Promising results from study on generation of clinical grade iPS cells.
EXTON, Penn., August 19, 2013--Fibrocell Science, Inc. (NYSE MKT: FCSC), announced positive results from a UCLA study demonstrating a potential mechanism for converting research-grade adult skin cells into clinical grade induced pluripotcnt stem (iPS) cells.
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 biologies into clinical-grade biologies.
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.
The study, entitled "Generation and characterization of transgcnc-frcc human induced pluripotcnt stem cells and conversion to putative clinical-grade status", will be published in Stem Cell Research and Therapy.
The study was conducted under the guidance of James Byrne, Ph.D., assistant professor, UCLA Department of Molecular and Medical Pharmacology.
http://stcmccllrcs.eom/contcnt/4/4/87/abstract Contact: http://www.fibrocellscience.com
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|Title Annotation:||Advanced stem cell technology|
|Publication:||Stem Cell Business News|
|Article Type:||Clinical report|
|Date:||Sep 9, 2013|
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