Cell Therapy Improves Outcomes for Heart Failure Patients, Clinical Trial Finds
A clinical trial conducted at the University of Louisville showed for the first time that treatments for heart failure using cells derived from the patient’s bone marrow and heart resulted in improved quality of life and reduced events major adverse heart attacks in patients after one year.
This is a very important advance in the field of cell therapy and in the management of heart failure. He suggests that one-time treatment may 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. “
Roberto Bolli, MD, director of the Institute of Molecular Cardiology at UofL, responsible for the study at UofL
UofL led the recruitment from seven institutions participating in CONCERT-HF, a phase 2 clinical trial testing the safety, feasibility and efficacy of two types of adult cells, used alone and in combination, in patients with heart failure.
CONCERT-HF evaluated the use of two cell types – autologous mesenchymal stromal cells (MSCs) and c-kit positive heart cells (CPCs) – alone or in combination, in patients with heart failure caused by Chronic ischemic cardiomyopathy, a decrease in heart rate pumping efficiency due to heart attacks and lack of blood reaching the heart. Autologous MSCs are derived from the patient’s bone marrow and CPCs are derived from the patient’s heart tissue. Both are called “autologous” cells because they come from the same patient to whom they are sent for treatment.
In the study, patients treated with CPC cells alone had a significant reduction in major adverse cardiac events, particularly hospitalization. Patients treated with MSC cells alone and with a combination of the two cell types experienced a significantly improved quality of life compared to patients who received no treatment. Quality of life was assessed using patient responses to the Minnesota Living with Heart Failure Questionnaire, which assesses to what extent the physical, emotional and socio-economic effects of heart failure negatively affect the patient’s life and to what extent they prevent him from living as they did. wanted to live.
“The results of this trial show for the first time that cell therapy reduces hospitalizations for heart failure and improves clinical outcomes, providing a compelling rationale for undertaking a pivotal phase 3 trial” which could be the next step on the road to FDA approval, Bolli mentioned.
The results of the CCTRN CONCERT-HF trial were published in the European Journal of Heart Failure. The Phase 2, randomized, placebo-controlled trial, funded by the NIH National Heart, Lung and Blood Institute, was conducted by the Cardiovascular Cell Therapy Research Network (CCTRN), a network of clinical trial researchers involved in the cell therapy for heart disease which includes UofL. UofL led the recruitment into the study, representing 25% of the 125 trial participants.
Bolli’s expertise and long career in successful cardiac research led to the establishment of the CCTRN center at UofL in 2011. This consortium of leading cardiovascular research organizations includes Stanford University, University of of Miami, Indiana University, Texas Heart Institute, University of Florida and the Minneapolis Heart Institute Foundation in addition to UofL. The School of Public Health at the University of Texas at Houston Health Sciences Center serves as the data coordination center.
Bolli is a pioneer in research using adult stem cells for heart disease. Over the past two decades, he has shown that CPCs are beneficial in many preclinical models of heart failure, paving the way for the CONCERT-HF trial. He also led the recent CCTRN SENECA trial – the first study to demonstrate the safety and potential effectiveness of cell therapy in cancer survivors with heart failure caused by cancer therapy.
Bolli, R., et al. (2021) A phase II study of autologous mesenchymal stromal cells and c-kit positive heart cells, alone or in combination, in patients with ischemic heart failure: the CCTRN CONCERT-HF trial. European Journal of Heart Failure. doi.org/10.1002/ejhf.2178.