Sunrise, FL – October 11, 2017 – (OTC:USRM) U.S. Stem Cell, Inc., a Florida corporation and leader in novel regenerative medicine solutions and physician-based stem cell therapies for human and animal patients, today announced the publication of a new study that demonstrates the safety of autologous stem cell therapy in degenerative diseases and injuries.
The study, called “Safety Analysis of Autologous Stem Cell Therapy in a Variety of Degenerative Diseases and Injuries Using the Stromal Vascular Fraction,” is the largest safety trial to date that used stem cells from fat. It was published in the Journal of Clinical Medicine Research and co-authored by U.S. Stem Cell, Inc. Chief Science Officer Kristin Comella, PhD, as well as Michelle Parlo, PA, Rosemary Daly, DO, Vincent Depasquale, DC, Eric Edgerton, DC, Patrick Mallory, DO, Roy Schmidt, MD, Walter P. Drake, PhD.
“Our study demonstrates exceptional patient safety with low complication rates and underscores the safety of autologous stem cell therapy in general,” Dr. Comella said in a statement. “Few adverse events were reported and were overwhelmingly of mild and transient nature, such as the expected soreness at the site of liposuction and occasional headache.”
The study is the first trial to address cells from fat in multiple diseases and with different delivery routes. It describes the use of stromal vascular fraction (SVF) in the clinic for degenerative diseases in orthopedics, neurological and systemic conditions in 676 patients.
Stem cells from adipose tissue offer a novel therapy for patients with damaged tissue. SVF injected into patients may reduce inflammation, promote healing, and repair damaged/scarred tissue. SVF can be isolated from fat (adipose) tissue in a simple outpatient stem cell procedure that takes about 30-90 minutes and can be done under local anesthesia, using a mini-lipoaspirate technique. The stem cells can then be infused or injected after the mini-liposuction.
The new study demonstrates the strong safety profile from a multi-center analysis of SVF injection in treating various diseases. As part of the study, approximately 60 mL of fat tissue was removed from the abdomen or flanks using a local tumescent liposuction procedure. The fat was separated via centrifuge to isolate the SVF and the cells were delivered intraarticularly, intravenously, intrathecally, or intradiscally directly into the same patient. All subjects were monitored for adverse events.
U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. Since 1999, the company has completed more clinical treatments (for both humans and animals) than any other regenerative company in the world. U.S. Stem Cell, Inc. is focused on the discovery, development and commercialization of cell-based therapies that prevent or treat disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. U.S. Stem Cell, Inc. has also partnered with other companies to build a national distribution network for stem cell therapies using the U.S. Stem Cell, Inc. developed technologies and is on track to add an additional 10 stem cell treatment centers and clinics in the U.S.
About U.S. Stem Cell, Inc.
U.S. Stem Cell, Inc. is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell-based therapies that prevent or treat disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases, ultimately, we contend, lessening patient burdens, as well as reducing the associated economic impact disease imposes upon modern society.
Our business, which includes three operating divisions (U.S. Stem Cell Training, Vetbiologics and U.S. Stem Cell Clinic) includes the development of proprietary cell therapy products, as well as revenue generating physician and patient-based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.
Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue”, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.