Newswise New Brunswick, N.J., May 15, 2012 With recent advancements in technology and biomedical informatics, a more personalized approach to prescribing cancer treatment and developing these therapies is preferred over one-size-fits-all methods. The Cancer Institute of New Jersey (CINJ) has been on the cutting-edge of this movement and is now launching a more concrete effort that is poised to change the way that molecular and genetic information is being used to diagnose and treat cancer an initiative known as precision medicine also known to many as personalized medicine. CINJ is a Center of Excellence of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School.

Research has shown that cancer is not one disease, but rather a collection of diseases. Each cancer sub-type boasts its own individual molecular makeup, which in many cases results in cancer growth and resistance to cancer-killing drugs. By further defining the molecular profile of various cancer subtypes, investigators hope to apply this information toward developing targeted therapies. Large scale efforts on the national and local levels including those at CINJ have been underway to collect correlating clinical and genomic data to use as a road map in determining diagnosis, prognosis and course of treatment. With CINJs newly-established precision medicine initiative, specialized investigators will further integrate that information using state-of-the-art technology to better catalogue and expedite the flow of data from researcher to doctor to patient and in turn back to the researcher.

Leading CINJs initiative for precision medicine is Lorna Rodriguez, MD, PhD, who served as CINJs chief of gynecologic oncology from 2000 until this year before being asked to take on this new role. Dr. Rodriguez has years of experience running her own investigator-initiated clinical trials including research on cancer metastasis, drug resistance and the CD44 cell surface receptor and the role it plays in ovarian cancer metastasis. She feels the impact of precision medicine both on patients and on the health/biomedical communities will be tremendous. For the most part, clinicians are forced to rely on limited information to make treatment decisions, as there hasnt been a mechanism to collect and catalogue such comprehensive data as tissue samples, patient history and treatment records to create the tumor profiles necessary for more personalized treatments, noted Rodriguez, who is also a professor of obstetrics, gynecology and reproductive sciences at UMDNJ-Robert Wood Johnson Medical School. By compiling and further curating a collection of molecular and genetic data that will help drive new targeted therapies, we will be helping patients better manage their disease.

This also will translate into cost savings, as no longer will doctors need to rely on hit-or-miss medicine, continued Rodriguez, who also performs gynecologic cancer surgeries and helps patients navigate chemotherapy options. Currently, if one treatment is found to be ineffective, others are used -- and they come at a cost, both financially and in terms of lost time when the patient might have received effective treatment. With the prospects of precision medicine, we are moving closer to an era where we will be able to tailor cancer treatments to perfectly fit individualized patient profiles. This will also lead us to a better understanding in diagnosing disease and providing a prognosis.

The breast cancer drug trastuzumab is one example of how genomic information is helping to drive targeted cancer therapies. Study has shown that trastuzumab is effective for 20 percent of breast cancer patients whose cancer cells make too much of the HER2-positive protein. Because a genetic test can indicate whether a patient has the HER2-positive profile, doctors can better determine whether trastuzumab might be an effective treatment for them.

About The Cancer Institute of New Jersey The Cancer Institute of New Jersey (www.cinj.org) is the states first and only National Cancer Institute-designated Comprehensive Cancer Center dedicated to improving the detection, treatment and care of patients with cancer, and serving as an education resource for cancer prevention. CINJs physician-scientists engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life. To make a tax-deductible gift to support CINJ, call 732-235-8614 or visit http://www.cinjfoundation.org. CINJ is a Center of Excellence of the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School. Follow us on Facebook at http://www.facebook.com/TheCINJ.

The CINJ Network is comprised of hospitals throughout the state and provides the highest quality cancer care and rapid dissemination of important discoveries into the community. Flagship Hospital: Robert Wood Johnson University Hospital. System Partner: Meridian Health (Jersey Shore University Medical Center, Ocean Medical Center, Riverview Medical Center, Southern Ocean Medical Center, and Bayshore Community Hospital). Major Clinical Research Affiliate Hospitals: Carol G. Simon Cancer Center at Morristown Medical Center, Carol G. Simon Cancer Center at Overlook Medical Center, and Cooper University Hospital. Affiliate Hospitals: CentraState Healthcare System, JFK Medical Center, Robert Wood Johnson University Hospital Hamilton (CINJ Hamilton), Somerset Medical Center, The University Hospital/UMDNJ-New Jersey Medical School*, and University Medical Center at Princeton. *Academic Affiliate

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Cancer Institute of New Jersey Aims to Advance Personalized Cancer Treatments Through 'Precision Medicine'

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Instead of operating on the spine itself, the surgeons rerouted working nerves in the upper arms. These nerves still "talk" to the brain because they attach to the spine above the injury.

Following the surgery, performed at Barnes-Jewish Hospital, and one year of intensive physical therapy, the patient regained some hand function, specifically the ability to bend the thumb and index finger.

The unnamed patient can now feed himself bite-size pieces of food and write with assistance.

"This procedure is unusual for treating quadriplegia because we do not attempt to go back into the spinal cord where the injury is," says surgeon Ida K. Fox, MD, assistant professor of plastic and reconstructive surgery at Washington University.

"Instead, we go out to where we know things work, in this case the elbow, so that we can borrow nerves there and reroute them to give hand function."

The surgery was developed and performed by the study's senior author Susan E. Mackinnon, MD, chief of the Division of Plastic and Reconstructive Surgery at Washington University School of Medicine.

Specialising in injuries to peripheral nerves, she has pioneered similar surgeries to return function to injured arms and legs.

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Paralysed man regains use of hand after operation

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Bob Langer, co-inventor of technology used by InVivo

Spinal cord injury treatment company InVivo Therapeutics Holdings Corp. (OTCBB:NVIV) reported a profit for the first quarter of 2012, and said its biopolymer scaffolding is slated to enter human clinical trials later this year.

InVivo shares were up about 6 percent in mid-morning trading to $2.45.

The company said it expects to start a pilot human clinical trial of the scaffolding in the second half of 2012, pending approval of an Investigational Device Exemption application by the U.S. Food and Drug Administration. Following a meeting with the FDA held in April, the company said it is expecting the product to be regulated under the Humanitarian Use Device/Humanitarian Device Exemption pathway that should accelerate commercialization.

The Cambridge company uses technology co-invented by MIT Professor Robert Langer and Mass General Hospitals Dr. Joseph P. Vacanti. Langer was among the team of InVivo scientists who met with the FDA in April.

The pilot test will be an open label study to evaluate the safety and efficacy in spinal cord injury patients following treatment with the biopolymer scaffolding. The study will follow promising pre-clinical studies completed in non-human primates, according to InVivo.

The company also expects this year to file with the FDA for its injectable hydrogel to treat peripheral nerve and spinal cord injuries. The company is conducting a preclinical study with Geisinger Health System to evaluate the injectable biocompatible hydrogel for the treatment of pain caused by peripheral nerve compression. Some 3.2 million pain injections are performed annually to treat back, neck and leg pain caused by peripheral nerve injuries. InVivos hydrogel is designed to time-release anti-inflammatory drugs for extended pain relief. The product addresses an estimated $15 billion market for peripheral nerve injuries, the company said.

We are off to a strong start for 2012 and the first quarter was marked by significant achievements and milestones for InVivo, Frank Reynolds, InVivos CEO, said in a prepared statement. By the end of 2012, we expect to have several product applications under review by the FDA.

He added that during the first quarter of 2012, InVivo strengthened its balance sheet by closing an oversubscribed $20 million public offering. Net proceeds to InVivo were approximately $18.1 million. InVivo also has the potential to receive an additional $18.6 million of capital from the exercise of previously issued outstanding warrants.

InVivo also has signed a multi-year lease for a 21,000 square foot facility at One Kendall Square in Cambridge that will house corporate offices, a vivarium, laboratory space and a current good manufacturing practices cleanroom for manufacturing.

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InVivo reports profit, expects to start human trial

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Surgical Procedure May Benefit Some Spinal Cord Injury Patients

May 15, 2012 -- Surgeons in St. Louis have restored partial function to a 71-year-old man's hands, which had been paralyzed following a spinal cord injury sustained in a car accident two years before the surgery.

The man, who remains paralyzed from the waist down, can now write and feed himself. A case report published today in the online edition of the Journal of Neurosurgery describes the procedure.

"This is not a small step, this is a significant step," says UCLA neurosurgeon Nader Pouratian, MD, a specialist in nerve and movement disorders who was not involved in the case. "It is a novel application of an established surgical technique. It goes beyond what we thought was possible before."

The established technique that Pouratian refers to is one in which working nerves taken from one muscle replace damaged nerves in another. Such nerve transfers can restore arm and shoulder movement following what's called peripheral nerve injury, for example.

In this case, however, the damage was not to the nerve. It was to the spine.

"The nerve and muscle were still healthy, but the spine injury was blocking communication with the brain," says Ida Fox, MD, a plastic and reconstructive surgeon at Washington University School of Medicine in St. Louis and a colleague of the surgical team that performed the operation.

The patient's injury had left him without the use of his hands, but he retained a good deal of upper body function. That gave his medical team, led by Susan E. Mackinnon, MD, a pioneer in nerve transfer techniques, some materials to work with. They focused on the nerves that control elbow movement.

One of those nerves, the brachialis nerve, is considered to be redundant. That is, another nerve performs the same job, so no function would be lost if the brachialis nerve were to be moved. That allowed the surgeons to take it and attach it to the anterior interosseous nerve, which controls the thumb and the index finger.

"They're basically stealing a nerve and plugging it into another nerve that is below the level of the spinal injury," says Lewis Lane, MD, chief of hand surgery at North Shore University Hospital and Long Island Jewish Medical Center in New York. Lane was not involved with the surgery.

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Paralyzed Man's Hand Movement Partially Restored

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ScienceDaily (May 15, 2012) Surgeons at Washington University School of Medicine in St. Louis have restored some hand function in a quadriplegic patient with a spinal cord injury at the C7 vertebra, the lowest bone in the neck. Instead of operating on the spine itself, the surgeons rerouted working nerves in the upper arms. These nerves still "talk" to the brain because they attach to the spine above the injury.

Following the surgery, performed at Barnes-Jewish Hospital, and one year of intensive physical therapy, the patient regained some hand function, specifically the ability to bend the thumb and index finger. He can now feed himself bite-size pieces of food and write with assistance.

The case study, published online May 15 in the Journal of Neurosurgery, is, to the authors' knowledge, the first reported case of restoring the ability to flex the thumb and index finger after a spinal cord injury.

"This procedure is unusual for treating quadriplegia because we do not attempt to go back into the spinal cord where the injury is," says surgeon Ida K. Fox, MD, assistant professor of plastic and reconstructive surgery at Washington University, who treats patients at Barnes-Jewish Hospital. "Instead, we go out to where we know things work -- in this case the elbow -- so that we can borrow nerves there and reroute them to give hand function."

Although patients with spinal cord injuries at the C6 and C7 vertebra have no hand function, they do have shoulder, elbow and some wrist function because the associated nerves attach to the spinal cord above the injury and connect to the brain. Since the surgeon must tap into these working nerves, the technique will not benefit patients who have lost all arm function due to higher injuries -- in vertebrae C1 through C5.

The surgery was developed and performed by the study's senior author Susan E. Mackinnon, MD, chief of the Division of Plastic and Reconstructive Surgery at Washington University School of Medicine. Specializing in injuries to peripheral nerves, she has pioneered similar surgeries to return function to injured arms and legs.

Mackinnon originally developed this procedure for patients with arm injuries specifically damaging the nerves that provide the ability to flex the thumb and index finger. This is the first time she has applied this peripheral nerve technique to return limb function after a spinal cord injury.

"Many times these patients say they would like to be able to do very simple things," Fox says. "They say they would like to be able to feed themselves or write without assistance. If we can restore the ability to pinch, between thumb and index finger, it can return some very basic independence."

Mackinnon cautions that the hand function restored to the patient was not instantaneous and required intensive physical therapy. It takes time to retrain the brain to understand that nerves that used to bend the elbow now provide pinch, she says.

Though this study reports only one case, Mackinnon and her colleagues do not anticipate a limited window of time during which a patient with a similar spinal cord injury must be treated with this nerve transfer technique. This patient underwent the surgery almost two years after his injury. As long as the nerve remains connected to the support and nourishment of the spinal cord, even though it no longer "talks" to the brain, the nerve and its associated muscle remain healthy, even years after the injury.

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EXTON, Pa.--(BUSINESS WIRE)--

Fibrocell Science, Inc. (OTCBB:FCSC.OB) announced today the formation of the Clinical Investigations for Dermal Mesenchymally-Obtained Derivatives (CIDMOD) Initiative (www.CIDMOD.org) in collaboration with researchers from a number of different universities across the U.S. The CIDMOD Initiative will facilitate the collaboration of scientists, clinical researchers and private entities, including Fibrocell, to secure funding that will advance clinical research programs that may one day lead to new personalized cell therapies or diagnostic tools for a variety of diseases and conditions. The group will also submit grant requests to the California Institute of Regenerative Medicine (CIRM) and seek additional funding for the development of clinical research programs that use Fibrocells deep knowledge and expertise in cell isolation, purification and expansion via use of its proprietary technology.

Fibrocell Science is excited to support the CIDMOD Initiative. We believe the future work conducted by the Initiatives members will positively impact Fibrocells overall stem cell research strategy and significantly impact the future of personalized medicine, said David Pernock, Chairman and CEO of Fibrocell Science, Inc.

Co-directors of the CIDMOD Initiative include:

About Fibrocell Science Technology

Fibrocell Science has developed an innovative technology to isolate, purify and multiply a patients own fibroblast cells (a type of skin cell that makes collagen) for injection. Initially, this patented, proprietary technology was applied for use via the companys first product on the market, LAVIV (azficel T). The technology is also being used to study the composition of skin tissue samples to identify, isolate, purify and multiply specialized dermal cell types, such as mesenchymal stem cells (MSCs) and SSEA3-expressing regeneration-associated (SERA) cells. SERA cells may play a role in the regeneration of human skin in response to injury, and MSCs are being investigated for their ability to differentiate into cells that can form bone, cartilage and fat. Finding these specialized cells within skin cell cultures is important because rather than undergoing a surgical organ or tissue transplantation to replace diseased or destroyed tissue, patients may one day be able to benefit from procedures by which stem cells are extracted from their skin, differentiated into specific cell types, and re-implanted into their bodies to exert a therapeutic effect.

About Fibrocell Science, Inc.

Fibrocell Science, Inc. (OTCBB:FCSC.OB) is an autologous cellular therapeutic 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. For additional information, please visit http://www.fibrocellscience.com.

Forward-Looking Statements

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, whether the Initiative will be successful in securing funding, and whether future work conducted by the Initiatives members will positively impact Fibrocells overall stem cell research strategy and significantly impact the future of personalized medicine. 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, 2011, 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.

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Fibrocell Science, Inc. and Top University Investigators Form Scientific Initiative to Assist in Securing Grant ...

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ALACHUA, Fla.--(BUSINESS WIRE)--

AxoGen, Inc. (AXGN.OB), a leading regenerative medicine company focused on the commercialization of proprietary products and technologies for peripheral nerve reconstruction and regeneration, today announced revenues for the first quarter ended March 31, 2012 of $1.65 million, a 47% increase over 2011 first quarter revenues of $1.12 million.

This quarters record performance has been the direct result of our increase in sales and marketing activity, commented Karen Zaderej, Chief Executive Officer of AxoGen, Inc. During the first quarter we continued to expand our sales force, while continuing to get hospital approval for AxoGen products and training and developing the sales team. Our growing base of sales representatives, combined with increasing surgeon awareness of our technologies and clinical data, creates a strong environment for our continued growth.

Revenues Revenues for the period increased to a record $1.65 million, or 47%, compared to $1.12 million in 2011. The improved results were primarily due to an increase in new accounts as well as stronger sales penetration into key accounts.

Revenues increased 21% over fourth quarter revenues of $1.36 million.

Gross Profit Gross profit reached $1.21 million, a 55% increase, for first quarter 2012 up from $0.78 million reported for the same period 2011. The higher gross profit reflects lower manufacturing and labor cost and the absence of one-time manufacturing startup expenses reported during the first quarter of 2011. The gross profit margin increased to 73% compared to 70% for the same quarter last year.

Sales and Marketing Expenses As a result of the Company's investment in additional sales and marketing resources, sales and marketing expenses during the first quarter of 2011 increased to $1.63 million, compared to $0.86 million reported during the same period last year. As of the end of the period, the Company reported 16 direct and 21 independent sales representatives and distributors.

Research and Development Expenses Research and development expenses increased to $0.30 million during the first quarter of 2012. Substantially all of the research and development expenses relate to expenditures for clinical activity.

General and Administrative Expenses General and administrative expenses increased to $1.23 million for the quarter, compared to $0.72 million reported last year. This increase was largely driven by payroll and benefit increases and expenses associated with being a public company.

Operating Loss The Company reported a net loss of $2.11 million, or $0.19 per common share, compared to a net loss of $2.3 million, or $2.21 per common share, reported during the same period in 2011.

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AxoGen, Inc. Announces Record First Quarter 2012 Revenues

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WALTHAM, Mass.--(BUSINESS WIRE)--

Regenerative medicine company Histogenics Corporation, announced today the presentation of intermediate term data supporting the clinical efficacy of the Companys NeoCart Autologous Cartilage Tissue Implant (ACTI) for periods of up to five years with no evidence of severe treatment-related adverse events in patients with grade III chondral injury to the femur (cartilage damage in the knee). Dennis Crawford,M.D., Ph.D.,Assistant Professor and Surgical Director of Sports Medicine Programs in the Department of Orthopedics and Rehabilitation at Oregon Health Science University presented the findings An Autologous Cartilage Tissue Implant (ACTI) NeoCart for Treatment Grade III Chondral Injury to the Femur. Intermediate Term Results from Initial FDA Trials. at the International Cartilage Repair Society (ICRS) 2012 Annual Meeting in Montreal Canada on Sunday, May 13, 2012. NeoCart is an autologous bioengineered neocartilage grown outside the body using the patients own cells for the repair of full thickness cartilage lesions.

These results suggest that NeoCart has significant potential to act as a first-line surgical treatment option for focal cartilage repair or replacement and, as such, may provide an alternative to microfracture type procedures, said Dr. Crawford. For the patients in this cohort with knee cartilage injuries treated with NeoCart, we reported improvement in all patient reported outcomes as soon as six months following surgery, as patients were released to full activity, and these therapeutic gains weresustained throughout a median study period of 48 months. The first patients treated with NeoCart have had similar gains for five years. These improvements are seen across a spectrum of validated, ICRS-recommended outcome measures, including pain, function and associated activity of daily living performance.

This analysis continues to add to an already impressive NeoCart data set and further supports our ongoing Phase 3 study, said Patrick ODonnell, President and Chief Executive Officer of Histogenics. There is clearly a need in the market for longer-term, effective solutions for cartilage injury and we are hopeful that NeoCart may be able to play a role in filling this treatment void.

The primary purpose of the analysis was to summarize the safety and efficacy experience of all patients treated with NeoCart up to five years using ICRS-recommended patient reported scores, as well as general health assessments. Subjects were pooled from previously-completed, Company-sponsored Phase 1 and 2 multi-center clinical trials. Eligible patients were between the ages of 18-55 years of age and had one or two symptomatic ICRS grade III chondral lesion(s) on the femoral condyle. Validated and ICRS-recommended patient reported outcome measures were obtained at each follow up visit. These included the following: Knee Injury and Osteoarthritis Outcome Score, Visual Analog Scale, Short Form Health Survey, and International Knee Documentation Committee subjective. Serious and adverse events were recorded for all patients. Data on twenty-nine patients was reported in the cohort, including eight patients through 60 months and 20 patients at a minimum of 36 months; one patient was lost to follow up after 12 months. The median follow up time period was 48 months.

Significant improvement (p<0.0001) was seen in the mean measures of all patient reported outcomes across all time points up to four years and at final follow up for each patient. Measures included the International Knee Documentation Committee, Short Form Health Survey, all five domains of the Knee injury and Osteoarthritis Outcome Score and the Visual Analog Scale (VAS) average and highest. Significant decreases from baseline (p<0.05) were reported for average VAS pain scores (1718, p=0.031) at six weeks and for highest VAS pain scores at three months (2331, p=0.004), and sustained through final visit (p<0.0001) for both. Range of motion did not decrease in any patient and, in fact, improved with a mean change from baseline of 68 degrees at final follow-up (p<0.001). Serious adverse events were limited to four and not related to the implant.

About NeoCart

NeoCart is an autologous bioengineered neocartilage grown outside the body using the patients own cells for the regeneration of cartilage lesions. NeoCart recently entered a Phase 3 clinical trial after reporting positive Phase 2 data, in which all primary endpoints were met and a favorable safety profile was demonstrated.

About Histogenics

Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company Prochon BioTech. Histogenics flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts, and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement, including lead candidates NeoCart, an autologous bioengineered neocartilage grown outside the body using the patients own cells for the regeneration of cartilage lesions, and VeriCart, a three-dimensional cartilage matrix designed to stimulate cartilage repair in a simple, one-step procedure. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implants effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. For more information, visitwww.histogenics.com.

Link:
Histogenics’ NeoCart for Patients with Knee Cartilage Damage Demonstrates Continued Efficacy for Periods of Up to Five ...

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DENVER, May 14, 2012 /PRNewswire/ -- Regenerative Sciences, Inc., a company dedicated to advancing orthopedic care through non-surgical adult stem cell procedures, today announced that it has secured a $2M investment from philanthropist, visionary and businessman John C. Malone, PhD, chairman of Liberty Media Corporation. In addition to advancing Regenerative Sciences' clinical and lab-based stem cell research, the investment will help support the national expansion of their Regenexx Physician Network.

Regenerative Sciences' Regenexx procedures utilize a patient's own stem cells to help repair a broad range of common injuries and degenerative conditions, including cartilage lesions, torn ligaments and tendons, osteoarthritis and bulging spinal discs. For many, the procedures offer a viable alternative to arthroscopic surgery, open-joint surgery, or joint replacement surgery. Regenexx patients experience little or no downtime from the procedures and avoid the lengthy rehabilitation period associated with most surgical procedures.

"We are proud of our accomplishments in the field of regenerative interventional orthopedics and it's exciting that our work has drawn the attention of such a noted entrepreneur and philanthropist," said Christopher J. Centeno, M.D., Chief Executive Officer of Regenerative Sciences. "Dr. Malone shares our vision for forging the next generation of minimally invasive regenerative treatments. This investment will not only bolster our existing stem cell research programs and make our procedures available in all regions of the U.S., but it will help us maintain a leadership role in clarifying the regulatory space for physician stem cell use."

Regenerative Sciences is at the forefront of regenerative orthopedic medicine within the United States and the company is bringing the future of orthopedic treatments to patient care today.

About Regenerative Sciences

Regenerative Sciences is an outgrowth of the Centeno-Schultz clinic, where we are reinventing orthopedic care for the 21st century using key biologics such as stem cells, next generation tools and devices, and unique therapeutic approaches. Our signature initiative, Interventional Orthopedics, allows doctors to treat orthopedic conditions through injection, rather than traditional invasive surgery. The Regenexx Physician Network brings together like-minded physicians from around the country to offer more patients access to our innovative procedures. For more information on Regenerative Sciences and Regenexx procedures, visit: http://www.regenexx.com

About John C. Malone, PhD

Dr. John C. Malone holds a bachelor's degree in electrical engineering and economics from Yale University, where he was a Phi Beta Kappa and merit scholar. He also holds a master's degree in industrial management and a Ph.D. in operations research from Johns Hopkins University.

Dr. Malone is Chairman of Liberty Media Corporation, a position he has held since 1990. Dr. Malone is also the Chairman of the Board of Liberty Global, Inc. (LGI), a position he has held since June, 2005. From 1996 to March 1999 when Tele-Communications, Inc. (TCI) merged with AT&T Corp., he was also Chairman and Chief Executive Officer of TCI. Previous to that, from 1973 to 1996, Dr. Malone served as President and CEO of TCI. He currently serves on the Board of Directors for CATO Institute, Expedia, Inc., Discovery Communications, Inc., and SiriusXM.

Contact:

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Regenerative Sciences Receives $2M Investment for Orthopedic Stem Cell Initiatives

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NORTHRIDGE, Calif. & CAMBRIDGE, England--(BUSINESS WIRE)--

Avita Medical Ltd. (ASX: AVH), (OTC: AVMXF), (OTCQX: AVMXY),the regenerative medicine company, today announced that it has commenced enrolment in the US FDA-approved feasibility study for the use of ReCell Spray-On-Skin in the treatment of hypertrophic dyspigmented scars (raised and/or discoloured scars).

The initial three patients were treated by Dr Rajiv Sood, at the Richard M. Fairbanks Burn Center of Wishard Hospital, Indiana University, Indianapolis, Indiana, for scarring resulting from previous grafting due to burn injuries.

The approved FDA protocol permits the Company to treat 20 patients with scars at up to four U.S. study sites; patients will be assessed for healing and pain on a weekly basis during the initial four weeks post-treatment; at weeks 12 and 24 the treatment site will be assessed for healing and aesthetic outcomes by both the patient and an independent observer.

"Commencement of the FDA scar study is an important milestone for Avita," said Dr William Dolphin, Avita Medicals CEO. "ReCell has shown the potential to provide significant benefits over current options in the treatment of acute and chronic wounds and for a wide range of skin defects. We are confident that this study will demonstrate the effectiveness of ReCell in the corrective treatment of scars, making ReCell directly applicable and immediately relevant to the very large aesthetic markets.

The feasibility study is primarily designed to confirm the effectiveness of ReCell for the treatment of scars in a single session in comparison to the current standard of care involving dermabrasion of the scar and often requiring multiple treatment sessions; study endpoints are time-to-healing and aesthetic outcomes. Following completion of the study, Avita will submit the feasibility data and seek FDA approval for a statistically powered, pivotal clinical trial.

The study is funded by the US Department of Defense in partnership with the OSD Manufacturing Technology Program and Rapid Fielding Directorate for the Limb Salvage and Regenerative Medicine Initiative. The contract is a Technology Investment Agreement that is focused on the transition of the capability to meet DoD needs. ReCell was selected as it has the potential to be a quantum advance over the existing ability to treat and re-grow tissue and to substantially reduce the effects and appearance of scarring and thereby profoundly assist in the treatment and rehabilitation of wounded warriors suffering from disfigurement and impeded function due to combat injuries.

An interview with Dr Sood regarding the use of ReCell in treatment of scars and acute wounds is available at http://soundmedicine.iu.edu/segment/3245/Spray-on-Skin.

ABOUT AVITA MEDICAL LTD.

Avita Medical (www.avitamedical.com) develops and distributes regenerative and tissue-engineered products for the treatment of a broad range of wounds, scars and skin defects. The companys lead product, ReCell Spray-On-SkinTM, is used in a wide variety of burns, plastic, reconstructive and cosmetic procedures. ReCell is patented, CE-marked for Europe, TGA-registered in Australia, and SFDA-cleared in China. ReCell is not available for sale in the United States; in the U.S. ReCell is an investigational device limited to investigational use.

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Avita Medical Initiates US FDA Study of Its ReCell® Spray-On-Skin™ for Reconstructive and Aesthetic Indications

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Regenerative medicine startup Juventas Therapeutics has begun enrollment in a phase 2a trial of critical limb ischemia patients.

The Cleveland-based company, which recently secured an important investment from Takeda Pharmaceuticals, is planning to enroll 48 patients and complete enrollment early next year, CEO Rahul Aras said.

Juventas technology, called JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. Its based on Stromal Cell-Derived Factor-1 (SDF-1), a naturally produced molecule that attempts to repair the heart immediately following a heart attack.

Critical limb ischemia (CLI) patients are enrolling at several U.S. hospitals, as well as three in India. CLI is a severe obstruction of the arteries that greatly decreases blood flow to the extremities.

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CLI has become a very exciting clinical opportunity, Aras said. Its becoming a growing area of interest for a number of biotech and pharma companies.

Other companies pursuing CLI treatment include Aastrom Biosciences, Arteriocyte and Biomet.

Among the top advantages of Juventas CLI therapy is its simplicity and cost-effectiveness, Aras said. Patients can be injected with the companys therapeutic in an easy procedure at a physician office, and the approach doesnt require bone marrow aspiration to obtain patients own stem cells or complex cell processing as some competing therapeutics do.

Juventas also has a phase 2 trial underway to investigate its therapy with heart failure patients.

The company is expected to shortly announce a series B round of investment, which includes the funding from Takeda, that totals around $20 million or $25 million.

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Regenerative medicine company begins enrollment in critical limb ischemia trial

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Philippine Daily Inquirer

Former President and current Pampanga Rep. Gloria Macapagal-Arroyo, who was suffering from a mineral deficiency in her bones arising from two corrective surgeries last September, wanted to seek alternative stem cell therapy abroad.

However, she was barred from leaving the country last November after Justice Secretary Leila de Lima refused to honor the temporary restraining order issued by the high court on the inclusion of Arroyo and her husband Jose Miguel Mike Arroyo in the immigration bureaus watch list.

In the wake of Arroyos supposed plan to try the radical technology at stem cell centers abroad to cure what her doctors here described as a rare bone disease, a province mate and a colleague of the former President filed a bill to put up a stem cell center in the country.

Pampanga Rep. Carmelo F. Lazatin, a member of the minority bloc in Congress, has filed House Bill No. 5287 mandating the establishment of a research facility to explore the benefits of stem cell technology as a potential cure for incurable diseases.

Blank cells

Stem cells, the foundation of every organ, tissue and cell within the human body, are like blank cells that do not yet have a specific physiological function, according to Harvard Stem Cell Institute (HSCI).

But when proper conditions in the body or in the laboratory occur, stem cells develop into specialized tissues and organs, HSCI explains in its website, adding that there are two sources of stem cells used in research: the adult stem cells and embryonic stem cells.

Adult stem cells are found in differentiated tissues and organs throughout the body while embryonic stem cells are obtained from the inner cell mass of a blastocyst, the ball of cells formed when the fertilized egg or zygote divides and forms two cells, then again to form four and so on, HSCI said.

In 2008, the Vatican issued a sweeping document on bioethical issues titled Dignitas Personae or The Dignity of the Person, taking into account recent developments in biomedical technology and reinforcing the Churchs opposition to embryonic stem cell research, in vitro fertilization, human cloning and genetic testing on embryos before implantation.

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In The Know: Stem cell therapy

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11-05-2012 14:16 Stem cells are the body's repair cells. They have the ability to divide and differentiate into many different types of cells based on where they are needed throughout the body. Stem cells can divide and turn into tissues such as skin, fat, muscle, bone, cartilage, and nerve to name a few. With this capability, we can use them as a treatment for joint injuries, ligament and tendon damage, and fractured bones. Using MediVet America's Stem Cell Therapy, we have seen positive clinical improvement in 95% of the arthritic cases performed nationwide. Some owners have even reported seeing a difference in as little as a week!

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Stem Cell Therapy Exclusively at Gandy Animal Hospital - Tampa, FL - Video

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Philippine Daily Inquirer

Former President and current Pampanga Rep. Gloria Macapagal-Arroyo, who was suffering from a mineral deficiency in her bones arising from two corrective surgeries last September, wanted to seek alternative stem cell therapy abroad.

However, she was barred from leaving the country last November after Justice Secretary Leila de Lima refused to honor the temporary restraining order issued by the high court on the inclusion of Arroyo and her husband Jose Miguel Mike Arroyo in the immigration bureaus watch list.

In the wake of Arroyos supposed plan to try the radical technology at stem cell centers abroad to cure what her doctors here described as a rare bone disease, a province mate and a colleague of the former President filed a bill to put up a stem cell center in the country.

Pampanga Rep. Carmelo F. Lazatin, a member of the minority bloc in Congress, has filed House Bill No. 5287 mandating the establishment of a research facility to explore the benefits of stem cell technology as a potential cure for incurable diseases.

Blank cells

Stem cells, the foundation of every organ, tissue and cell within the human body, are like blank cells that do not yet have a specific physiological function, according to Harvard Stem Cell Institute (HSCI).

But when proper conditions in the body or in the laboratory occur, stem cells develop into specialized tissues and organs, HSCI explains in its website, adding that there are two sources of stem cells used in research: the adult stem cells and embryonic stem cells.

Adult stem cells are found in differentiated tissues and organs throughout the body while embryonic stem cells are obtained from the inner cell mass of a blastocyst, the ball of cells formed when the fertilized egg or zygote divides and forms two cells, then again to form four and so on, HSCI said.

In 2008, the Vatican issued a sweeping document on bioethical issues titled Dignitas Personae or The Dignity of the Person, taking into account recent developments in biomedical technology and reinforcing the Churchs opposition to embryonic stem cell research, in vitro fertilization, human cloning and genetic testing on embryos before implantation.

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In The Know: Stem cell therapy

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CAMBRIDGE, England--(BUSINESS WIRE)--

Lab21, the global specialist in personalized medicine and clinical diagnostics, is pleased to announce that routine analysis of clinical samples has begun from Lab21 Inc.s new CLIA laboratory in Greenville, South Carolina.

The first assays in the test menu include a new Human Papillomavirus (HPV) High Risk and HPV 16 and 18 Genotyping Service. Using the Roche COBAS 4800 HPV Genotyping test, Lab21 can identify high risk patients and differentiate those patients with HPV 16 and HPV 18 Genotypes. The Lab21 service launches concurrently with new guidelines for the prevention and early detection of cervical cancer which were recently issued by the American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP).

Michael Bolick, President, Lab21 Inc said Over recent months we have grown the Greenville team and worked closely with local clinicians to prioritize the menu of tests required by local hospitals. The final validation of these assays and the receipt of our first patient samples are the culmination of Lab21s strong team work internationally. Our colleagues from the UK have developed best practices in molecular diagnostic testing that we have transferred, along with key individuals, into our US operations.

Lab21 Inc is focused on the provision of molecular diagnostic testing services in oncology and infectious disease. Launch of these services will include KRAS, EGFR and BRAF mutation analysis, HIV viral resistance and tropism and viral load assays. This follows Lab21s recent launch of the Clinical Genomics Center at ITOR, a hospital based cancer research organization located in Greenville, South Carolina. It is planned that through the partnership with ITOR, Lab21 will develop new companion diagnostic assays required to accompany new drug therapies.

Ken Morgan, Vice President Operations, Lab21 Inc said We welcome our new Laboratory Manager, Susan Foster, and Clinical Sequencing Group Leader, Jeremy Stuart to Lab21 Inc who are two very experienced clinical testing professionals from market leading companies. During the next 12 months we intend to grow our core team in Greenville rapidly as we add new test menu and launch our own companion diagnostic assays.

END

About Lab21

Lab21 is a global leader in personalized healthcare. It provides diagnostic products and services and supports blood bank screening, medical diagnostics and drug discovery. Lab21 customers include international healthcare providers, pharmaceutical and diagnostic companies. The Products division of Lab21 manufactures immunodiagnostic kits and reagents that are distributed internationally and is focused on infectious diseases for the blood-banking and clinical markets. Our clinical services operations have a growing test portfolio providing companion diagnostics and high technology molecular assays. Lab21's corporate offices are based in Cambridge, UK and Greenville, South Carolina, with a GMP manufacturing site in Cambridge and other manufacturing facilities in Newmarket, Camberley, Manchester and Bridport. Website: http://www.lab21.com

About the new guidelines for the prevention and early detection of cervical cancer

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Lab21 Unveils New Molecular Analysis Services at Greenville Site

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Public release date: 11-May-2012 [ | E-mail | Share ]

Contact: Bryan Alary bryan.alary@ualberta.ca 780-492-0436 University of Alberta

(Edmonton) People with spinal cord injuries and reduced mobility now have access to specialized exercise equipment in an inclusive community setting, thanks to a partnership between the University of Alberta and the Spinal Cord Injury Treatment Centre (Northern Alberta) Society.

Two new functional electrical stimulation (FES) rehabilitation therapy machines are now available at the Saville Community Sports Centre, operated by the Faculty of Physical Education and Recreation at the U of A. FES is a form of exercise for people with spinal cord injuries, stroke and other neuromuscular disorders that involves sending electrical currents to paralyzed or weakened muscles so they contract to restore some degree of functional movement.

The new FES equipment and staffing support was provided by the Spinal Cord Injury Treatment Centre (Northern Alberta) Society. One of the machines, called the RT 200 elliptical, allows users to exercise their arms and legs at the same timea rarity among such equipment in Canada.

"Through the incredible support of partners like the Spinal Cord Injury Treatment Centre (Northern Alberta) Society, the University of Alberta has established itself as a leader in adapted physical activity rehabilitation in Canada," said Karen Slater, associate director of the Steadward Centre for Personal & Physical Achievement, which runs the community FES transition program in collaboration with the society and Saville Community Sports Centre.

"This partnership allows us to bring in technology that no one else is using in a community setting in Canada. That means we can provide a better service to our users so they can live healthier, happier, more independent lives."

The value of independence and inclusivity cannot be underestimated given that many FES machines are located in hospitals and rehabilitation settings, said Louise Miller, president of the Spinal Cord Injury Treatment Centre (Northern Alberta) Society.

"This allows people to go to a fitness centre where everybody else is working out. You can go and exercise next to your friend or family member. You can go when you want," said Miller.

Miller co-founded the not-for-profit society in 1987, a few years after life-saving surgery left her with paraplegia. A former nurse, she felt more could be done for people with spinal injuries and has spent the last 25 years working to create opportunities for people to maintain their quality of life.

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Partnership provides inclusive workout

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On a warm summer night in 1978 , Robb Dunfield and two friends climbed up into a house under construction near Jericho Beach to get a better view of the pillowy tall ships floating in the harbour.

They stepped out onto a balcony where the railing had not yet been built. Instead, there was merely a board tapped into place with a nail at either end.

It gave way quickly and Dunfield, then an athletic 19-year-old with a zest for adventure, plunged 30 feet into the darkness. Down, down he went, crashing into an abyss. In those few moments, his life changed irrevocably.

A church minister who was out walking his dog found him and called an ambulance.

When Dunfield regained consciousness several days later in the hospital, he remembers apologizing to his parents for all the trips they were having to make to his bedside.

In those first days, his life hovered in the balance.

He was under a "do not resuscitate" order. He went into cardiac arrest. That same church minister, who happened to be a friend of his family, gave him the last rites.

Slowly, reality sank in. Having broken his back at the second vertebra from the top of the spinal cord, he would never use his arms or legs again.

At first, he could breathe on his own and had some movement in his shoulder. But within a couple of days, he lost that, too. He was told he likely wouldn't live beyond another two years.

Thirty-four years later, Dunfield, at 52, sits in a wheelchair, his body completely immobilized from the neck down.

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Living with a spinal cord injury

Recommendation and review posted by sam

. Approximately 86,000 Canadians are living with a spinal cord injury, with 4,300 new cases each year.

. One in three people in Canada will be disabled for three or more months before the age of 65.

. Canadians with a spinal cord injury are re-hospitalized 2.6 times more often than the aver-age Canadian. They also require three times more contact with a physician and 30 times more hours of home care service.

. People with a spinal cord injury have a life expectancy of 15 to 30 fewer years than the average Canadian.

. The financial care requirements over a lifetime for some-one with a spinal cord injury can range from $1.6 million to $3 million, depending on the level of paralysis.

. The economic cost of traumatic spinal cord injury is estimated at $3.6 billion a year in Canada.

. More than 60 per cent of people living with a spinal cord injury are unemployed.

. Rick Hansen's original tour 25 years ago raised $26 mil-lion, which has been leveraged into $245 million in direct investments.

. The Rick Hansen Foundation supports numerous projects and programs, such as the Blusson Spinal Cord Centre, and has funded organizations like the Canadian Paraplegic Association and the Neil Squire Foundation, which offer vital assistance to those living with spinal cord injuries and to their families.

. The foundation has also worked with schools, municipalities and community groups to create 47 accessible play-grounds in B.C., while the Rick Hansen School Program provides teaching tools to more than 1,000 Canadian schools.

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Spinal cord injuries in Canada

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Takeda Pharmaceuticals is a strategic investor in regenerative medicine company Juventas Therapeutics upcoming series B round of funding.

Juventas CEO Rahul Aras discussed the investment during a panel at a meeting of the Ohio Venture Association on Friday.

If you think venture capital due diligence is difficult Aras joked, I think [Takeda] called my mother.

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Aras has previously said that the Cleveland-based Juventas was targeting about $25 million in the round.

Juventas is a Cleveland Clinic spinoff and is based on technology pioneered by former Clinic cardiologist Marc Penn.

The companys technology, JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. Its based on Stromal Cell-Derived Factor-1 (SDF-1), a naturally produced molecule that attempts to repair the heart immediately following a heart attack.

The company is investigating JVS-100 for the treatment of patients who suffer from heart failure and critical limb ischemia.

One panelist asked Aras whether Takedas investment means its likely to be Juventas eventual acquirer. I dont assume anything about an exit, Aras said. I just focus on developing the company and figure someone will eventually want to buy us.

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Takeda to invest in regenerative medicine startup Juventas’ next round

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Pluristem Therapeutics Ltd. (Nasdaq:PSTI; DAX: PJT: PLTR)has announced that a seven year-old girl suffering from an aplastic bone marrow whose condition was rapidly deteriorating has seen a reversal of her condition. The improvement came due to a significant increase in her red cells, white cells and platelets following the intramuscular injection of Pluristem's PLacental eXpanded (PLX) cells. Aplastic bone marrow is a disease where the patient has no blood-forming hematopoietic stem cells in the bone marrow.

Hadassah Medical Center Bone Marrow Transplantation, Cell Therapy and Transplantation Research Center director Prof. Reuven Or said, "With her body rejecting all possible treatment, and with no other options, we finally turned to Pluristem's PLX cells, which literally saved her life. The results of this unique case indicate that PLX cells may be effective in treating other diseases that affect the bone marrow."

The patient has been hospitalized at the Hadassah Hebrew University Medical Center in Jerusalem since August 2011. Her aplastic bone marrow had been refractory to treatment. So she underwent allogeneic stem cell transplantation from a matched unrelated donor. The first transplant was unsuccessful and the patient remained with bone marrow failure. The patient underwent a second allogeneic stem cell transplantation from a second donor. The bone marrow function was very poor and the patient suffered from recurrent infections.

Two months after the patient's second bone marrow transplant, the child received PLX cells intramuscularly in two doses about one week apart. Some 10 days after the last administration of PLX cells, the patient's hematological parameters began to significantly increase, an effect that has persisted to date. The patient's general clinical status has also improved. Subsequent analysis has indicated that the PLX cells worked by stimulating the recovery of the hematopoietic stem cells contained in the second bone marrow transplant that she had received over two months earlier. Finally, after nine months of hospitalization, the child will be discharged from the hospital.

Pluristem chairman and CEO Zami Alberman said, "Pluristem is extremely happy that our PLX cells have helped this little girl. Remarkably, these beneficial effects were seen in the patient after our PLX cells were administered intramuscularly and correlate with the positive effects on the bone marrow when we administered our PLX cells intramuscularly (IM) in animals exposed to toxic levels of radiation. Pluristem now has several data points to indicate that our PLX cells may work for systemic diseases when given locally, away from the target organ, and without a need to give cells intravenously."

In February 2012, Pluristem announced the results of animal studies suggesting PLX cells can be potentially effective in treating the life threatening hematopoietic complications associated with Acute Radiation Syndrome (ARS). In these experiments, animals given PLX cells IM up to 24 hours post irradiation demonstrated a recovery of their red cells, white cells, platelets and bone marrow to almost normal levels. It was that announcement, and the significant deterioration of the patient following two bone marrow transplants, that led Prof. Or to contact Pluristem about the possible compassionate use of PLX cells to treat his young patient.

Pluristem recently received US FDA clearance to begin a Phase II clinical trial using the company's proprietary PLX-PAD cell product candidate intramuscularly for the treatment of Intermittent Claudication (IC), a subset of peripheral artery disease (PAD).

Published by Globes, Israel business news - http://www.globes-online.com - on May 9, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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Pluristem stem cells save girl's life

Recommendation and review posted by Bethany Smith

(CBS News) Patients with brain cancer may face devastating side effects from chemotherapy, but a new study offers a possible solution: stem cells.

Yearly dental X-rays raise brain tumor risk, study finds

Memorial Hermann hospital in Houston to live tweet brain tumor surgery

The stem cells form a shield of sorts against the toxic side effects from chemo, according to the researchers behind the study. It was a small trial that involved only three patients with glioblastoma, the most aggressive and common form of a malignant brain tumor that's usually fatal.

Two of the patients survived longer than predicted with help from the stem cell treatment - an average of 22 months - and a third man from Alaska remains alive today with no disease progression almost three years following treatment.

How does it work?

Many patients with the deadly form of brain cancer possess a gene called MGMT. The MGMT gene is typically turned on and counters the effects from some chemotherapy agents, such as temozolomide, rendering them less effective. As such, people with such a gene often have a particularly poor prognosis.

A drug called benzylguanine can block the MGMT gene, thus making tumors more receptive to chemotherapy, but the combination of the drug and chemo are often too toxic for healthy bone marrow cells.

That's where the new stem cell treatment comes in. By combining bone marrow stem cells with a modified version of MGMT in the form of the new treatment, patients' cells were protected from the toxic effects of the cancer drugs and chemotherapy while keeping the tumor cells targeted.

"This therapy is analogous to firing at both tumor cells and bone marrow cells, but giving the bone marrow cells protective shields while the tumor cells are unshielded," study author Dr. Jennifer Adair, a researcher at the Fred Hutchinson Cancer Research Center in Seattle, said in a news release.

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Stem cells boost brain tumor treatments for some patients, study finds

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LAS VEGAS, May 10, 2012 /PRNewswire/ -- An investigational therapyderived from a patient's own bone marrow stem cells improves heart function in some patients with progressive heart failure due to dilated cardiomyopathy (DCM), according to the results of a Phase 2a study presented today as a late-breaking clinical trial at the SCAI 2012 Scientific Sessions.

Ixmyelocel-T is developed by culturing a patient's bone marrow for 12 days to increase the numbers of immune cells including macrophages and monocytes, as well as mesenchymal cells, stem cells that can differentiate into several different cell types. The resulting cell treatment is then injected into the patient's heart muscles to encourage growth of new tissue and improve inflammation.

"An increasing number of patients have progressive heart failure due to dilated cardiomyopathy, even after treatment with drug therapy and surgical intervention," said Timothy Henry, MD, FSCAI, director of research and an interventional cardiologist at the Minneapolis Heart Institute at Abbott Northwestern Hospital, and the study's principal investigator. "In this study, patients treated with ixmyelocel-T showed repair in damaged heart muscle and some reversal in heart failure symptoms."

The trial included 22 ischemic (IDCM) and non-ischemic (NIDCM) patients with a New York Heart Association (NYHA) heart failure class of III or IV, or moderate to severe heart failure, and a left ventricular ejection fraction of 30 percent or less, which is a measure of how much blood leaves the heart with each pump. Patients were randomized to receive an injection of the treatment into their heart muscles or to a control group, and were followed at 3, 6 and 12 months.

After 12 months, no procedural complications and no difference in adverse events were reported among patients who received the treatment and the control group. IDCM patients who received the cell treatment had a lower mean number of major adverse clinical events (0.33 compared to 1.67 in the control group). IDCM patients who received the treatment were more likely to see improvement in NYHA class, six-minute walking distance and ejection fraction, compared to NIDCM patients who received the treatment and those in the control group.

"Treatment with ixmyelocel-T was well-tolerated and patients who received the cell therapy showed improved symptoms after one year," said Dr. Henry. "The results provide a strong basis for a larger clinical trial of this treatment in patients with dilated cardiomyopathy."

The study was sponsored by Aastrom Biosciences.

Dr. Henry will present "Safety and Efficacy ofIxmyelocel-T, An Expanded Patient-Specific Mixed Cell Therapy, in Dilated Cardiomyopathy" on Thursday, May 10, 2012, in the Late-Breaking Clinical Trials Session beginning at 12:00 p.m. (Pacific Time).

About SCAI

Headquartered in Washington, D.C., the Society for Cardiovascular Angiography and Interventions is a 4,000-member professional organization representing invasive and interventional cardiologists in approximately 70 nations. SCAI's mission is to promote excellence in invasive and interventional cardiovascular medicine through physician education and representation, and advancement of quality standards to enhance patient care. SCAI's patient education program, Seconds Count, offers comprehensive information about cardiovascular disease. For more information about SCAI and Seconds Count, visit http://www.scai.org or http://www.SecondsCount.org.

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Treatment with Ixmyelocel-T Shown to Improve Outcomes in Heart Failure Patients

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A stem cell breakthrough at UCLA could mark a big step for a biopharmaceutical company to use its proprietary technology to forge partnerships with pharmaceutical companies and other research institutions.

Fibrocell Sciences technology isolates, purifies and multiplies a patients fibroblast cells, connective skin cells that make collagen. In a research collaboration with the company, UCLA used the technology to isolate, identify and increase the number of different skin cell types, which lead to two rare adult stem cell-like subpopulations being identified in adult human skin SSEA3-expressing regeneration-associated cells associated with skin regeneration after injuries and mesenchymal adult stem cells.

The findings could have broad applications for personalized medicine. Currently, adult stem cells are derived from adipose tissue and bone marrow. Using mesenchymal stem cells would be less invasive and could be more efficient. Mesenchymal stem cells are being used in research to develop osteoblasts, or bone cells; chondrocytes, or cartilage cells; and adipocytes, or fat cells.

David Pernock, the chairman and CEO of Fibrocell, said the move could mark a significant step in the companys growth.

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Stem cell collaboration could set stage for company’s growth

Recommendation and review posted by Bethany Smith

CARLSBAD, Calif.--(BUSINESS WIRE)--

International Stem Cell Corporation (OTCBB: ISCO.OB - News) http://www.internationalstemcell.com today announced that the Company has developed new technologies to commercialize the use of human parthenogenetic stem cells (hpSC) to treat human diseases. The methods announced today are capable of producing populations of stem cells and their therapeutically valuable derivatives not only to a higher level of purity but also at a cost that is approximately several times lower than previously reported techniques.

ISCOs research team has developed a new method to derive high-purity populations of neural stem cells (NSC) from hpSC and further differentiate them into dopaminergic neurons. This method is capable of generating sufficient quantities of neuronal cells for ISCOs pre-clinical and clinical studies and is highly efficient as it requires substantially less time and labor in addition to using fewer costly materials than traditional methods. ISCOs technologies make possible the creation of billions of neuronal cells necessary for conducting such studies from a small batch of stem cells.

ISCO has also announced today that it has developed a new high-throughput cell culture method for growing human parthenogenetic stem cells (hpSC) in large quantities. This new technique is easily scalable and can produce the quantities of cGMP grade hpSC necessary for commercial and therapeutic applications.

One of the most challenging issues in commercializing stem cell based treatments is creating high-purity populations of stem cell derivatives at a reasonable cost. I believe the new methods we have developed solve this important problem and help position us for future clinical studies, says Dr. Ruslan Semechkin, Vice President, R&D.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology, and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com or follow us on Twitter @intlstemcell.

To receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0.

Forward-looking Statements

Statements pertaining to anticipated developments, the potential benefits of research programs and new manufacturing technologies, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and technologies regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

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International Stem Cell Corporation Announces New Stem Cell Manufacturing Technologies to Support its Therapeutic ...

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THE WOODLANDS, Texas--(BUSINESS WIRE)--

Opexa Therapeutics, Inc. (NASDAQ:OPXA - News), a company developing Tovaxin, a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the quarter ended March 31, 2012 and provided an update on recent corporate developments.

Corporate development highlights include:

We are progressing favorably in the planning and preparations for a clinical trial in Secondary Progressive MS patients, commented Neil K. Warma, President and Chief Executive Officer of Opexa. The clinical trial protocol was submitted to the FDA for final review and we received no additional comments from them. This is a key milestone for us, providing us with the necessary regulatory positioning to advance with the trial preparations and discussions with potential trial sites. Operationally, we believe we remain on track to initiate the trial in the coming months as the team continues to work diligently to finalize preparations. In order to initiate the trial, we will need to secure additional financing, either through a potential partnership or additional capital raise, and this continues to be an important focus for us.

The meeting we recently held with clinical trial investigators at the annual American Academy of Neurology conference was well attended and included some of the most influential MS opinion leaders participating in the discussions related to our clinical trial design and enrollment criteria. We are anticipating strong enrollment once we are able to begin the trial, driven by the support of the clinicians and a strong desire from patients to participate. SPMS is understood to be a very serious medical condition coupled with the fact that patients have limited treatment options. We hope that Tovaxin can eventually develop into a treatment of choice, not only for SPMS but for all MS patients.

As of the end of the first quarter, our cash and cash equivalents totaled approximately $4.7million and our monthly burn rate for the quarter was approximately $810,000, inclusive of increased cash expenditures to support preparations for the initiation of the planned Phase IIb clinical study in North America.

First Quarter Financial Results

Opexa reported no commercial revenues in the three months ended March 31, 2012 or in the comparable prior-year period.

Research and development expenses were $1,490,097 for the three months ended March 31, 2012, compared with $685,161 for the three months ended March 31, 2011. The increase in expenses was primarily related to an increase in the procurement and use of laboratory reagents and supplies, and increases in professional service fees, employee personnel costs, facility costs and non-cash stock compensation expense.

General and administrative expenses for the three months ended March 31, 2012 were $816,196, compared with $592,058 for the three months ended March 31, 2011. The increase in expense is due to increases in business development activities, legal expenses, employee compensation expense and non-cash stock compensation expense.

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Opexa Therapeutics Reports First Quarter 2012 Financial Results and Provides Corporate Update

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