EXTON, Penn.--(BUSINESS WIRE)--Fibrocell Science, Inc. (NYSE MKT:FCSC), announced today positive results from a study demonstrating a potential mechanism for converting research-grade adult skin cells into clinical grade induced pluripotent stem (iPS) cells. The study, entitled “Generation and characterization of transgene-free human induced pluripotent stem cells and conversion to putative clinical-grade status” will be published in the peer-reviewed journal Stem Cell Research and Therapy. The provisional paper is available online at http://stemcellres.com/content/4/4/87/abstract. The study was conducted under the guidance of James Byrne, Ph.D., assistant professor, UCLA Department of Molecular and Medical Pharmacology, at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research.
“Generation and characterization of transgene-free human induced pluripotent stem cells and conversion to putative clinical-grade status”
In addition to providing proof of concept for this reprogramming method of converting adult skin cells to iPS cells, the study confirmed that researchers can effectively remove unwanted non-human contaminants from stem cell populations derived under research-grade conditions. A variety of tests were used to determine whether the converted stem cell population was viable, expressed markers identifying them as stem cells, was free of microorganisms and no longer expressed non-human contaminants. Positive test results proved that these stem cells were free of unwanted non-human factors.
The iPS cells generated from the study were also well-characterized, including confirmation of the ability to transform into other critical cell types such as those of the brain, liver and heart. The cells were converted to clinical grade in a UCLA facility that meets the requirements of current good manufacturing practices (cGMP) for producing personalized cellular therapies. The cellular characterization research, factor-free confirmation assays and cGMP manufacturing process are essential to the conversion of research-grade biologics into clinical-grade biologics.
“We are excited about our collaboration with UCLA and this important step forward as we continue to build our intellectual property portfolio around skin-derived iPS and neural stem cells—both of which hold potential for future discovery and development of autologous cellular therapeutics,” said David Pernock, Chairman and Chief Executive Officer of Fibrocell Science.
This reprogramming approach has the potential to be used by academic researchers and pharmaceutical companies to evaluate new drug compounds for safety and to develop patient-specific therapies for multiple disease states, including heart disease, Parkinson’s disease and diabetes. The "screening & cleaning" approach presented in this paper could become a standard tool to ensure iPS cell-derived products are free from non-human contaminants prior to autologous therapeutic use. Using skin cells is potentially more advantageous to patients than obtaining cells from bone marrow or adipose tissue (fat), since a skin biopsy is minimally invasive, less painful, and takes less time to perform—highlighting the value Fibrocell Science can bring to autologous cellular therapies.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (NYSE MKT:FCSC) is an autologous cell therapy company focused on the development of innovative products for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well as its innovative cellular processing technology and manufacturing excellence. The Company’s collaboration with the University of California, Los Angeles, is researching the conversion of dermal fibroblasts into pure functional human cell types that may have greater regenerative capacity. The collaboration is designed to set the stage for potential future diagnostics or treatments based on each person’s own cells for illnesses such as Parkinson’s disease, diabetes and heart disease. For additional information, please visit www.fibrocellscience.com.
All statements in this press release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, without limitation, the final discovery of a more predictable, commercially-viable method of producing stable, induced pluripotent stem cells (iPSC) and the ability of the Company to generate any future licensing opportunities based on the foregoing. While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company’s control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, as updated in “Item 1A. Risk Factors” in the Company’s Quarterly Reports on Form 10-Q filed since the annual report. The Company operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the Company’s public filings with the SEC.