospective Randomized Double Blind Trial published in The Lancet
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru Based on University of Utah Health Sciences: Cell Therapy May Mend Damaged Hearts, Study Says.
06.04.2016