NEW YORK, May 10 /PRNewswire-FirstCall/ -- Ortec International, Inc. , a company focused on development and commercialization of products applicable to regenerative medicine and stem cell therapy, today announced the results of experiments showing the ability of Fibrin Microbeads (FMB), an advanced fibrin based biomaterial, to isolate the Mesenchymal class of adult stem cells (MSC) from human peripheral blood. The research has been published in the May issue of the journal, Bone Marrow Transplantation. The stem cells isolated by attachment to FMB were shown to be able to expand and differentiate into cartilage (chondrocytes), fat (adipocytes) and bone (osteoblasts) forming cells. This finding is unique, since it was previously thought that adult MSC were not found in blood in any significant quantity. The results using FMB demonstrate that blood may indeed prove to be a useful source of these stem cells for therapeutic applications. FMB is one of two proprietary fibrin derived advanced biomaterial technologies recently acquired by Ortec.
Ron Lipstein, Vice Chairman and CEO of Ortec, commenting on the published results, said, "These experiments demonstrate that, contrary to the skepticism in the current scientific literature, FMB allow blood to be used as a source of all types of adult stem cells. Providing the capability to source mesenchymal stem cells from blood would obviate the need to rely solely on the more invasive and less available bone marrow or fat. The ability of FMB to isolate adult stem cells beyond the hematopoietic type is a unique and significant development in stem cell therapy. During the coming year we will look to broaden the significance and application of this unique aspect of the FMB technology."
Melvin Silberklang, Ph.D., Chief Scientific Officer of Ortec, added that, "These results highlight the unique ability of FMB to efficiently recover the mesenchymal type of stem cells from the most readily available body tissue, blood. This capability may make autologous stem cell therapy for tissue or organ regeneration as accessible as many other blood-based separation technologies that are available today."
The experiments, which were the basis of the published article, were conducted at Hadassah Hebrew University Medical Center, Jerusalem Israel. In these experiments FMB were used to isolate non-hematopoietic stem cells from mobilized peripheral blood of adult donors treated with granulate colony- stimulating factor (GCSF). Attempts to isolate these stem cells by standard isolation methods resulted in recovery of a negligible number of MSC in all blood samples tested. In contrast, the substantial number of such cells isolated using FMB stained positive for mesenchymal stem cell markers, expressed vimentin and fibronectin and were negative for hematopoietic markers. They were also able to expand on the FMB or on plastic in eight out of the eleven samples tested.
Previously published results showed the ability of FMB to isolate and expand mesenchymal adult stem cells from mouse and rat bone marrow at a yield which is 3 to 5 times that of conventional isolation techniques, and showed that those isolated cells were able to form bone structures both in vitro and in vivo.
About Ortec International, Inc.
Ortec International, Inc. (ORTN) is a company focused on advancing regenerative medicine and stem cell therapy through the development and commercialization of innovative products by combining advanced cell technology and advanced biomaterials. Ortec's lead product is OrCel(R) (Bilayered Cellular Matrix). Ortec's current focus is the application of OrCel(R) to heal chronic and acute wounds. OrCel(R) is composed of a collagen sponge seeded with allogeneic epidermal and dermal cells. These cells secrete growth factors and cytokines normally found in acute human wounds and are believed to have a beneficial role in promoting tissue repair.
A pivotal clinical trial evaluating a cryopreserved version of OrCel(R) in the treatment of venous leg ulcers has been completed and a Pre Market Approval (PMA) application has been filed. Ortec has recently completed patient enrollment in a confirmatory trial and the data from this trial are expected to be integrated with the results of the pivotal clinical trial and submitted as a clinical supplement to its PMA filing. Ortec has already obtained FDA approvals for use of a non-frozen version of OrCel(R) in the treatment of Epidermolysis Bullosa and donor sites in burn patients. In addition, the FDA has granted Ortec approval to initiate a pivotal (Phase III) trial evaluating OrCel(R) for the treatment of diabetic foot ulcers.
Ortec recently acquired two fibrin derived advanced biomaterial technologies, Fibrin Microbeads (FMB) and Haptides(TM). FMB have the potential to play a significant role in advancing stem cell therapy having demonstrated the ability to efficiently recover adult stem cells and allow for their growth, proliferation, and potential reimplantation into the patient. Haptides(TM) utilize proprietary synthetic peptides that mimic the mechanism of cell attachment to fibrin. These peptides have demonstrated the ability to significantly enhance cell attraction and attachment providing the potential to use Haptides(TM) in the development of product opportunities applicable to the cosmetic tissue augmentation, wound healing, orthopedics, and drug delivery markets
For more information, visit Ortec's website at http://www.ortecinternational.com .
This news release may contain "forward-looking statements" for the purposes of the United States Securities and Exchange Commission's "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995 and Rule 3B-6 under The Exchange Act. Without limitation, statements regarding expected FDA approvals, clinical trial results, product performance, expectations with respect to sales, gross margins, research and development expenditures, earnings per share, capital expenditures, collaborations, or other expansion opportunities would be "forward-looking statements." These statements may be identified by words such as "expects," "anticipates," "intends," "estimates," "believes" or similar expressions in connection with any discussion of future financial and operating performance. The forward- looking statements contained herein involve risks and uncertainties that may cause results to differ materially from the Company's expectations including but not limited to, global economic trends, competitive pricing or product developments, government legislation and/or regulations, technology, manufacturing, legal and patent issues, suppliers, capital availability, personnel changes, cancellation or delays in renewal of contracts, and lack of suitable raw materials or packaging materials. Investors are cautioned to review risk factors in the Company's filings with the United States Securities and Exchange Commission.
FOR MORE INFORMATION, PLEASE CONTACT Elite Financial Communications Group, LLC Dodi Handy, 407-585-1080 or via email at ortn@efcg.net
Ortec International, Inc.CONTACT: Dodi Handy, Elite Financial Communications Group, LLC,+1-407-585-1080, or ortn@efcg.net, for Ortec International, Inc.
Web site: http://www.ortecinternational.com/
