US Stem Cell Inc (OTCMKTS:USRM)
US Stem Cell Inc (OTCMKTS:USRM) is a biotechnology company that was formerly known as Bioheart, Inc. US Stem Cell, headquartered in Sunrise, FL, seeks to discover, develop, and commercialize autologous cell therapies for the treatment of chronic and acute heart damage. The company’s current drug candidates include MyoCell, MyoCell SDF-1, and AdipoCell. On April 13, 2017 US Stem Cell Inc (OTCMKTS:USRM) announced that it had received a commitment to invest up to $5,000,000 from private equity firm General American Capital Partners LLC (GACP) in exchange for up to 63,873,275 shares of common stock.
MyoCell is being developed by US Stem Cell Inc (OTCMKTS:USRM) as a treatment to improve cardiac function months or years after a patient has experienced heart damage due to a heart attack. The treatment involves the removal of a small amount of muscle from the patient’s thigh. Muscle stem cells, called myoblasts, are isolated and expanded utilizing a proprietary cell-culturing process. These cells are then injected directly into the heart’s scar tissue through an endoventricular needle-injection catheter by a surgeon. The stem cells then populate the area of scar tissue to, hopefully, improve cardiac function. The peer-reviewed American Heart Journal published the results of clinical trial Marvel-1. According to the article, when compared with a placebo, myoblast therapy was associated with sustained (six months) improvements in six-minute walk distance of >90 meters, a clinically meaningful improvement.
US Stem Cell Inc (OTCMKTS:USRM) is also developing MyoCell SDF-1. This treatment has recently received approval from the U.S Food and Drug Administration (FDA) to begin human clinical trials. MyoCell SDF-1 is being developed as an improvement to the MyoCell treatment. In preclinical studies, MyoCell SDF-1 provided a 54% improvement of heart function compared to 27% for the original MyoCell composition, while the placebo control treated animals declined by 10%. The preclinical studies also demonstrated that this product candidate can enhance blood vessel formation in damaged hearts.
Lastly, US Stem Cell Inc (OTCMKTS:USRM) is also developing its AdipoCell treatment. Adipose (fat) tissue is readily available and has been shown to be rich in microvascular, myogenic and angiogenic cells. In collaboration with the Regenerative Medicine Institute in Tijuana, Mexico, congestive heart failure patients are being treated in a Phase I/II trial at Hospital Angeles Tijuana. Reportedly, these patients have demonstrated, on average, an absolute improvement of 13% in ejection fraction and an increase of 100 meters in their six-minute walk distance. US Stem Cell Inc (OTCMKTS:USRM) has recently applied to the FDA to begin trials using adipose derived stem cells or AdipoCell™ in patients with chronic ischemic cardiomyopathy. The therapy involves the use of stem cells derived from the patient’s own fat (adipose tissue) obtained using liposuction. Transplantation of AdipoCell™ is accomplished through endocardial implantations with an injection catheter.
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About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading.