How Our Approach Performs
In contemporary times, riding on the coat-tails of stem cell’s success in treating Leukemia & Lymphoma, widespread use of autologous stem-cell transplantation to treat metastatic breast cancer, has ultimately shown to be ineffective.
Stem cell therapy is a promising treatment strategy for patients with heart failure, which accounts for over 10% of deaths in the U.S. annually. However, published data from small, uncontrolled trials and a few well-controlled, randomized trials in stem cells for heart failure and graft-versus-host disease have failed to demonstrate consistent effectiveness of stem-cell treatments.1,2 https:// www.nejm./doi/full/10.1056/NEJMp1613723#
In spite of increasing reports of stem cell benefits to injured knee cartilage or a neurologic deficits —is still a challenge to scientifically document and reproduce.
Over the last decade, investigators have proposed three basic mechanisms to support the assertion that stem cell therapy can be used as an effective treatment for HF:
• once believed that adult stem cells could generate new cardiac tissue,7,8 further investigation has revealed that few if any adult stem cells differentiate into cardiomyocytes and engraft into the myocardium.9
• stem cells could generate vasculature via angiogenesis or vasculogenesis by activating endogenous endothelial progenitor cells (EPCs) or recruiting them from the vasculature. The existence of EPCs, however, remains controversial due to a lack of unique surface markers to identify these cells.10
• mounting evidence now suggests that adult stem cells may exert paracrine effects by secreting cardio-protective factors. These secreted factors may stimulate vascular growth and remodeling, attenuate fibrosis, modulate inflammation, regulate cell differentiation and survival, and recruit resident stem or progenitor cells.12,13
• recent studies have shown that these factors may be clustered into extracellular membrane vesicles, including exosomes and microsomes, which can then transfer proteins, lipids, RNA, and microRNAs to mediate cardioprotection.14,15
Delivering these vesicles of regenerative growth factors, in addition to stem cells themselves, is a clinically attractive therapeutic option from a regulatory and commercial perspective.
This is the science we base our choice of regenerative agent upon