U.S. Stem Cell, Inc. (USRM) products

U.S. Stem Cell’s lead product candidate is MyoCell®, a muscle stem cell therapy that is intended to improve cardiac function months or even years after a patient has suffered severe heart damage due to a heart attack. The procedure involves a physician removing a small amount of muscle from the patient’s thigh. From this muscle specimen, muscle stem cells (also called myoblasts) are then isolated, expanded using U.S. Stem Cell’s proprietary cell-culturing process, and injected directly into the scar tissue of the patient’s heart.

MyoCell SDF-1 has received approval from the FDA to begin human clinical trials and is intended to be an improvement to MyoCell. The myoblast cells to be injected are gene-modified prior to injection by an adenovirus vector so that they will release extra quantities of stromal derived factor – 1 or SDF-1 protein. Following injury which results in inadequate blood flow to the heart, such as a heart attack, the human body naturally increases the level of SDF-1 protein in the heart.

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. These patients have demonstrated on average an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their six minute walk distance.