Archive for the ‘Regenerative Medicine’ Category

(PRWEB) July 11, 2012

"Post fusion pain is treated with cell therapy now at the center for regenerative medicine," according to Doctor Farshchian, the medical director for the center for regenerative medicine.

The joint at the base of the big toe is called the metatarophalangeal joint, or MTP joint. This is the junction of small bone of the big toe and the long bone of the forefoot.

This joint is essential to the biomechanics of our feet, receiving much stress and prone to arthritis by itself. Pain around the base of the big toe is a common symptom of arthritis around this area.

This pain is exacerbated by activity. After the joint is fused by itself, the toe may not touch the ground, which may cause slight instability or imbalance when the patient walks.

The Center for Regenerative Medicine in Miami, Florida concentrates on helping arthritic and injured people to get back to a functional level of life and their activities using non-surgical techniques and Orthopedic medicine. The center's expertise is in treatment of conditions of spine, knees , shoulders , and other cartilage damages. They have developed non-surgical and rehabilitation techniques focused on treatment and management of joint pain. Theirr team includes health professionals organized around a central theme. Their website is http://www.arthritisusa.net

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Post Fusion Pain is Treated with Cell Therapy Now at the Center for Regenerative Medicine

Public release date: 6-Jul-2012 [ | E-mail | Share ]

Contact: Brianna Deane bdeane@dentistry.ucla.edu 310-206-0835 University of California - Los Angeles

The ability to control whether certain stem cells ultimately become bone cells holds great promise for regenerative medicine and potential therapies aimed at treating metabolic bone diseases.

Now, UCLA School of Dentistry professor and leading cancer scientist Dr. Cun-Yu Wang and his research team have made a significant breakthrough in that direction. The scientists have discovered two key epigenetic regulating genes that govern the cell-fate determination of human bone marrow stem cells.

Wang's new research is featured on the cover of the July 6 issue of Cell Stem Cell, the affiliated journal of the International Society for Stem Cell Research.

The groundbreaking study grew out of Wang's desire to better understand the epigenetic regulation of stem cell differentiation, in which the structure of genes is modified while the sequence of the DNA is not. He and his team found that KDM4B and KDM6B, two gene-activating enzymes, can promote stem cells' differentiation into bone cells by removing methyl markers from histone proteins. This process occurs through the activation of certain genes favoring a commitment to one lineage and the concurrent deactivation of genes favoring other lineages.

The findings imply that chemical manipulation of these gene-activating enzymes may allow stem cells to differentiate specifically into bone cells, while inhibiting their differentiation into fat cells. The group's research could pave the way toward identifying potential therapeutic targets for stem cellmediated regenerative medicine, as well as the treatment of bone disorders like osteoporosis, the most common type of metabolic bone disease.

"Through our recent discoveries on the lineage decisions of human bone marrow stem cells, we may be more effective in utilizing these stem cells for regenerative medicine for bone diseases such as osteoporosis, as well as for bone reconstruction," Wang said. "However, while we know certain genes must be turned on in order for the cells to become bone-forming cells, as opposed to fat cells, we have only a few clues as to how those genes are switched on."

The research group, through its study of aging mice, found that the two enzymes KDM4B and KDM6B could specifically activate genes that promote stem cell differentiation toward bone, while blocking the route toward fat.

"Interestingly, in our aged mice, as well as osteoporotic mice, we observed a higher amount of silencing histone methyl groups which were normally removed by the enzymes KDM4B and KDM6B in young and healthier mice," Wang said. "And since these enzymes can be easily modified chemically, they may become potential therapeutic targets in tissue regeneration and treatment for osteoporosis."

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UCLA researcher discovers epigenetic links in cell-fate decisions of adult stem cells

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the companys three ongoing clinical trials, has authorized the company to move forward with enrollment and treatment of additional patients in its clinical trial for dry age-related macular degeneration (dry AMD). ACT will proceed with patient screening and enrollment for the second cohort, who, in keeping with trial protocol, will be injected with 100,000 retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs), as compared with the 50,000-cell dose used in the first cohort.

DSMB authorization to move to the higher dosage of cells in our clinical trial for dry AMD represents a significant milestone for our clinical programs, commented Gary Rabin, chairman and CEO of ACT. Our RPE program is now advancing rapidly, as we are now screening at multiple ophthalmological centers for the fourth surgery in both our dry AMD trial and our U.S. SMD trial, with our E.U. SMD trial, which was initiated much later, not far behind.

The trial is a prospective, open-label study, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD at 12 months, the studys primary endpoint. The three procedures comprising the first cohort of patients were all conducted at University of California at Los Angeles (UCLA), by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute. It was announced in May that Mass Eye and Ear is an additional site for the trial.

Mr. Rabin added, Dry AMD represents one of the largest unmet ophthalmological needs in the world, with a potential market of $25 billion in the U.S. and Europe, alone, and this DSMB approval is a big step toward being able to potentially address that massive medical need.

ACT is conducting a total of three clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format. Treatment of the final patient of the first cohort in the companys dry AMD trial was announced on April 20. On June 29, the second SMD patient enrolled in the Companys E.U. clinical trial was treated at Moorfields Eye Hospital in London, U.K., and on April 24 the company announced DSMB approval to treat the second patient cohort in its U.S. SMD trial.

Further information about patient eligibility for ACTs dry AMD study and the companys concurrent SMD studies in the U.S. and E.U. is available at http://www.clinicaltrials.gov, with the following Identifiers: NCT01344993 (dry AMD), NCT01345006 (U.S. SMD), and NCT01469832 (E.U. SMD).

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

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ACT Secures Approval to Proceed with Increased RPE Dosage for Patients in Clinical Trial for Dry AMD

ScienceDaily (July 9, 2012) The ability to control whether certain stem cells ultimately become bone cells holds great promise for regenerative medicine and potential therapies aimed at treating metabolic bone diseases.

Now, UCLA School of Dentistry professor and leading cancer scientist Dr. Cun-Yu Wang and his research team have made a significant breakthrough in that direction. The scientists have discovered two key epigenetic regulating genes that govern the cell-fate determination of human bone marrow stem cells.

Wang's new research is featured on the cover of the July 6 issue of Cell Stem Cell, the affiliated journal of the International Society for Stem Cell Research.

The groundbreaking study grew out of Wang's desire to better understand the epigenetic regulation of stem cell differentiation, in which the structure of genes is modified while the sequence of the DNA is not. He and his team found that KDM4B and KDM6B, two gene-activating enzymes, can promote stem cells' differentiation into bone cells by removing methyl markers from histone proteins. This process occurs through the activation of certain genes favoring a commitment to one lineage and the concurrent deactivation of genes favoring other lineages.

The findings imply that chemical manipulation of these gene-activating enzymes may allow stem cells to differentiate specifically into bone cells, while inhibiting their differentiation into fat cells. The group's research could pave the way toward identifying potential therapeutic targets for stem cell-mediated regenerative medicine, as well as the treatment of bone disorders like osteoporosis, the most common type of metabolic bone disease.

"Through our recent discoveries on the lineage decisions of human bone marrow stem cells, we may be more effective in utilizing these stem cells for regenerative medicine for bone diseases such as osteoporosis, as well as for bone reconstruction," Wang said. "However, while we know certain genes must be turned on in order for the cells to become bone-forming cells, as opposed to fat cells, we have only a few clues as to how those genes are switched on."

The research group, through its study of aging mice, found that the two enzymes KDM4B and KDM6B could specifically activate genes that promote stem cell differentiation toward bone, while blocking the route toward fat.

"Interestingly, in our aged mice, as well as osteoporotic mice, we observed a higher amount of silencing histone methyl groups which were normally removed by the enzymes KDM4B and KDM6B in young and healthier mice," Wang said. "And since these enzymes can be easily modified chemically, they may become potential therapeutic targets in tissue regeneration and treatment for osteoporosis."

"The discovery that Dr. Wang and his team have made has considerable implications for craniofacial bone regeneration and treatment for osteoporosis," said Dr. No-Hee Park, dean of the UCLA School of Dentistry. "As a large portion of our population reaches an age where osteoporosis and gum disease could be major health problems, advancements in aging-related treatment are very valuable."

Professor Wang holds the No-Hee Park Endowed Chair in Dentistry at the UCLA School of Dentistry, where he is also chair of the division of oral biology and medicine and the associate dean for graduate studies.

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Discovery of epigenetic links in cell-fate decisions of adult stem cells paves way for new osteoporosis treatments

(PRWEB) July 08, 2012

"Trauma to Ankle joint can cause arthritis," according to A.J. Farshchian MD, a regenerative medicine practitioner at The Center for regenerative medicine.

The ankle joint is known as a diarthrodial joint. Of all the joints in the body it is probably the joint most resistant to a degenerative condition. This immunity to arthrosis is primarily associated to the joints liberal distribution of forces throughout a series of interlinked compartments. The ankle joint and accompanying foot joints support the body as would a tri-pod supporting a camera. The supporting surfaces of the ankle and foot have a tri-pod structure to its form. The ankle joint represents the lateral (or outside) support column of the tri-pod supporting form. The heel bone represents the posterior column of the support form. The mid-foot and the forefoot represent the anterior support column. This tri-pod support form is not static but dynamic in its function. As the stresses change and the strains converge on points along the weight-bearing surfaces of the ankle foot adjustments are made to maintain the center of gravity within the supporting tri-pod columns.

Rarely would age related degenerative changes be seen in the ankle and foot. When degenerative changes develop in the ankle or the other support columns it is normally preceded by a history of trauma. This trauma is usually a fracture in one of the supporting hard tissues. Serious ligamental injury can also affect a degenerative condition. Following a ligamental or fracture injuries an uncoupling of the local traumatic region occurs. This uncoupling reduces the normal cellular metabolic response to weight-bearing forces of the local traumatized area. The traumatized area is isolated from the nutritious effect of tolerable strains and exposed to harmful stresses. These harmful stresses initiate cellular destruction which later becomes a degenerative condition.

The Center for Regenerative Medicine in Miami, Florida concentrates on helping arthritic and injured people to get back to a functional level of life and their activities using non-surgical techniques and Orthopedic medicine. The center's expertise is in treatment of conditions of spine, knees, shoulders and other cartilage damages. They have developed non-surgical and rehabilitation techniques focused on treatment and management of joint pain. Their team includes health professionals organized around a central theme. Their website is http://www.arthritisusa.net.

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Trauma to Ankle joint can cause arthritis

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the second patient in its Phase 1/2 clinical trial for Stargardts macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Friday, June 29 at Moorfields Eye Hospital in London, the same site as the first patient treatment in January, by a team of surgeons led by Professor James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies at University College London. The procedure was successfully performed without any complications. ACT and Moorfields Eye Hospital recently received clearance from the Data and Safety Monitoring Board (DSMB) to treat the final two patients in the first cohort of this clinical trial.

We are very pleased to continue our forward momentum with both our U.S. trials and our European trial, commented Gary Rabin, chairman and CEO. It was less than a month ago that we received DSMB approval to treat the second and third patients in our E.U. trial, and it is very gratifying to have already completed dosing of the second. It is a pleasure to be working with Professor Bainbridge and the rest of his team at Moorfields Eye Hospital, and we continue to be encouraged by the steady progress of the trial thus far.

The Phase 1/2 trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the studys primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format. It is similar in design to the U.S. trial for SMD that was initiated in July 2011.

The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has officially designated ACT's human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells as an orphan medicinal product for the treatment of Stargardt's Macular Dystrophy (SMD).

More information on the status of the companys clinical trials will be posted today on Mr. Rabins Chairmans blog.

About Stargardts Disease Stargardts disease or Stargardts Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

About Advanced Cell Technology, Inc. Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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ACT Announces Second Patient with Stargardt’s Disease Treated in EU Clinical Trial

SAN DIEGO, CA--(Marketwire -07/02/12)- DPR Construction (DPR) has been awarded a multi-million dollar contract to manage the construction of a regenerative medicine campus on behalf of Advanced BioHealing and Shire plc, the global specialty biopharmaceutical company, with real estate partner BioMed Realty Trust, Inc. and designers Ferguson Pape Baldwin Architects.

The new campus in Sorrento Mesa will expand the operational footprint of Shire's regenerative medicine business, Advanced BioHealing, Inc., and create the increased capacity it needs to meet future demand for its lead product, DERMAGRAFT, while offering additional space and infrastructure to manufacture new regenerative medicine products.

"This project will generate hundreds of jobs, including much needed construction jobs, during the build out over the new two years, and we are honored to be a part of it," said Jay Leopold, Regional Manager of DPR's San Diego office. "We look forward to working with the project partners to implement our High Performance Team strategies and create a model facility for attracting more biomedical business here in San Diego."

Phase I of the site development will be in excess of 150,000 square feet and will house the company's manufacturing and associated support operations, commercial operations, corporate, and administrative functions. Preconstruction and design is underway with construction scheduled to begin in 2013. Initial occupancy is targeted for 2014.

About DPR ConstructionDPR Construction, named by FORTUNE as #13 of the "100 Best Companies To Work For," is a forward-thinking national general contractor and construction manager specializing in life science, healthcare, corporate office, advanced technology and higher education projects. A privately held, employee-owned company, DPR has grown to more than $1 billion in annual revenue, making it one of the largest general contractors in the nation. Locally, DPR is a perennial Top 5 general contractor with annual revenue averaging well over $200 million in projects ranging from $5k to $600M. DPR's San Diego office is located at 5010 Shoreham Place, San Diego, CA 92122. For more information about DPR, visit: http://www.dpr.com.

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DPR Construction Awarded Multi-Million Dollar Contract to Manage Build Out of Shire Advance BioHealing Campus in ...

(PRWEB) June 30, 2012

Regenerative medicine may help with Avascular Necrosis, according to A. J. Farshchian MD an Orthopedic Regenerative physician at the Center for Regenerative Medicine.

Avascular necrosis can be quite devastating, and lead to total loss of the ankle joint with arthritis, deformity and pain. Loss of blood supply to the bone can be caused by an injury (trauma-related avascular necrosis) When a joint is injured, as in a fracture or dislocation, the blood vessels may be damaged. This can interfere with the blood circulation to the bone and lead to trauma-related avascular necrosis. Studies suggest that this type of avascular necrosis may develop in more than 20 percent of people who dislocate their hip joint.

Some medicines such as Corticosteroids are commonly used to treat diseases in which there is inflammation, such as systemic lupus erythematosus, rheumatoid arthritis, and vasculitis. Studies suggest that long-term, systemic (oral or intravenous) corticosteroid use is associated with 1/3 of all cases of non-traumatic avascular necrosis. The current theory is corticosteroids may interfere with the body's ability to break down fatty substances. These substances then build up in and clog the blood vessels, causing them to narrow. This makes less blood to gets to the bone. Excessive alcohol use and corticosteroid use are two of the most common causes of non- traumatic avascular necrosis. In people who drink an excessive amount of alcohol, fatty substances may block blood vessels causing a decreased blood supply to the bones that results in avascular necrosis.

Other risk factors or conditions associated with non-traumatic avascular necrosis include Gaucher's disease, pancreatitis, radiation treatments and chemotherapy, and blood disorders such as sickle cell disease. Avascular necrosis strikes both men and women and affects people of all ages. It is most common among people in their thirties and forties. Depending on a person's risk factors and whether the underlying cause is trauma, it also can affect younger or older people.

In the early stages of avascular necrosis, patients may not have any symptoms. As the disease progresses, however, most patients experience joint painat first, only when putting weight on the affected joint, and then even when resting. Pain usually develops gradually and may be mild or severe. If avascular necrosis progresses and the bone and surrounding joint surface collapses, pain may develop or increase dramatically. Pain may be severe enough to limit the patient's range of motion in the affected joint. The period of time between the first symptoms and loss of joint function is different for each patient, ranging from several months to more than a year.

The Center for Regenerative Medicine in Miami, Florida concentrates on helping arthritic and injured people to get back to a functional level of life and their activities using non-surgical techniques and Orthopedic medicine. The center's expertise is in treatment of conditions of spine, knees, shoulders and other cartilage damages. We have developed non-surgical and rehabilitation techniques focused on treatment and management of joint pain. Our team includes health professionals organized around a central theme.

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Regenerative Medicine is Now being Used for Treatment of Avascular Necrosis

Harvard Bioscience's "InBreath" Bioreactors Used in World's First Successful Regenerated Laryngotracheal Transplants

First Two Transplants Performed in Government-Approved Clinical Trial in Russia

HOLLISTON, Mass., June 26, 2012 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc. (HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, announces that its "InBreath" bioreactors were used for the world's first and second successful laryngotracheal implants, using synthetic laryngotracheal scaffolds seeded with cells taken from the patients' bone marrow. The surgeries took place at Krasnodar Regional Hospital in Krasnodar, Russia on June 19th and June 21st. The recipients of the implants, Julia T. and Aleksander Z., are recovering well. The implants in the procedures were grown in bioreactors developed by the regenerative medicine device business of Harvard Bioscience.

The transplants, which required more than a half-year of preparation, were performed on the first two patients enrolled in an ongoing clinical trial at Krasnodar Regional Hospital. The Russian Ministry of Health has approved a clinical protocol for an unlimited number of patients in this trial, all of which will involve trachea procedures.

Each bioreactor was specifically adapted by Harvard Bioscience to the clinical requirements for each patient. Each bioreactor was loaded with a synthetic scaffold in the shape of the patient's original organ. The scaffolds were then seeded with the patient's own stem cells. Over the course of about two days, the bioreactor promoted proper cell seeding and development. Because the patients' own stem cells were used, their bodies have accepted the transplants without the use of immunosuppressive drugs.

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13437

The procedures are the result of a global collaboration involving organizations in the US, Sweden, Russia, Germany, and Italy:

-- The bioreactors were developed, manufactured and prepared by teams at Hugo Sachs Elektronik, a German subsidiary of Harvard Bioscience and at Harvard Bioscience, based in Massachusetts, U.S.A.

-- The scaffolds were created by US-based Nanofiber Solutions.

-- The principal transplant surgeon and main coordinator for both procedures was Dr. Paolo Macchiarini, Professor of Regenerative Surgery at Karolinska Institute in Stockholm.

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Regenerative medicine pioneer continues changing lives with first successful laryngotracheal implants

HOLLISTON, Mass., June 26, 2012 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc. (HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, announces that its "InBreath" bioreactors were used for the world's first and second successful laryngotracheal implants, using synthetic laryngotracheal scaffolds seeded with cells taken from the patients' bone marrow. The surgeries took place at Krasnodar Regional Hospital in Krasnodar, Russia on June 19th and June 21st. The recipients of the implants, Julia T. and Aleksander Z., are recovering well. The implants in the procedures were grown in bioreactors developed by the regenerative medicine device business of Harvard Bioscience.

The transplants, which required more than a half-year of preparation, were performed on the first two patients enrolled in an ongoing clinical trial at Krasnodar Regional Hospital. The Russian Ministry of Health has approved a clinical protocol for an unlimited number of patients in this trial, all of which will involve trachea procedures.

Each bioreactor was specifically adapted by Harvard Bioscience to the clinical requirements for each patient. Each bioreactor was loaded with a synthetic scaffold in the shape of the patient's original organ. The scaffolds were then seeded with the patient's own stem cells. Over the course of about two days, the bioreactor promoted proper cell seeding and development. Because the patients' own stem cells were used, their bodies have accepted the transplants without the use of immunosuppressive drugs.

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13437

The procedures are the result of a global collaboration involving organizations in the US, Sweden, Russia, Germany, and Italy:

-- The bioreactors were developed, manufactured and prepared by teams at Hugo Sachs Elektronik, a German subsidiary of Harvard Bioscience and at Harvard Bioscience, based in Massachusetts, U.S.A.

-- The scaffolds were created by US-based Nanofiber Solutions.

-- The principal transplant surgeon and main coordinator for both procedures was Dr. Paolo Macchiarini, Professor of Regenerative Surgery at Karolinska Institute in Stockholm.

-- Dr. Macchiarini was assisted by a team of surgeons including Dr. Vladimir Porhanov, Chief Doctor of Krasnodar Regional Hospital and head of the Oncological and Thoracic Department of Kuban State Medical University; thoracic surgeons Dr. Igor Polyakov and Dr. Nikolay Naryzhnyi, of Krasnodar Regional Hospital; Dr. Anatoly Zavrazhnov, deputy chief of Krasnodar Regional Hospital; and Dr. Sergey Sitnick, anesthesiologist and head of Krasnodar Regional Hospital's intensive care unit.

-- Dr. Alessandra Bianco at University of Rome, Tor Vergata, performed mechanical testing during scaffold development.

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Photo Release -- Harvard Bioscience's "InBreath" Bioreactors Used in World's First Successful Regenerated ...

What if dying patients waiting for an organ transplant could receive a custom, lab-grown replacement rather than waiting for a donor organ?

To some, this may sound like science fiction -- and in many ways, it still is. But the advances in the field of regenerative medicine that made headlines last week suggest such lab-grown organs may become reality in the future.

One of these advances was Swedish scientists' creation of a custom vein that has carried blood from a little girl's intestines to her liver for a year and counting. In another, a group in Japan successfully implanted lab-grown livers made from human cells into mice -- organs that metabolized drugs the way they would in a human.

And these developments may be just the tip of the iceberg. From skin to blood vessels to solid organs, work is underway to offer more options for patients with faulty or damaged body parts.

Dr. Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine in Winston-Salem, N.C., was part of the first group in the world to successfully implant a lab-grown organ into the human body. Atala's interest in the field began when he was training to become a urologist and saw numerous children who had undergone bladder replacement surgery. Many of them were experiencing leaks, and some even suffered ruptures of their new bladders.

"That's when I really thought, 'Why not try to grow these children new bladders from their own cells?'" Atala said.

Atala collected a small number of cells -- about the size of half a postage stamp -- from the original, inadequate bladders of children with spinal cord birth defects. Each child's own cells were multiplied in the lab and then placed on a biodegradable scaffolding. In seven weeks, the cells had grown to fill in the scaffold, creating a new bladder. The procedure was first performed in 1998, and by 2006 they had seen long-term success of the organs.

"I still hear from some of them occasionally," Atala said. "They are still walking around with their engineered bladders, and they are happy with them."

Since this first foray into growing organs, Atala has been one of the many doctors on the forefront of what some say could one day be a new paradigm in medicine -- growing spare parts from a patient's own cells.

Atala currently heads up more than 300 researchers in the Wake Forest University lab who are working on growing more than 30 different organs and body tissues.

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Lab-Grown Organs May Be the Future

Public release date: 21-Jun-2012 [ | E-mail | Share ]

Contact: Karen Richardson krchrdsn@wakehealth.edu 336-716-4453 Wake Forest Baptist Medical Center

WINSTON-SALEM, N.C. June 21, 2012 Regenerative medicine researchers at Wake Forest Baptist Medical Center have reached an early milestone in a long-term project that aims to build replacement kidneys in the lab to help solve the shortage of donor organs.

In proof-of-concept research published online ahead of print in Annals of Surgery, the team successfully used pig kidneys to make "scaffolds" or support structures that could potentially one day be used to build new kidneys for human patients. The idea is to remove all animal cells leaving only the organ structure or "skeleton." A patient's own cells would then be placed on the scaffold, making an organ that the patient theoretically would not reject.

While this is one of the first studies to assess the possibility of using whole pig kidneys to engineer replacement organs, the idea of using organ structures from pigs to help human patients is not new. Pig heart valves removed of cells have been used for more than three decades to provide heart valve replacements in human patients.

"It is important to identify new sources of transplantable organs because of the critical shortage of donor organs," said lead author Giuseppe Orlando, M.D., an instructor in surgery and regenerative medicine at Wake Forest Baptist. "These kidneys maintain their innate three-dimensional architecture, as well as their vascular system, and may represent the ideal platform for kidney engineering."

For the research, pig kidneys were soaked in a detergent to remove all cells, leaving behind the organ's "skeleton," including its system of blood vessels. In addition, the structure of the nephron the kidney's functional unit was maintained. The scaffolds were implanted in animals, where they were re-filled with blood and were able to maintain normal blood pressure, proving that the process of removing cells doesn't affect the mechanical strength of the vessels.

"There are many challenges to be met before this system could be used to engineer replacement kidneys, including problems with blood clots forming in the vessels," said Anthony Atala, M.D., co-author and director of the Wake Forest Institute for Regenerative Medicine. "The kidney is a very complex organ with at least 22 different cell types."

But, the fact that nephron structure is maintained suggests the potential to re-populate the kidney with cells, according to the scientists. They speculate that new cells introduced into the scaffold would recognize their natural niche through physical or chemical signals of the scaffold.

While the project is in its infancy, the idea represents a potential solution to the extreme shortage of donor kidneys. According to the authors, the probability in the U.S. of receiving a kidney transplant within five years of being added to the waiting list is less than 35 percent. As of late August 2011, nearly 90,000 patients in the U.S. were waiting for kidney transplants.

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Lab-engineered kidney project reaches early milestone

FRANKLIN, Tenn.--(BUSINESS WIRE)--

Numerous presentations were made today during the Regenerative Strategies Forum at the 2012 American Orthopaedic Foot and Ankle Society (AOFAS) annual meeting in San Diego, CA which supported the safety, effectiveness, clinical need, biologic rationale and cost effectiveness of Augment Bone Graft from BioMimetic Therapeutics, Inc. (BMTI).

Regenerative Strategies and Emerging Technologies Pre-meeting Presentations

The forum included lectures by numerous leading foot and ankle surgeons covering regenerative strategies related to foot and ankle surgery. The following presentations highlighted the clinical and pharmaco-economic need and biologic rationale for Augment Bone Graft as an alternative to autograft.

AOFAS Annual Meeting Presentations and Poster

In addition to the above presentations given today at the regenerative forum, the following presentations related to the clinical need for Augment or Augment Injectable Bone Graft will be presented later during the AOFAS annual meeting.

Exhibit Booth

In addition to these surgeon presentations at the AOFAS annual meeting, BioMimetic will host a commercial exhibit booth #401 in the Sapphire Ballroom at the Hilton Bayfront Hotel from June 21 23.

About BioMimetic Therapeutics

BioMimetic Therapeutics (BMTI) is a biotechnology company specializing in the development and commercialization of clinically proven products to promote the healing of musculoskeletal injuries and diseases, including therapies for orthopedics, sports medicine and spine applications. All Augment branded products are based upon recombinant human platelet-derived growth factor (rhPDGF-BB), which is an engineered form of PDGF, one of the body's principal agents to stimulate and direct healing and regeneration. Through the commercialization of this patented technology, BioMimetic seeks to become the leading company in the field of regenerative medicine by providing new treatment options for the repair of bone, cartilage, tendons and ligaments.

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Presentations from the Regenerative Strategies and Emerging Technologies Forum at the American Orthopedic Foot and ...

EDINBURGH, Scotland, June 18, 2012 /PRNewswire/ --A revolution in modern medicine is quietly under way in Scotland, which is rapidly emerging as a global leader in regenerative medicine and drug discovery.

Ranked #1 in the world for stem cell research, Scotland recently launched a new stem cell trial to cure corneal blindness, which could result in the development of the first harvest stem cells that restore the sight of millions of people. The revolutionary research, conducted by Advanced Cell Technologies at the Aberdeen Royal Infirmary, is the first trial of its kind ever to be carried out in the UK.

Scotland is also responsible for many other groundbreaking life science discoveries, including MRI and CAT scanners, the discovery of p53 cancer suppressor gene, world-recognized research in diabetes and cancer, ReNeuron's stem cell trial for stroke patients, and the cloning of "Dolly" the sheep.

More than two dozen Scottish life science companies and research organizations will come together to showcase these discoveries among other recent life science developments at the 2012 BIO International Convention on June 18-21 in Boston.

"Scotland may be small in size, but we're big in bioscience," said Danny Cusick, President, Americas, of Scottish Development International. "Scotland is home to some of the world's leading life science companies and has the largest concentration of animal science-related expertise and more medical research per capita than any other country in Europe."

The University of Dundee and the University of St. Andrews are both ranked among the top 10 best international academic institutions for scientists. Little wonder that the University of Dundee and the Medical Research Council just announced more than $21 million in funding from a consortium of six of the world's leading pharmaceutical companies for continuing research on the development of new drug treatments of major global diseases.

Beyond the universities, Scotland is also investing heavily in infrastructure to support development of its life science sector. Case in point is the expansive new Edinburgh BioQuarter (EBQ), which just celebrated the opening of pioneering bio-medical facilities: The Scottish Centre for Regenerative Medicine and new bio-incubator building, Nine. The EBQ was designed to foster collaboration between Scottish researchers and global life science companies that is conducive to developing and commercializing new medical discoveries.

Likewise, a former Merck research facility in Scotland's Central Belt between Glasgow and Edinburgh, is being transformed into "BioCity Scotland" to foster the growth of life science and pharmaceutical companies.

Scottish companies are also beginning to attract the notice of venture capitalists and angel funds. Boston-based Morningside Ventures, for example, recently supported Scotland-based NuCana BioMed with Series A funding.

Scotland's medical research expertise is also earning recognition on the West Coast as the country signed a Memorandum of Understanding with the prestigious San Francisco-based Californian Institute of Regenerative Medicine earlier this year, which will enable joint research and collaboration between scientists and companies in Scotland and California.

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From Cloning 'Dolly the Sheep' to Curing Blindness, Scotland is on the Forefront of Life Science Discoveries

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

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the company is presenting at two upcoming conferences: the 2012 Bio International Convention and Clinical Outlooks for Regenerative Medicine meeting, both in Boston, on Tuesday, June 19. The presentations will cover the companys three ongoing clinical trials using human embryonic stem cell-derived retinal pigment epithelial cells to treat macular degeneration, and other programs.

Gary Rabin, chairman and CEO, will present at the 2012 Bio International Convention on Tuesday, June 19 at 8:15 a.m. EDT, at the Boston Convention & Exhibition Center.

Matthew Vincent, Ph.D., director of business development, will present at the Clinical Outlooks for Regenerative Medicine meeting at 9:15 a.m. EDT on the same date, at the Starr Center, Schepens Eye Research Institute, at 185 Cambridge Street in Boston.

Both presentation slide decks will be available on the conference presentations section of the ACT website.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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Advanced Cell Technology to Present at the 2012 Bio International Convention and the Clinical Outlooks for ...

MADISON, Wis.--(BUSINESS WIRE)--

Stratatech Corp., a leader in regenerative medicine, today announced that StrataGraft, the companys universal human skin substitute, has been designated an orphan drug by the U.S. Food and Drug Administration for the treatment of partial and full thickness skin burns.

Orphan drug designation provides a number of benefits to the company, including seven years of market exclusivity once StrataGraft receives FDA clearance, assistance from the FDA with guiding StrataGraft through the regulatory approval process, waiver or partial payment of application fees and tax credits for clinical testing expenses conducted after orphan designation is received.

This orphan drug designation marks an important milestone in Stratatechs regulatory strategy and complements the highly encouraging clinical results we reported at the end of April, said Lynn Allen-Hoffmann, Ph.D., Stratatechs chief executive and chief scientific officer. The FDAs designation underscores the need for new treatments for severely burned patients. We look forward to working with the agency to expedite the continuing clinical testing and regulatory review of StrataGraft.

StrataGraftskin substitute is a living, cell-based tissue with the physical, chemical and histological characteristics of human skin. It is being evaluated in a multicenter clinical study designed to assess its safety and utility in the treatment of patients with second-degree deep partial-thickness burns. The trial enables a direct comparison of a single treatment of StrataGraft on one burn site to a control autograft on a comparable burn site of each patient. None of the burns treated with StrataGraft tissue in the first cohort of 10 patients required autografting by day 28, the studys primary efficacy endpoint.

There is an urgent need for new treatment options for burns. Severe burns and other major skin trauma are life-threatening injuries that require immediate surgical intervention. Frequently, this involves temporary coverage of the wound site with cadaver skin or synthetic dressings to prevent infection and dehydration because there are no full-thickness skin substitutes commercially available for the treatment of burns. Permanent closure of the wound is generally accomplished through split-thickness skin autografting after the wound bed is sufficiently stable that it will accept the transplanted tissue. Although this regimen is the standard of care for severe burns, the limited availability of and potential for pathogen transmission from cadaver skin, as well as the painful surgery associated with autografting, are serious drawbacks to this approach. The American Burn Association estimates that 1.1 million people suffer burns annually in the United States. Approximately 45,000 patients require hospitalization.

About Stratatech Corp.

Stratatech Corp. is a privately held regenerative medicine company focused on the development and commercialization of cell-based, tissue-engineered skin substitute products for therapeutic and research applications. These products are made using the companys proprietary NIKS cells a human keratinocyte progenitor cell line that faithfully reproduces normal epidermal skin architecture and barrier function. The company is using this progenitor cell line to create a portfolio of therapeutic products to treat severe burns, non-healing ulcers, and other complex skin defects. The companys flagship product, StrataGraft tissue, is in human clinical testing for the treatment of severe burns and other traumatic skin loss. The companys second therapeutic product, ExpressGraft antimicrobial tissue, is expected to enter clinical testing in 2013 to treat non-healing diabetic foot ulcers.

For more information about Stratatech, its technology and product pipeline, please visit the companys website at http://www.stratatechcorp.com.

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Stratatech’s StrataGraft® Skin Substitute Granted FDA Orphan Drug Designation

11-06-2012 18:26 Strengths of the Saban Research Institute Developmental Biology/Regenerative Medicine Retreat by: David Warburton OBE, DSc, MD, MMM, FRCP, FRCS, FRCPCH Professor of Pediatrics, Surgery and Craniofacial Biology Director, Developmental Biology and Regenerative Medicine Program Director, California Institute for Regenerative Medicine Training Program and Shared Laboratory Saban Research Institute Children¹s Hospital Los Angeles Keck School of Medicine and Ostrow School of Dentistry University of Southern California

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Warburton Strengths of Saban Developmental Biology Regenerative Medicine Dept. - Video

SAN DIEGO, June 11, 2012 /PRNewswire/ --

Shire plc, the global specialty biopharmaceutical company, announced today that its Regenerative Medicine business, Advanced BioHealing, Inc., has entered into a lease agreement with BioMed Realty Trust, Inc. which will allow the company to further expand its operational footprint and presence in the San Diego area over the next several years.

The new campus will provide Shire's Regenerative Medicine business the increased capacity it needs to meet future demand for its lead product, DERMAGRAFT, while offering additional space and infrastructure to manufacture new regenerative medicine products, in alignment with the business' strategic growth plan.

"We are committed to investing in and expanding our Regenerative Medicine business and with the signing of this lease, we are pleased to confirm and build our presence in San Diego with BioMed Realty as our real estate partner," said Kevin Rakin, Shire's Regenerative Medicine President. "This new campus will give us the flexibility and increased capacity we need to develop and manufacture new regenerative medicine therapies and build our foundation for continued growth in this exciting field."

Phase I of the site development will be in excess of 150,000 square feet and will house the company's manufacturing and associated support operations, commercial operations, corporate, and administrative functions. This expansion could create several hundred local jobs once the regenerative medicine campus is operational.

"Shire's commitment to growing its Regenerative Medicine business in San Diego is important to a region where one-in-10 people remain unemployed," said Congressman Brian Bilbray (CA-50). "This investment will not only provide additional opportunities for rewarding, high-paying jobs, but will ensure that San Diego remains a leader in the development of innovative patient care."

Shire expects to begin construction of the new campus in Sorrento Mesa in 2013, with initial occupancy targeted for 2014.

"We are pleased to enter into this partnership with Advanced BioHealing, which is the culmination of extensive, collaborative efforts by both companies to identify and execute on a real estate solution which will fully support their development and manufacturing needs," said Alan D. Gold, Chairman and Chief Executive Officer of BioMed Realty. "We look forward to working closely with the Advanced BioHealing and Shire teams to develop this future multi-phase campus for the development and commercialization of important regenerative medicine therapies."

The company plans to maintain its current DERMAGRAFT manufacturing facility on North Torrey Pines Road in La Jolla, CA, which currently employs nearly 200 people.

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Shire's Advanced BioHealing Commits to Developing Regenerative Medicine Campus in San Diego

Miami, Florida (PRWEB) June 11, 2012

"Osteoarthritis of the knee is now being treated with regenerative medicine at he center for regenerative medicine." according to A.J. Farshchian MD an orthopedic regenerative practitioner at the center for regenerative medicine.

Knee pain is the most common condition seen at The Center for Regenerative Medicine, with 90% of the patient load being some type of knee pain, top ten etiologies of Knee pain treated are: #1 Osteoarthritis Osteoarthritis is by far the most common cause of knee pain seen at The Center for regenerative Medicine.

#2 Tear of Meniscus Typically caused by a sudden twist of the knee, is also very common, seen mostly in athletes.

#3 ACL Damage This is typically caused during Sports events.

#4 Obesity Obesity is a common problem in USA. It is estimated that a majority of obese people develop knee pain.

#5 Chondromalacia Chondromalacia is softening of the cartilage behind the knee cap.

#6 Baker's Cyst Typically accompanies Osteoarthritis, This is a painful swelling behind the knee.

#7 Osgood-Schlatter Disease Osgood-Schlatter disease is a condition seen mostly in adolescents male.

#8 Osteochondritis Dissecans Osteochondritis dissecans also a condition seen in young people.

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Osteoarthritis of the knee is now being treated with regenerative medicine at he center for regenerative medicine.

CLEARWATER, FL--(Marketwire -06/08/12)- Biostem U.S., Corporation, (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, today reported that it has engaged Acropolis Inc. http://www.acropolisinc.com, a full-service advertising agency located in Orlando, Florida, to lend their expertise in brand building, marketing, and advertising development and placement.

Biostem Chief Executive Officer Dwight Brunoehler stated, "After several months of interviewing prospective agencies, we have come to the conclusion that Acropolis is the one to assist us in executing our plans. Their notable work in multiple media areas is impressive, to say the least. Their client list including The University of Florida, Arby's Restaurants, and the City of Orlando, speaks for itself."

Acropolis Principal, Scott Major, said, "This is a great fit for Acropolis. Our entire team loves the Biostem business approach in the incredible field of regenerative medicine. The hair re-growth field in which we will be marketing the Biostem technology is enormous. We are pleased to be a part of Biostem's expansion."

About Biostem U.S. CorporationBiostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S., Corporation is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

For further information, contact Fox Communications Group at 310-974-6821, or view the Biostem website at http://www.biostemus.com.

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Biostem U.S., Corporation Engages Acropolis Agency to Assist in Implementing Its International Marketing Plan

Miami, Florida (PRWEB) June 07, 2012

"Chronic exertional compartment syndrome now treated at the center for regenerative medicine." according to Dr. A.J. Farshchian MD the medical director for the center for regenerative medicine.

Due to the fact that patients typically present with a normal examination as well as non-impressive diagnostic findings Diagnosis is usually overlooked: Chronic exertional compartment syndrome may prove a challenge to detect, and acute compartment syndrome may require immediate surgical intervention. The cause is described as when a muscle becomes too big for the sheath that surrounds it causing pain.

The enlarged muscle blocks the flow of blood producing ischemia which in turns produces pain. The large muscle on the outside of the shin area is called the tibialis anterior and is surrounded by a sheath. This is called the anterior compartment of the lower leg. Over use of this muscle causes swelling, the compartment most often involved is the anterior.

Lateral compartment is also a common place for involvement of overuse. Usually, a patient with chronic exertional compartment syndrome has no symptoms at rest. Compartment pressures may remain elevated for up to 40-60 minutes after exercise.

The Center for Regenerative Medicine in Miami, Florida concentrates on helping arthritic and injured people to get back to a functional level of life and their activities using non-surgical techniques and Orthopedic medicine. The center's expertise is in treatment of conditions of spine, knees, shoulders and other cartilage damages. We have developed non-surgical and rehabilitation techniques focused on treatment and management of joint pain. Our team includes health professionals organized around a central theme.

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Chronic Exertional Compartment Syndrome Now Treated at the Center for Regenerative Medicine

SAN DIEGO, CA--(Marketwire -06/06/12)-

Bio-Matrix Scientific Group (BMSN) (BMSN) announced today that its Regen BioPharma unit has appointed three internationally renowned regenerative medicine experts to its Scientific Advisory Board (SAB). The new SAB members appointed are David White, M.D., PhD; Wei-Ping Min, M.D., PhD and Vlad Bogin, M.D.

Dr. White is a member of the Surgery and Immunology faculty of The Schulic School of Medicine, University of Western Ontario. He is one of the leading experts on using regenerative medicine transplant procedures to treat pancreatic conditions, including diabetes. He is also the Chief Scientific Officer of Sernova Corp and was formerly a Therapeutic Area Head for Novartis. He received the B.Sc. degree from the University of Surrey and the M.D. and PhD degrees from Cambridge University.

Dr. Wei-Ping Min is Professor at the Lawson Health Research Center in Canada. He is inventor of siRNA therapeutics in the area of immunology and cell therapy to inhibit disease modalities. He is also the founder/cofounder of several biotech companies including MedVax Pharma Corp, and ToleroTech Inc. Dr. Min brings detailed scientific and mechanistic expertise to Regen BioPharma. He earned graduate and medical degrees from Nanchang University Medical School and the PhD degree from Kyushu University.

Dr. Bogin is the President and CEO of Cromos Pharma, a contract research organization that specializes in biopharmaceutical clinical outsourcing. He was formerly the Director of Boehringer Ingelheim in charge of the phase IV program for Dabigatran Etexilate. He studied at the Yale University School of Medicine and the University of Rochester School of Medicine and Dentistry.

Regen BioPharma has also entered into a Letter of Intent with Clinartis LLC, a global contract research organization (CRO). Clinartis is a full service global CRO serving pharmaceutical, biotech and medical device companies to support Phase I - IV drug and device clinical trials in the US and Europe.

The SAB and Clinartis will assist the Company in its acquisition of intellectual property related to stem cells, translation of the intellectual property into treatments, and optimizing the value of these new therapies.

"The potential of regenerative medicine products is significant," says Christopher Mizer, the President of Regen BioPharma. "We believe that strategic collaborative relationships between Regen BioPharma, our SAB and Clinartis will facilitate our efforts to create value from that potential by developing proprietary, life sciences technologies and demonstrating their clinical utility."

"Our strong SAB has scientific and regulatory expertise, coupled with Clinartis' access to world-class researchers and investigators will be very instrumental for accelerated commercialization of the cutting-edge biotechnology research on which Regen BioPharma is focused," according to Bio-Matrix Scientific Group's Chairman & CEO David Koos.

About Bio-Matrix Scientific Group Inc. and Regen BioPharma, Inc.:

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Bio-Matrix' Regen BioPharma Unit Establishes Scientific Advisory Board and Research Relationship With Clinartis in ...

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

Regenerative medicine company Histogenics Corporation, announced today publication in the Journal of Bone and Joint Surgery (JBJS) of two year results from a Phase 2 randomized clinical trial of the Companys lead product candidate, the NeoCart Autologous Cartilage Tissue Implant (ACTI) for patients with grade III chondral injury to the femur (cartilage damage in the knee). The paper concludes that NeoCart:

NeoCart is an autologous bioengineered neocartilage grown outside the body using the patients own cells for the repair of full thickness cartilage lesions. A multi-center, randomized Phase 3 study of the product candidate is underway comparing treatment of articular cartilage defects of the knee with NeoCart versus current standard of care, microfracture surgery. In current clinical practice, microfracture surgery, which works by creating tiny fractures in the underlying bone, is widely recommended as a primary treatment for chondral injury to the femur, although outcome measures have been reported to plateau between 12 to 24 months. Prior to the NeoCart study featured in the JBJS, no studies of microfracture alternatives had shown a significant clinical improvement when directly compared to microfracture before and up to two years of treatment.

There is a clinical need for a primary surgical treatment option for cartilage repair that improves on the historical outcomes of microfracture and the results detailed in our recent analysis and publication strongly suggest that NeoCart may meet this need as a first-line therapeutic alternative to microfracture procedures, said Dennis Crawford,M.D., Ph.D.,Assistant Professor, Orthopedics Oregon Health Science University and the lead author of the paper. Preliminary findings strongly suggest that autologous cartilage tissue implant using NeoCart significantly improved knee pain and function within six months and provided significantly greater improvements, in a greater proportion of patients than microfracture. This includes, importantly, greater clinical efficacy two years after treatment in contrast to those treated with microfracture surgery.

Histogenics is committed to improving the quality of life for active adults and elite athletes by developing innovative solutions upstream to the current standard of less efficacious or more invasive treatment modalities, said Patrick ODonnell, President and Chief Executive Officer of Histogenics. The analysis in JBJS adds to a growing body of evidence that NeoCart has the potential to be a longer-term, effective solution for cartilage injurywhich is especially encouraging for young, active adults who are eager to return to their pre-injury activities and want to avoid more invasive, bridge-burning treatments during these prime years of their lives. Based on these continued positive findings, we are hopeful that NeoCart could become a valuable addition to the treatment armamentarium for cartilage damage and look forward to completing our ongoing NeoCart Phase 3 clinical study.

In the JBJS paper, three, six, twelve, and twenty-four month data were reported with a mean of 26 months for all patients (21 NeoCart; 9 microfracture). Mean age, body mass index, injury acuity and lesion size were similar across both arms. Adverse event rates did not differ between treatment arms. Short Form (36) Health Survey, Knee injury and Osteoarthritis Outcomes Score (KOOS) activity of daily living, KOOS quality of life and International Knee Documentation Committee (IKDC) score improved from baseline (p<0.05) at two years for both treatments. Improvement for NeoCart versus baseline was significant (p<0.05) for all measures at 6, 12 and 24 months. NeoCart treatment improvement was statistically greater (p<0.05) than microfracture for KOOS pain at 6, 12 and 24 months, KOOS symptoms at 6 months, IKDC, KOOS sports and Visual Analog Scale pain at 12 and 24 months, and KOOS quality of life at 24 months. Analysis of covariance at one year indicated that KOOS pain (p=0.016) and IKDC (p=0.028) change from pre-treatment Ievels favored NeoCart. Significantly more NeoCart treated patients (p=0.0125) were therapeutic responders at 6 (43% v. 25%) and 12 (76% v. 22%) months. This trend continued as a greater proportion of NeoCart treated patients (15/19) were therapeutic responders at 24 months than microfracture treated participants (4/9). In the responder analysis, a patient was classified as a responder if they achieved at least a 12-point improvement in the pain score of the KOOS assessment and a 20-point improvement in the IKDC subjective score.

The paper, titled NeoCart, an Autologous Cartilage Tissue Implant, Compared to Microfracture for Treatment of Distal Femoral Cartilage Lesions. An FDA Phase II Prospective, Randomized Clinical Trial after Two Years, was authored by Dennis Crawford,M.D., Ph.D.,Assistant Professor, Orthopedics Oregon Health Science University, Thomas DeBerardino, M.D., Associate Professor, Orthopaedic Surgery, New England Musculosketal Institute at University of Connecticut Health Center and Riley Williams, III, M.D., Associate Professor, Orthopaedic Surgery, Weill Medical College of Cornell University, Hospital for Special Surgery.

In addition to the results reported today in JBJS, data were also presented last month at the International Cartilage Repair Society Annual Meeting from previously completed Phase 1 and 2 clinical trials that demonstrated that NeoCart efficacy was sustained throughout a median study period of 48 months and, in the first patients treated with NeoCart, for up to 5 years.

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.

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Histogenics Announces Publication in Journal of Bone and Joint Surgery Demonstrating that NeoCart® is Associated with ...

NORTHRIDGE, Calif. & CAMBRIDGE, U.K.--(BUSINESS WIRE)--

Avita Medical Ltd. (ASX: AVH) (OTC: AVMXF) (OTCQX:AVMXY), the regenerative medicine company, today announced a free issuance period through the Bank of New York Mellon whereby AVMXF shareholders may bundle their shares into American Depository Receipts (ADRs) to trade under the AVMXY symbol. The bundling fee will be waived by the Bank of New York Mellon for the three-month period starting June 11, 2012 and ending on September 11, 2012.

Avita Medical trades its ordinary shares on the Australian Stock Exchange under the AVH symbol. The AVMXF shares represent ordinary Australian shares that have been settled in US dollars. Each AVMXY ADR consists of a bundle of 20 ordinary shares.

Conversion of AVMXF shares allows US investors to freely trade ADRs, thereby avoiding the costs and complexities, including currency exchange fluctuations, involved in buying shares on foreign exchanges.

This is an excellent opportunity for our U.S. investors to bundle their AVMXF shares into AVMXY ADRs, for which we anticipate increased trading volume over time, said William Dolphin, Ph.D., CEO of Avita Medical. BNY Mellon has graciously offered to waive the bundling fee for our shareholders for a three month period. We encourage all interested AVMXF shareholders to visit our website or contact BNY Mellon to take advantage of this opportunity.

Investors holding AVMXF shares who are interested in bundling their shares into the AVMXY ADRs should contact the Companys transfer agent, Bank of New York Mellon (BNY Mellon):

Kristen Resch Bank of New York Mellon Depository Receipts +1-212-815-2213 kirsten.resch@bnymellon.com

ABOUT AVITA MEDICAL LTD.

Avita Medical (http://www.avitamedical.com/) develops and distributes regenerative and tissue-engineered products for the treatment of a broad range of wounds, scars and skin defects. Avitas patented and proprietary tissue-culture, collection and application technology provides innovative treatment solutions derived from a patients own skin. The companys lead product, ReCell Spray-On Skin, 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 by federal law to investigational use. A Phase III FDA trial is in process.

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Avita Medical Announces Free Issuance Period for Conversion of AVMXF Shares to AVMXY ADRs

CLEARWATER, FL--(Marketwire -06/01/12)- Biostem U.S., Corporation (HAIR) (HAIR) (Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine science sector, has made its Scientific and Medical Board of Advisors publications available on the company website, http://www.biostemus.com.

Chief Executive Officer Dwight Brunoehler stated, "The company is very proud of the many contributions its SAMBA members have made, and continue to make, to the medical community. As their publications and credentials show, this is a very prestigious and influential group. Having worked with them in past projects and now at Biostem, I know them all to be active participants in the development and guidance of the company's objectives. Their diversified areas of expertise and backgrounds are already playing a major role in assisting the company as it moves forward into the expanding field of regenerative medicine."

About Biostem U.S., Corporation Biostem U.S., Corporation is a fully reporting Nevada corporation with offices in Clearwater, Florida. Biostem is a technology licensing company with proprietary technology centered on providing hair re-growth using human stem cells. The company also intends to train and license selected physicians to provide Regenerative Cellular Therapy treatments to assist the body's natural approach to healing tendons, ligaments, joints and muscle injuries by using the patient's own stem cells. Biostem U.S., Corporation is seeking to expand its operations worldwide through licensing of its proprietary technology and acquisition of existing stem cell related facilities. The company's goal is to operate in the international biotech market, focusing on the rapidly growing regenerative medicine field, using ethically sourced adult stem cells to improve the quality and longevity of life for all mankind.

More information on Biostem U.S., Corporation can be obtained through http://www.biostemus.com, or by calling Fox Communications Group 310-974-6821.

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Biostem U.S., Corporation Presents Scientific and Medical Board of Advisors Publications