BioRestorative Therapies Receives Approval to Conduct Retrospective Safety Study on its Bulging/Herniated Disc Procedure
Approval Granted by the Western Institutional Review Board
JUPITER, Fla., Aug. 6, 2013 /PRNewswire/ -- BioRestorative Therapies, Inc. ("BRT" or the "Company") (OTC BB: BRTX), a life sciences company focused on developing stem cell based cellular therapies for various personal medical applications, today announced that it has received approval from the Western Institutional Review Board ("the Board") to complete a retrospective safety study on selected subjects previously treated by the Company's brtxDISC™ bulging and herniated disc procedure. The study is titled "Re-consenting and Follow-Up of Adults from a Retrospective Study Using Autologous Transplantation of Marrow Derived Mesenchymal Stem Cells to Degenerated Intervertebral Disc."
Study objectives are to determine the safety of subjects who received transplants of their own stem cells into their disc, using MRI and Quality of Life Questionnaires. The Board requires that all subjects must be able to consent for themselves to be enrolled in the study, which has been approved to take place at the Centeno-Schultz Clinic in Broomfield, Colorado.
The approval allows BRT to retrospectively collect and analyze clinical data on selected subjects who previously have been treated for bulging or herniated disc disease with the Company's novel brtxDISC™ procedure. These procedures were performed using BRT's proprietary therapeutic delivery device cannula system and its proprietary culture method isolating a selective population of mesenchymal stem cells. BRT expects to complete the study within a six-month period.
"This is a significant milestone in taking our brtxDISC™ procedure closer towards an FDA meeting to seek approval for the commencement of our clinical trial. We look forward to collecting this data with the ambition of meeting the safety requirements necessary for us to receive approval and start our trial," commented Mark Weinreb, Chief Executive Officer of BioRestorative Therapies. "Our goal is to compile and present the necessary data to the FDA with the goal of initiating a Phase I or Phase II clinical trial in the early part of next year."
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. ("BRT"), www.biorestorative.com, develops medical procedures using cell and tissue protocols, primarily involving adult stem cells, designed for patients to undergo minimally invasive cellular-based treatments. BRT is developing the following scientific initiatives:
- brtxDISC™ Program (Disc Implanted Stem Cells), a non-surgical treatment for bulging and herniated discs that addresses the gap between non-invasive and invasive back procedures. This research is still in the non-clinical, investigational stage.
- ThermoStem® Program, a treatment for metabolic disorders (diabetes, heart disease, etc.) and obesity using brown fat stem cells. Initial non-clinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels in the body.
- brtx-C Cosmetic Program, based on the development of a human cellular extract that, per initial in vitro studies, when applied to human skin cells, appears to cause an increase in the production of collagen and fibronectin, which are proteins that are essential to combating the aging of skin. Potential cosmetic uses are being explored with third parties.
The Company also offers plant stem cell-based facial creams and beauty products under the Stem Pearls® brand at www.stempearls.com.
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including those set forth in the Company's Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.
SOURCE BioRestorative Therapies, Inc.
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