Sports Medicine New Frontiers: Platelet-Rich-Plasma (PRP) and Stem Cell Therapy

CLEARWATER, Fla., May 20, 2013 /PRNewswire/ -- Sports Medicine is always at the forefront of innovative medical technology. Athletes are constantly striving to improve. Records are broken as humans run faster, jump higher, and strive for higher levels of performance. Athletes expose their bodies to more wear and tear as performance increases. Scientific training principles and diet have changed drastically over time. Technological breakthroughs have also impacted the rehabilitation process. The use of regenerative medicine has grown significantly in recent years. The popularity of Platelet-Rich-Plasma (PRP) has escalated as many high profile elite athletes from a diverse array of sports have opted for this treatment. The likes of Kobe Bryant, Rafael Nadal, and Tiger Woods garner ample press coverage when they are treated for injuries. Stem Cell Therapy becomes headlines when Peyton Manning undergoes this treatment. The goal of regenerative medicine therapies is to aid the body to heal itself. Understanding and accepting stem cell therapies for athletic injuries and sports medicine is gathering keen interest.

Dr. Dennis Lox, http://www.drlox.com a Sports and Regenerative Medicine Physician in the Tampa Bay Florida area, comments that the scientific backdrop of cell signaling and inflammatory mediators has led to a new understanding of how tissues heal. This also explains why injured tissues fail to heal, and is why the aging athlete recovers and heals more slowly than his younger counterpart. It is felt that the use of growth factors in Platelet-Rich-Plasma (PRP) is a localized cellular response to control negative repair processes and direct healing toward a positive restorative pathway. This directional approach to control repair, is more complex in stem cells, and as such, may be more effective for healing injured tissue. The stem cells are the body's repair cells that direct the necessary patterns of cellular messenger signals to target the repair process. It is not a simple chemical reaction where two chemicals react and one outcome results. There are a myriad of complicated molecules that interact to direct the repair process, and to counter the effects of a multitude of other molecules and signals regulating the breakdown or degradation of tissue. Dr. Lox points out, it is overcoming the many undesirable messages that occur with injury, whereby regenerative medicine may enhance sports injury recovery. Athletes are in need of rapid recovery to avoid losing peak conditioning. Aging athletes do not heal as effectively. Finding successful measures to aid the body in the healing naturally, is desirable for athletes and in preventing degenerative arthritis. Understanding the scientific rationale for the use of Platelet-Rich-Plasma (PRP) and Stem Cell Therapy, may pave the way for the expansive role for these treatments in future directions for athletic injury.

About Dr. Dennis Lox Dr. Lox practices in the Tampa Bay Florida area. Dr. Lox is a Sports and Regenerative Medicine Physician, who specializes in the use of regenerative and restorative medicine to assist in treating athletic and arthritis conditions. Dr. Lox may be reached at (727) 462-5582 or visit Drlox.com.

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Sports Medicine New Frontiers: Platelet-Rich-Plasma (PRP) and Stem Cell Therapy

BioRestorative Therapies Signs Agreement with Dexterity, Inc. to Advance Production of the Company's Novel brtxDISC™ …

JUPITER, Fla., May 20,2013 /PRNewswire/ --BioRestorative Therapies, Inc. ("BRT" or the "Company") (OTCBB: BRTX),a life sciences company focused on developing stem cell based therapies for various personal applications, announces the signing of a consulting agreement with Dexterity, Inc. ("Dexterity"). Dexterity is a product design and bioengineering firm that will provide services to further the development and production of BRT's proprietary therapeutic delivery device for its intervertebral disc stem cell therapy program, "brtxDISC," (Disc Implanted Stem Cells).

Dexterity's work is intended to advance the design and production of the disc therapeutic delivery device, towards a final version, to be eventually used in a clinical trial as a stem cell delivery system for the treatment of bulging and herniated discs. BRT expects to have a pre-IND/IDE meeting with the FDA to discuss the clinical trial by fourth quarter of this year.

The Company's brtxDISC program is being developed as an alternative to surgical intervention for patients suffering from bulging or herniated discs and could bridge the gap between non-invasive and invasive surgical back procedures. The therapy is a regeneration repair process using a patient's own stem cells that are implanted using BRT's proprietary therapeutic delivery device. The Company has data on treated humans in the U.S. and is compiling results in preparation for clinical trials in the U.S.

"We are very excited to be working with BioRestorative Therapies on the development of its novel, proprietary brtxDISC intervertebral disc stem cell therapy," commented Eric Simon, President of Dexterity. "Our experience with laparascopic and catheter-based devices, cell culture systems, and drug-delivery devices will assist in advancing the development and production of BRTX's disc stem cell delivery device as the company moves through its next phase of clinical trials."

"We are fortunate to be working with Dexterity," commented Mark Weinreb, Chief Executive Officer of BioRestorative Therapies. "With their depth of experience in 3D-CAD, biomaterials, and advanced prototyping and manufacturing, they are the perfect partner to work on the design and final engineering of our medical disc delivery device. We are confident our device will have the performance and quality to operate as intended and will be commercial-ready when we are able to launch our brtxDISC program."

About Dexterity, Inc.

Dexterity, Inc. is a full-service product design and development resource. The company has extensive experience in the design of tangible goods in the medical/biotechnical, consumer, and industrial markets. Dexterity specializes in 3D-Solids CAD modeling and analysis, employing rapid prototyping and tooling technologies to accelerate products to market. Dexterity's broad manufacturing experience assists its clients in designing toward the appropriate production technology for its clients and consumers needs. The company has designed and implemented a diverse range of medical and biotechnical products including in-vitro diagnostic systems, laparoscopic instrumentation, high-performance cell culture ware, drug-delivery devices, and various implantable products.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. ("BRT"), http://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:

The Company also offers plant stem cell-based facial creams and beauty products under the Stem Pearls brand at http://www.stempearls.com.

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BioRestorative Therapies Signs Agreement with Dexterity, Inc. to Advance Production of the Company's Novel brtxDISC™ ...

RNL BIO and Human Biostar to Offer Direct-to-Consumer Adult Stem Cell Banking in the United States

SEOUL, South Korea, May 20, 2013 /PRNewswire/ -- RNL BIO Co. Ltd., a stem cell biotechnology company dedicated to the commercialization of autologous cell therapyproducts for a variety of degenerative, ischemic and other indications, announces the availability of adult stem cell banking in the United States beginning on June 20, 2013. RNL BIO previously offered these services through another company, but will now provide the latest, safest technologies directly. As the sole global provider of its stem cell banking services, RNL BIO will provide clients with continuous quality assurance and constant innovation in adult stem cell technologies.

RNL BIO operates facilities in Maryland, Los Angeles and a FDA-registered stem cell banking facility in the Houston, Texas metroplex. It has opened a 15,000 square foot GMP laboratory facility in Sugar Land, Texas with extensive, state-of-the-art stem cell research and banking equipment, staffed by highly qualified scientists.

No human mesenchymal stem cell-based drug is presently approved for treatment in the United States. The only pathway to legal stem cell therapy is through FDA-approved clinical trials. RNL BIO has filed anInvestigational New Drug application (IND) with the Center for Biologics Evaluation and Research (CBER) atthe Food and Drug Administration (FDA) to begin clinical trials with its adipose-derived stem cell product,termed Jointstem, for the treatment of osteoarthritis (OA). Phase 2 clinical trials of Jointstem and another autologous stem cell-based biologic Vascostem (for treatment of Buerger's disease)have been completed under the authority of the Korean Food and Drug Administration (KFDA) in Seoul, Korea. Having reached this stage, RNL BIO filed New Drug Applications (NDA) to authorize the clinical use of these mesenchymal stem cell products in Korea. RNL BIO will be working with the FDA to determine what level of investigational availability is possible for its adult stem cell biologics in certain intractable and incurable diseases where no other therapeutic modality is available.

"We are happy to begin providing clients in the United States with our stem cell banking services," said Jeong-Chan Ra, Ph.D., the CEO and Chairman of RNL BIO. "We want to advance both banking and FDA-approved uses of stem cell technology." During 2011-13, RNL BIO has published its studies in more than 20 articles in major peer-reviewed journals. "We are following the pathways to regulatory approval so that our banking program can expand to include approved biologics for use in the United States and Europe."

ACCESS TO BANKING

RNL BIO provides stem cells to physicians whose patients request that they be obtained, however RNL BIO and Human Biostar are not offering stem cell therapeutics in the United States. RNL BIO is joining with U.S. hospitals and physicians in its banking services and to researchers in its bench and clinical trial activities.

About RNL Bio

RNL BIO is a South Korean biotechnology company focused on the research and development of adult derived stem celltechnologies. Its autologous, adipose-derived human mesenchymal stem cell technology, anchored by its unique stem cell culture media, is the subject of patents and patent applications in more than 30 nations and has been the subject of many scientific studies and peer-reviewed publications. The story of RNL BIO, its Chairman and its experiences with the use of stem cells in the clinical setting is the subject of the 2012 book, The grace of stem cells: a story of science and faith by J.C. Ra, available at bookstores and from Amazon.

Safe Harbor: This article may contain forward looking statements including projections and business trends. Actual results may differ materially from the anticipated results and expectations expressed in these forward-looking statements as a result of certain risks and uncertainties. These forward-looking statements are made based upon information available as of the date hereof, and the company assumes no obligation to update such forward-looking statements. Consequently, the reader is cautioned to consider all forward-looking statements in light of the risks to which they are subject.

For more information visithttp://www.rnl.co.kr/eng/main.asp, which is not part of this press release.

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RNL BIO and Human Biostar to Offer Direct-to-Consumer Adult Stem Cell Banking in the United States

Researchers' embryonic stem-cell advance decried as morally troubling

Washington

As Oregon scientists announced Wednesday they had successfully converted human skin cells into embryonic stem cells, the chairman of the U.S. bishops' Committee on Pro-Life Activities warned that the technique is morally troubling on many levels.

Scientists at the Oregon Health & Science University and the Oregon National Primate Research Center announced they had successfully reprogrammed human skin cells to become embryonic stem cells, which are capable of transforming into other types of cells that could replace those damaged by illness or injury.

Many news reports on the announcement referred to the research as human cloning, but the university's release and a full report on the work in Cell magazine carefully avoided the term, except to say taking the work in the direction of reproductive cloning is unlikely.

The Oregon research team developed the unfertilized embryonic cells to seven days' growth in a lab. Cardinal Sean O'Malley of Boston, who chairs the bishops' committee, said the process created and destroyed more than 120 human embryos, which the church considers human life that must be protected.

"Creating new human lives in the laboratory solely to destroy them is an abuse denounced even by many who do not share the Catholic Church's convictions on human life," O'Malley's statement said. He also decried the conditions to which the women who volunteered for the experiment were subjected to increase the number of eggs they produced, saying it "put their health and fertility at risk."

The researchers said their goal is to produce genetically matched stem cells for research and possible therapies, but O'Malley said the same goals can be achieved "by scientific advances that do not pose these grave moral wrongs."

Research using adult stem cells, or those derived after someone is born, as opposed to cells from embryos has provided promising possibilities for treating some illnesses or injuries. The reprogrammed stem cells can be used to replace damaged cells.

A statement from the university said the process announced Wednesday "is a variation of a commonly used method called somatic cell nuclear transfer. ... It involves transplanting the nucleus of one cell, containing an individual's DNA, into an egg cell that has had its genetic material removed. The unfertilized egg cell then develops and eventually produces stem cells."

Although the university's explanation of the breakthrough noted the research "does not involve the use of fertilized embryos, a topic that has been the source of a significant ethical debate," that doesn't address the Catholic church's moral objections.

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Researchers' embryonic stem-cell advance decried as morally troubling

Cytomedix to Present at the World Stem Cells & Regenerative Medicine Congress 2013

GAITHERSBURG, MD--(Marketwired - May 17, 2013) - Cytomedix, Inc. (OTCQX: CMXI), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that Edward Field, the Company's Chief Operating Officer, has been invited to make a presentation on Partnering & Collaboration at the World Stem Cells & Regenerative Medicine Congress 2013, which will be held May 21-23, 2013 in London, United Kingdom.

Presentation Details

Time: Tuesday, May 21, 2013 @ 11:55am BST (6:55 am EST)

Track Title: Commercialisation through Collaboration: What Does Partnering In This Industry Actually Look Like?

Location: Victoria Park Plaza Hotel, London, UK

During the presentation, Mr. Field will highlight Cytomedix's two collaborations that are advancing clinical stage therapies.The first is a collaboration with the National Institute of Health (NIH) and the Cardiovascular Cell Therapy Research Network (CCTRN) for conduct of the PACE study, an 80 patient, double-blind, placebo-controlled clinical trial designed to look at the safety and efficacy of ALD-301 in peripheral artery disease patients diagnosed with intermittent claudication.This is the first ever randomized clinical trial to look at the benefits of autologous stem cell therapy in this indication.The second collaboration is with Duke University Medical Center, which is conducting a Phase 1 clinical study with ALD-451 in patients that have been treated for glioblastomas, which is the most aggressive form of brain cancer.This open-label study is designed to enroll up to 12 patients and is intended to demonstrate the safety and feasibility of ALD-451 when administered intravenously in patients with grade IV malignant glioma following surgery, radiation therapy and treatment with temozolomide.

About the World Stem Cells Regenerative Medicine Congress 2013The World Stem Cells & Regenerative Medicine Congress 2013 is Europe's largest and most senior conference for the stem cell research and regenerative medicine community.It is now in its 8th year. Topics covered will include streamlining clinical development, commercialising a stem cell-based therapy and exploiting alternative sources of funding. For more information please visit: http://www.terrapinn.com/2013/stemcells/index.stm.

About Cytomedix, Inc. Cytomedix, Inc. is a fully integrated regenerative medicine company commercializing and developing innovative platelet and adult stem cell separation products that enhance the body's natural healing processes. The Company's advanced autologous technologies offer clinicians a new treatment paradigm for wound and tissue repair. The Company's patient-derived PRP systems are marketed by Cytomedix in the U.S. and distributed internationally. Our commercial products include the AutoloGel System, cleared by the FDA for wound care and the Angel Whole Blood Separation System. The Company is developing novel regenerative therapies using our proprietary ALDH Bright Cell ("ALDH") technology to isolate a unique, biologically active population of a patient's own stem cells. A Phase 2 trial evaluating the use of ALDHbr for the treatment of ischemic stroke is underway. For additional information please visit http://www.cytomedix.com.

Safe Harbor Statement - Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully execute its Angel and AutoloGel sales strategies, to achieve AutoloGel expected reimbursement rates in 2013, to meet its stroke trial enrollment rates, the Company's ability to successfully integrate the Aldagen acquisition, the Company's ability to expand patient populations as contemplated, its ability to provide Medicare patients with access as expected, the Company's expectations of favorable future dialogue with potential strategic partners, and its ability to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory 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. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2012, as amended to date, and other subsequent filings. These filings are available at http://www.sec.gov.

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Cytomedix to Present at the World Stem Cells & Regenerative Medicine Congress 2013

Stem-Cell-Based Strategy Boosts Immune System in Mice

UCSF Study Holds Promise for Treatment

Newswise Raising hopes for cell-based therapies, UC San Francisco researchers have created the first functioning human thymus tissue from embryonic stem cells, in the laboratory. The researchers showed that, in mice, the tissue can be used to foster the development of white blood cells the body needs to mount healthy immune responses and to prevent harmful autoimmune reactions.

The scientists who developed the thymus cells which caused the proliferation and maturation of functioning immune cells when transplanted said the achievement marks a significant step toward potential new treatments based on stem-cell and organ transplantation, as well as new therapies for type-1 diabetes and other autoimmune diseases, and for immunodeficiency diseases.

Starting with human embryonic stem cells, UCSF researchers led by Mark Anderson, MD, PhD, an immunologist, and Matthias Hebrok, PhD, a stem-cell researcher and the director of the UCSF Diabetes Center, used a unique combination of growth factors to shape the developmental trajectory of the cells, and eventually hit upon a formula that yielded functional thymus tissue.

The result, reported in the May 16, 2013 online edition of the journal Cell Stem Cell, is functioning tissue that nurtures the growth and development of the white blood cells known as T cells. T cells are a central immune cell population that responds to specific disease pathogens and also prevents the immune system from attacking the bodys own tissues.

The thymus might be a bit obscure to the layperson its a small gland at the top of the chest beneath the breastbone but it is in no way expendable, as individuals with defective thymus function succumb to infection early in life.

Given the invasive nature of cell therapy, which remains completely experimental, the first treatments using laboratory-derived thymus tissue would likely be studied in patients with fatal diseases for which there are no effective treatments, Anderson said. For example, one early treatment might be for the genetic disease DeGeorge syndrome, in which some newborns are born without a thymus gland and die in infancy.

However, a potentially greater impact may be in the area of tissue transplantation, a goal of the emerging field of stem-cell based therapies. Stem-cell-based therapies now are limited by the potential for the immune system to reject transplanted stem cells, Anderson said. For transplantation, stem cells might be coaxed down two developmental pathways simultaneously, to form both thymus tissue and a replacement organ. Transplantation of both might overcome the rejection barrier without the need for harmful immunosuppression, according to Anderson.

The thymus is an environment in which T cells mature, and where they also are instructed on the difference between self and non-self, Anderson said. Some T cells are prepared by the thymus to attack foreign invaders including transplants, while T cells that would attack our own tissues normally are eliminated in the thymus.

In the same vein, thymus tissue might one day be used to retrain the immune system in autoimmune diseases in which the immune system abnormally attacks self, thereby enhancing recognition and protecting from immune destruction.

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Stem-Cell-Based Strategy Boosts Immune System in Mice