This article was written in collaboration with Dr. Emerson Perin, Director of the Center for Clinical Research, Texas Heart Institute, Houston, TX.
Heart failure with reduced ejection fraction is a chronic but progressive disease. Patients can live several years and even decades with chronic systolic heart failure. However, the progression of the disease can lead to decompensation and hospitalization. This can affect the prognosis of the patient and increase the risk of mortality by 20% within the first year and 50% within five years. This is despite optimal guideline-directed medical therapy such as beta-blockers (metoprolol or carvedilol), angiotensin receptor and neprilysin inhibitors ( Entresto), mineralocorticoids (spironolactone), and sodium-glucose cotransporter-2 inhibitors (Jardiance, Farxiga). These treatments affect primarily the neurohormonal abnormalities seen in decompensated heart failure. Inflammation and vascular abnormalities also play a role but its treatment has been elusive.
What Kind of Stem Cells Can Be Used for the Treatment of Heart Failure?
Stem cells are the key to the next generation of medicine and are being studied for tissue and organ repair, cancer treatment, gene therapy, bioengineering, pharmaceutical development, personalized medicine, and anti-aging. Stem cells have the properties of replicating themself or generating a daughter cell similar to the parent cell as well as differentiating into different tissue types. Embryonic stem cells are pluripotent and can differentiate into any tissue. Adult stem cells are considered multipotent: Hematopoietic stem cells can renew themselves and can produce new blood cells. Mesenchymal cells are adult, multipotent cells that can be found in many tissues like the bone marrow, adipose tissue, the lungs, and the heart and blood vessels.
Bone marrow-derived human mesenchymal stem cells are a viable source of allo-cells because they lack major histocompatibility effects rendering them immuno-evasive. Studies have shown that the most significant aspect of these stem cells is their capability to secrete various hormone-like substances and growth factors, so-called paracrine effects. They chemically act on areas such as the myocardium and the endothelial cells or inner lining of the blood vessels.
What is the Effect of Stem Cells in the Treatment of Heart Failure?
Despite early preclinical studies showing promising results of cardiac regeneration and reduction in scar tissue, no phase 3 clinical studies in humans have shown any benefits in survival or hospitalization for heart failure.
The DREAM-HF used mesenchymal allogeneic cells obtained from the bone marrow of young and healthy donors and injected these cells into the heart muscle of patients with heart failure, with or without coronary artery disease. Of interest, the stem cells decreased the risk of non-fatal myocardial infarction and stroke by 65%. In less advanced heart failure patients (New York Heart class 2), stem cells given in addition to maximal guideline-directed medical therapy not only reduced non-fatal MI or stroke but reduced cardiac mortality. These effects were most marked in patients with more systemic inflammation as measured as baseline plasma hs-CRP levels.
Will There Be a Role for Stem Cells in the Treatment of Heart Failure?
There is still considerable skepticism in the clinical community about the role of stem cells in the treatment of heart failure. Stem cell therapy is safe, and studies like DREAM-HF advance our understanding of the contribution of inflammation and vascular abnormalities in heart failure. The recognition of paracrine effects represents a big step, and, in the future, we may explore the role of exosomes as paracrine mediators. Isolating their protective constituents could be important in bringing pharmacological research and development.
Despite the lack of evidence, there are over 500 businesses in the US offering stem cell therapy, including over 60 for heart failure. If you are a patient with heart failure and you want to try stem cell therapy, ask your doctor if there are studies that would be a good fit for you. If you participate in a legitimate clinical trial, you should not have to pay for your treatment or the follow-up related to that research. You may be assigned to placebo and may not receive the stem cells, but chances are that you will benefit from the strict application of guideline-guided medical therapy and have rigorous follow-ups and appropriate testing.
This article was written in collaboration with Dr. Emerson Perin, Director of the Center for Clinical Research, Texas Heart Institute, Houston, TX.
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