StemCell Therapy

ALPHARETTA, Ga.--(BUSINESS WIRE)--

SANUWAVE Health, Inc. (SNWV), today announced the publication of peer-reviewed, preclinical research that demonstrates the ability of the Companys Extracorporeal Shock Wave Technology (ESWT) to stimulate proliferation of periosteal adult stem cells (cambium cells) within the body and subsequently form bone. In addition, the combination of ESWT-proliferated adult stem cells and a bioactive scaffold regenerated more bone than a bioactive scaffold alone.

The publication, titled The Use of Extracorporeal Shock Wave-Stimulated Periosteal Cells for Orthotopic Bone Regeneration, appeared in the online edition of Tissue Engineering, Part A as an ePublication ahead of print. The abstract of the publication can be viewed online at: http://online.liebertpub.com/doi/abs/10.1089/ten.TEA.2011.0573.

Led by Myron Spector, M.D., a professor and researcher at Harvard-MIT Division of Health Sciences and Technology, the authors stated, This study investigated a novel approach for treatment of bone loss, which has potential for many clinical situations where bone apposition is required (e.g., vertical ridge augmentation, regrowing bone following tumor resection, and regenerating bone lost at sites of osteolysis or bone degeneration).

The cambium cells of the periosteum (outer membrane covering bone) currently have limited suitability for clinical applications in their native state due to their low cell number (only 2 to 5 cells thick). However, ESWT has been shown to cause a rapid increase in periosteal cambium cell numbers and subsequent periosteal osteogenesis (bone formation). The advantages of adding a scaffold as we did in this study are threefold: the scaffold contours the new bone, it helps maintain bone at the implant site, and it creates a space to allow the periosteal cells to further proliferate and fill the scaffold.

The authors concluded, The ESWT-stimulated samples of tibial bone outperformed the control group in all key outcome variables, and the study results therefore demonstrated the efficacy of ESWT-stimulated periosteum for bone generation. These results successfully demonstrated the efficacy of periosteum stimulated by ESWT technology for bone generation.

In the first phase of this research, the authors successfully demonstrated that ESWT increased the thickness of the cambium layer surrounding bone and the number of cambium cells within that layer. This proliferation of adult stem cells is an important part of many tissue engineering strategies. Then, in a novel second phase, the authors combined the ESWT-proliferated adult stem cells with a porous calcium phosphate scaffold that is commonly utilized in clinical applications to stimulate bone regeneration. A comparator control group received the scaffold alone with no prior ESWT treatment. The results were statistically significant and favored the ESWT group. In fact, at two weeks post-surgery, there was a significant increase in all key outcome variables for bone growth favoring the group that received ESWT prior to being combined with a scaffold compared with the group that received only the scaffold.

Summary of Key Study Findings

About SANUWAVE Health, Inc. SANUWAVE Health, Inc. (www.sanuwave.com) is an emerging regenerative medicine company focused on the development and commercialization of noninvasive, biological response activating devices for the repair and regeneration of tissue, musculoskeletal and vascular structures. SANUWAVEs portfolio of products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the bodys normal healing processes and regeneration. SANUWAVE intends to apply its PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE, is CE marked and has Canadian device license approval for the treatment of the skin and subcutaneous soft tissue. In the U.S., dermaPACE is currently under the FDAs Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved Ossatron device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its Ossatron, Evotron and orthoPACE devices in Europe.

Forward-Looking Statements This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Companys ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the marketing of the Companys product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Companys ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Companys periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

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SANUWAVE Technology Shown to Proliferate Stem Cells and Form Bone

Terms Used Across Specialties Advanced clinical services Availability of specified teams, programs, and resources that address the needs of particular types of patients. The mix of services varies by specialty. See individual specialties below. Advanced technologies Availability of specified technologies for diagnosis and treatment. The technologies vary by specialty. See individual specialties below. Clinical support services Access to selected medical and surgical services. The services vary by specialty. See individual specialties below. Committing to best practices Use of guidelines, registries, and other accepted measures. The measures vary by specialty. See individual specialties below. Committing to quality improvement Participation in activities that can enhance care, such as external review of patient and parent satisfaction, public reporting of quality-related performance data, and participating in national quality initiatives. Engaging parents and family Enlistment of family members in the care process. Having a parent advisory committee; parents or family members on two key standing committees; and involving parents in clinical decisions through family-centered rounds, care conferences, and other participatory programs are examples. Infection-prevention program Indicates diligence and success in reducing hospital-acquired infections through proven measures such as hand hygiene, vaccination, and use of antimicrobials. Nurse Magnet hospital Meets American Nurses Credentialing Center standards for excellence in nursing care. Nurse-patient ratio Relative ratio of fulltime registered nurses to daily average number of inpatients. The higher the ratio, the more nurses caring for patients. In Neonatology, the ratio reflects the number of neonatal ICU nurses and the average daily number of NICU patients. Patient and family services Reflects how many of these services are offered: family resource center, sleep rooms for parents and siblings, school intervention program, Ronald McDonald house or other residential facility, and family access to certified child life specialists, family support specialists, pediatric psychologists, and interpreters. Availability of additional services in Neonatology and Nephrology is shown below. Patient volume Relative number of patients in past year who had certain specified disorders or received specified procedures). Procedure volume Relative number of tests and noninvasive procedures (in Orthopedics, the relative number of tests and surgical procedures. Rank The top 50 hospitals in 10 specialties are ranked by U.S. News Score. Reputation with specialists Percentage of pediatric specialists responding to U.S. News surveys who named hospital as among the best for especially challenging cases and procedures. Responses were combined from surveys in 2010, 2011, and 2012. Specialized clinics and programs Availability of certain defined programs for patients with particular conditions. The programs vary by specialty. See individual specialties below. Success in reducing ICU infections Measures success at minimizing bloodstream infections in pediatric ICU patients. Surgical volume Relative number of patients who had specified operations in past year. Use of health information technology Hospitals received credit for implementation and appropriate use of electronic medical records and computerized physician order entry. U.S. News Score A number from 0 to 100 that sums up a hospital's quality of care as determined by the U.S. News methodology. The top-performing hospital in each specialty automatically received a score of 100. NA Not applicable. NR No response. Specialty-Specific Terms Cancer 100-day BMT survival Survival of patients receiving stem cell transplants at 100 days following transplant. Accredited transplant program Meets standards set by Foundation for the Accreditation of Cellular Therapy for transplanting bone marrow and tissue. Advanced clinical services (out of 18) Examples: primary oncologist participates in more than half of clinical visits with each patient, pediatric cancer pharmacist rounds with care team, consultation with experts in complementary health. Advanced technologies (out of 14) Examples: PET or PET/CT scanner, intraoperative magnetic resonance imaging, intensity-modulated radiation therapy, bone scan. Bone marrow transplant services Number of available bone marrow transplant services, such as transplantation from both related and unrelated donors; recognition by the National Marrow Donor Program; membership in the Pediatric Blood and Marrow Transplant Consortium; transplant volume. Clinical support services (out of 10) Surgical ICU, genetic testing/counseling, pediatric acute pain/sedation service, neonatal ICU, pediatric anesthesia program, pediatric infectious disease program, pediatric pain management program, pediatric ICU, rapid response team, infection control facilities. Committing to best practices (out of 21) Examples: regular morbidity and mortality conferences, quarterly tumor boards, and significant time spent in managing certain conditions. Committing to clinical research (out of 12) Examples: degree of participation in clinical trials and bench-to-bedside research, such as cancer research networks and phase 1 and 2 clinical trials for leukemia, brain tumors, and sarcomas. Fellowship programs (out of 2) Active training programs in pediatric hematology-oncology and pediatric endovascular surgical neuroradiology. Five-year cancer survival Reflects survival of patients with acute lymphoblastic leukemia and neuroblastoma five years after beginning treatment. New-patient volume Relative number of new cancer patients in past two years. Palliative care program Formal program for families of children with end-of-life illnesses or with chronic or life-limiting conditions. Additional credit for cancer patients referred to program. Specialized clinics and programs (out of 9) Examples: clinical brain tumor program, clinical bone and soft tissue sarcomas program, clinical leukemia/lymphoma program, comprehensive longer-term survivors program, pediatric limb-sparing surgery program, and fertility preservation program. Subspecialist availability (out of 14) Having certain specialists, surgeons, and other medical staff available for consultation and care, such as a pediatric anesthesiologist and pediatric head and neck surgeon. Cardiology & Heart Surgery Adult congenital heart program Availability of adult heart program for inherited or congenital heart disorders. Additional credit if program was listed with Adult Congenital Heart Association and if program offers formal plan to transition patients from pediatric to adult program, among other features. Advanced clinical services (out of 18) Examples: dedicated cardiac surgical OR, remote patient monitoring, fetal echocardiographic testing, ventricular assist devices, congenital heart disease clinic, heart failure program. Advanced technologies (out of 5) CT angiography, cardiac MRI, transcatheter arrhythmia ablation, ECMO program available 24/7, transesophageal echocardiographic testing during surgeries. Catheter procedure volume Relative frequency of catheter procedures such as stent and atrial and ventricular tachycardia procedures performed in past year. Clinical support services (out of 9) Surgical ICU, pediatric acute pain/sedation service, neonatal ICU, pediatric anesthesia program, pediatric infectious disease program, pediatric pain management program, pediatric ICU, rapid response team, reverse isolation/infection control facilities. Committing to best practices (out of 21) Examples: participation in regular morbidity and mortality conferences, active home surveillance for infants with heart defects, follow-up program for patients with or at risk for neurodevelopmental complications. Committing to clinical research (out of 10) Degree of participation in clinical trials and bench-to-bedside research. Examples: externally audited, national quality improvement research networks such as Pediatric Heart Research Network, Congenital Cardiac Anesthesia Society, and National Cardiovascular Disease Registry. Congenital heart program Credit for tracking and reporting data and for volume and type of procedures performed, including 100 or more congenital heart procedures in past year and treating at least one patient with a Berlin heart or other ventricular assist device. Fellowship programs (out of 2) Active training programs in pediatric cardiology and thoracic surgery. Heart transplant program Reflects recognition by United Network for Organ Sharing as heart or heart-lung transplant program and number of transplants in past three years Norwood surgery volume Reflects number of Norwood Stage 1 procedures in past year. Specialized clinics and programs (out of 11) Certain catheter procedures offered to one or more patients in past year. Examples: balloon angioplasty, stent implantation, transcatheter occlusion of cardiac shunts, transcatheter arrhythmia ablation, ablation for atrial tachycardia. Subspecialist availability (out of 14) Having certain specialists, surgeons, and other medical staff available for consultation and care, such as a pediatric cardiothoracic surgeon, pediatric cardiac intensivist, interventionalist, and electrophysiologist. Survival after heart transplant Reflects one- and three-year post-transplant survival. Survival after Norwood surgery Reflects survival from Norwood Stage 1 procedure. Survival after surgery Survival following moderately complex to very difficult heart surgery in past two years. Diabetes & Endocrinology Advanced clinical services (out of 19) Examples: certified trainers in continuous glucose monitoring for families; diabetes and endocrinology support staff with social workers, dietitians, and psychologists; diabetes-specific support group for parents and families. Advanced technologies (out of 10) Examples: PET or PET/CT scanning, diagnostic radioisotope scan, endocrine testing, radiation isolation room, thyroidectomy, fine needle aspiration of thyroid nodule. Clinical support services (out of 9) Surgical ICU, genetic testing/counseling, neonatal ICU, pediatric anesthesia program, pediatric infectious disease program, pediatric pain management program, pediatric ICU, rapid response team, reverse isolation/infection control facilities. Committing to best practices (out of 62) Examples: clinical database for assessing quality of diabetes care, written consensus protocols for inpatient management of diabetic ketoacidosis, high percentage of inpatients seen by member of diabetes program, high percentage of outpatients with documented blood sugar results. Committing to clinical research Degree of participation in specialty-specific research activities such as clinical trials and other bench-to-bedside research. Diabetes management Reflects successful prevention of serious problems in children with type 1 diabetes and keeping blood sugar levels in check. Diabetes options How many of four alternatives are available to patients in a pediatric diabetes program: insulin pump for children age 5 or older, insulin pump for children younger than age 5, pump plus basal insulin injection, and basal insulin injection with rapid-acting insulin analog. Fellowship program Active training program in pediatric endocrinology. Hypothyroid management Relative percentage of treated hypothyroid children who test normal and of hypothyroid infants who began treatment before three weeks of age. Specialized clinics and programs (out of 7) Programs for lipid disorders, hypertension, comprehensive weight management, and Turner syndrome; clinics for outpatients with type 2 diabetes, outpatients with pre-diabetes, and adolescents and young adults with diabetes. Subspecialist availability (out of 11) Having certain specialists, surgeons, and other medical staff available for consultation and care, such as pediatric neurosurgeon and pediatric endocrinologist. Gastroenterology Advanced clinical services (out of 8) Examples: pediatric GI and liver specialists; pediatric interventional radiologists; support groups for inflammatory bowel disease, celiac disease, liver disease and other digestive disorders. Advanced technologies (out of 10) PET or PET/CT scanner, magnetic resonance cholangiopancreatography, magnetic resonance enterography, dual-emission X-ray absorptiometry (DXA) scan, capsule endoscopy, endoscopic band ligation, esophageal impedance monitoring, endoscopic retrograde cholangiopancreatography, and antroduodenal and full colonic motility studies, esophageal dilation. Clinical support services (out of 10) Surgical ICU, genetic testing/counseling, pediatric acute pain/sedation service, neonatal ICU, pediatric anesthesia program, pediatric infectious disease program, pediatric pain management program, pediatric ICU, rapid response team, infection control facilities. Committing to clinical research Degree of participation in specialty-specific research activities such as clinical trials and other bench-to-bedside research. Fellowship program Active training program in pediatric gastroenterology. Liver transplant program Reflects United Network for Organ Sharing-recognized liver transplant program and relative number of patients receiving liver transplants in the past 2 years. Nonsurgical procedure volume Reflects relative number of tests and noninvasive procedures. Specialized clinics and programs (out of 9) Examples: programs for intestinal rehabilitation, cystic fibrosis treatment, childhood obesity management, inflammatory bowel disease, chronic liver disease. Subspecialist availability (out of 8) Having certain specialists, surgeons, and other medical staff available for consultation and care, such as pediatric general surgeon and pediatric gastroenterologist. Survival after liver transplant Reflects patient survival three years following transplant. Neonatology Advanced clinical services (out of 5) Examples: Level 1 or 2 pediatric trauma center status as certified by American College of Surgeons or state licensing board, neonatal ICU-specific pharmacist who rounds with clinical team, NICU-designated nutritionist, social workers. Advanced technologies (out of 5) PET or PET/CT scanner, continuous EEG monitoring with pediatric neurology support, unsedated MRI, molecular diagnostic/virology laboratory, specialized chemistry laboratory with tandem mass spectroscopy. Clinical support services (out of 7) Genetic testing/counseling, pediatric acute pain/sedation service, pediatric anesthesia program, pediatric infectious disease program, pediatric pain management program, rapid response team, infection control facilities. Committing to best practices (out of 33) Examples: adhering to recommended maximum patient loads, standardized handoff tools, simulation/training laboratories for neonatal intensive care procedures, newborn cardiac patients receiving neonatology consults. Committing to clinical research (out of 4) Degree of participation in clinical trials and bench-to-bedside research. Examples: externally audited, national NICU treatment, quality-improvement research networks such as the Vermont Oxford Network and Extracorporeal Life Support Organization (ELSO) data exchange network. ECMO (heart-lung machine) 24-hour availability of heart-lung machine for newborns (extracorporeal membrane oxygenation), trained ECMO team. Fellowship programs (out of 15) Active training programs in pediatric neonatology. Examples: pediatric neurology, congenital cardiac surgery, neonatal-perinatal medicine, pediatric cardiology. Patient and family services (out of 17) The eight services listed in "Terms used across specialties," above, plus an additional nine. Examples: family support center, breast pumping rooms, lactation specialists, 24/7 parental visitation, sibling visitation, neonatal ICU-specific parent advisory committee, and NICU-specific parent-to-parent support groups. Specialized clinics and programs (out of 12) Examples: craniofacial team, spina bifida team, comprehensive retinopathy of prematurity program, neonatal-neuro intensive care program, NICU specific palliative care program, metabolic team, bowel rehabilitation team, home ventilator management team, and neuro-developmental follow-up clinic for high-risk NICU patients. Subspecialist availability (out of 15) Having certain specialists, surgeons, and other medical staff available for consultation and care, such as a pediatric head and neck surgeon, pediatric neonatologist, and critical care certified registered nurse. Nephrology Advanced clinical services (out of 8) Continuous renal replacement therapy; hemodialysis; peritoneal dialysis; UNOS-recognized kidney transplant program; maintenance dialysis staff that includes clinical nurses, social workers, and dietitians, and level 1 or 2 pediatric trauma center. Advanced technology PET or PET/CT scanning. Catheter procedure volume Relative number of catheter placements in past two years. Clinical support services (out of 9) Surgical ICU; pediatric acute pain/sedation service; neonatal ICU; pediatric anesthesia program; pediatric infectious disease program; pediatric pain management program; pediatric ICU; rapid response team; infection control facilities. Committing to best practices (out of 25) Examples: participation in regular interdisciplinary clinical conferences for urology/uroradiology and renal pathology to review and coordinate patient care, offering formal transition program for kidney transplant patients from pediatric to adult care, maintaining database of kidney transplant patients. Committing to clinical research Participation in specialty-specific research activities such as clinical trials and other bench-to-bedside research. Dialysis patients receiving transplants Reflects percentage of patients on maintenance dialysis who received kidney transplant within two years. Dialysis volume Relative number of patients in past two years who received regular dialysis. Fellowship program Active training program in pediatric nephrology. Kidney biopsy volume Relative number of kidney biopsies during past two years. Kidney transplant volume Relative number of transplants during past two years from deceased or living donors. Managing dialysis patients Reflects percentage of patients on dialysis in past two years with satisfactory lab tests. Patient and family services (out of 12) The eight services listed in "Terms used across specialties," above, and four additional services: programs to support patients in maintenance dialysis such as teachers dedicated to working with patients, standard review of patient's individualized education program, and/or summer camp. Preventing biopsy complications Reflects percentage of patients without complications after receiving kidney biopsy. Subspecialist availability (out of 8) Having certain specialists, surgeons, and other medical staff available for consultation and care, such as pediatric infectious disease specialist, pediatric anesthesiologist, and pediatric nephrologist. Success in preventing dialysis-related infections Success in minimizing dialysis-related infections. Survival after kidney transplant Reflects one- and three-year survival of patients and transplanted kidneys. Neurology & Neurosurgery Advanced clinical services (out of 18) Examples: pediatric headache clinic with psychologists specializing in headache biofeedback and preventive therapy, specialized epilepsy treatment center, sleep lab, neuroanesthesia program, neurological rehabilitation program. Advanced technologies (out of 7) Examples: PET or PET/CT scan, 3T MRI, neurophysiological intraoperative monitoring, magnetoencephalography. Clinical support services (out of 9) Surgical ICU, pediatric acute pain/sedation service, neonatal ICU, pediatric anesthesia program, pediatric infectious disease program, pediatric pain management program, pediatric ICU, rapid response team, reverse isolation/infection control facilities. Clinic volume Relative number of clinic patients in past year with certain disorders or who received certain specified care. Committing to best practices (out of 15) Examples: neuropsychological evaluations before and after surgery for benign and malignant brain tumors, maintaining a surgical mortality database, regular interdisciplinary care conferences. Committing to clinical research (out of 4) Participation in clinical trials and bench-to-bedside research. Additional credit for belonging to a national Phase 1 neuro-oncology clinical research consortium. Epilepsy management Relative success at treating children and infants with epilepsy. Epilepsy treatment volume Relative number of evaluations and procedures for epilepsy in past year. Fellowship programs (out of 2) Active training programs in pediatric neurology and neurosurgery. Preventing surgical complications Success in avoiding surgical complications and readmissions. Specialized clinics and programs (out of 15) Examples: clinics or programs for cerebrovascular accident, movement disorders, spina bifida, tuberous sclerosis, brachial plexus, and neonatal neurology. Subspecialist availability (out of 12) Having certain specialists, surgeons, and other medical staff available for consultation and care, such as pediatric neurosurgeon, pediatric neurologist, certified neuroscience nurse. Surgical survival Reflects relative number of deaths following surgery for selected neurological disorders such as brain tumors, head trauma, and medically untreatable epilepsy. Orthopedics Advanced clinical services (out of 6) Examples: comprehensive pediatric orthopedic program with dedicated pediatric imaging center, multidisciplinary musculoskeletal oncology program, motion laboratory. Advanced technologies (out of 3) PET/CT scanning, bone scan, remote retrieval of test results, images, and medical records. Clinical support services (out of 9) Surgical ICU; pediatric acute pain/sedation service; neonatal ICU; pediatric anesthesia program; pediatric infectious disease program; pediatric pain management program; pediatric ICU; rapid response team; infection control facilities. Committing to best practices (out of 15) Examples: having one or more active or candidate members of the Pediatric Orthopaedic Society of North America, pediatric imaging center with ultrasonographers having specialized training in hip exams, pediatric imaging center that minimizes radiation exposure, regular multidisciplinary morbidity and mortality conferences. Committing to clinical research Degree of participation in specialty-specific research activities such as clinical trials and other bench-to-bedside research. Fellowship program Active training program in pediatric orthopedics. Preventing surgical complications Reflects percentage of patients without complications following surgery for scoliosis, additional credit for low percentage of infections following spinal fusion surgery. Specialized clinics and programs (out of 8) Clinics or programs for brachial plexus, muscular dystrophy, neurofibromatosis, pain, skeletal dysplasia, spasticity, spina bifida, and sports medicine. Subspecialist availability (out of 16) Having certain specialists, surgeons, and other medical staff available for consultation and care, such as pediatric anesthesiologist, pediatric radiologists specializing in diagnostic and interventional radiology, pediatric orthopedic surgeon. Pulmonology Advanced clinical services (out of 11) Examples: respiratory therapists, certified asthma educators, gastroenterologist and endocrinologist who participate in patient care conferences, cystic fibrosis center accredited by Cystic Fibrosis Foundation, sleep center and sleep lab accredited by American Academy of Sleep Medicine. Advanced technology Availability of PET or PET/CT scanning. Asthma inpatient care Reflects care for asthma patients admitted to hospital based on mean length of stay, percentage of inpatient deaths attributable to asthma, percentage of inpatients readmitted within seven days of discharge for asthma-related symptoms. Asthma management Reflects percentage of patients following specific asthma management protocols. Clinical support services (out of 9) Surgical ICU, pediatric acute pain/sedation service, neonatal ICU, pediatric anesthesia program, pediatric infectious disease program, pediatric pain management program, pediatric ICU, rapid response team, infection control facilities. Committing to best practices (out of 14) Examples: consensus treatment and management plans for asthma exacerbations, bronchiolitis, croup, cystic fibrosis, pneumonia, and tracheostomy or ventilator-dependent patients. Committing to clinical research Degree of participation in specialty-specific research activities such as clinical trials and other bench-to-bedside research. Cystic fibrosis management Reflects success at managing lung function and nutritional status in cystic fibrosis patients. Fellowship program Active training program in pediatric pulmonology. Lung disease of prematurity management Reflects percentage of patients younger than 24 months of age receiving recommended care for this condition. Lung transplant program Reflects United Network for Organ Sharing recognition, number of transplants in past two years, and three-year survival rate. Neuromuscular weakness disorder management Reflects percentage of muscular dystrophy patients age 5 or older who had a lung function test in past year or within 90 days of undergoing general anesthesia. Preventing deaths of patients on ventilators Reflects success at preventing deaths of patients on ventilators as a result of accidental obstruction or other events. Subspecialist availability (out of 10) Having certain specialists, surgeons, and other medical staff available for consultation and care, such as pediatric radiologist, pediatric pulmonologist, pediatric sleep medicine physician. Urology Advanced clinical services (out of 8) Examples: shock wave lithotripsy, ureteroscopy, American College of Surgeons level 1 or 2 pediatric trauma center certification, laparoscopic variococelectomy and orchiopexy, and percutaneously nephrolithotripsy. Advanced technologies (out of 4) PET or PET/CT scan, onsite urodynamic equipment, video pediatric urodynamic fluoroscopy, surgical robot. Clinical support services (out of 9) Surgical ICU, pediatric acute pain/sedation service, neonatal ICU, pediatric anesthesia program, pediatric infectious disease program, pediatric pain management program, pediatric ICU, rapid response team, infection control facilities. Committing to best practices (out of 8) Examples: having a formal program for tracking surgical site infections for major urological procedures and regular mortality and morbidity conferences. Committing to clinical research (out of 3) Degree of participation in clinical trials and bench-to-bedside research. Additional credit for prospective randomized clinical trials, prospective observational studies, or prospective clinical databases on patient care. Fellowship program Active training program in pediatric urology. Minimally invasive procedure volume Relative number of patients in past year who had any of certain minimally invasive procedures such as shock wave lithotripsy, uteroscopy, and laparoscopic orchiopexy. Specialized clinics and programs (out of 6) Clinics or programs for spina bifida, voiding difficulties, kidney and urinary-tract stones, prenatal intervention, disorders of sexual differentiation, and genitourinary reconstructive surgery. Subspecialist availability (out of 12) Having certain specialists, surgeons, and other medical staff available for consultation and care, such as pediatric critical care specialist, pediatric urology surgeon, pediatric urologist. Success in preventing surgical complications Reflects relative success at avoiding surgical complications and readmissions. Complications and adverse events include pyeloplasty failure, orchiopexy failure, reoperation or readmission. Success in reducing urinary tract infections Success in preventing catheter-associated urinary tract infections (CAUTI).

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Best Children's Hospitals 2012-13: Guide to the Terms

President offers condolences following death of student Michael Curtis Augustin, a 33-year-old undergraduate died June 3 at Stanford University Hospital in Palo Alto, Calif. The cause of death is still being determined. (June 4, 2012)

Some stem cells can trigger tumors Adipose-derived stem cells often used in reconstructive surgeries including mastectomies can create a microenvironment suitable for more tumors to grow, researchers report. (June 4, 2012)

Analysis of maize shows genes involved in domestication Two new papers identify genes involved in domestication as well as variations and similarities between domesticated maize and its wild relatives. (June 4, 2012)

New book focuses on Frank Lloyd Wright's Freeman House Associate Professor Jeff Chusid's book 'Saving Wright: The Freeman House and the Preservation of Meaning, Materials, and Modernity' has won a prestigious award. (June 4, 2012)

Four faculty in Arts and Sciences honored The College of Arts and Sciences has awarded Appel fellowships to Lawrence McCrea and Nick Salvato, and Paul Academic Advising Awards to Alison Van Dyke and Dagmawi Woubshet. (June 4, 2012)

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Some stem cells can trigger tumors

Public release date: 4-Jun-2012 [ | E-mail | Share ]

Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Tampa, Fla. (June 4, 2012) After carrying out a study comparing the repopulation efficiency of immature hepatic stem/progenitor cells and mature hepatocytes transplanted into liver-injured rats, a research team from Sapporo, Japan concluded that mature hepatocytes offered better repopulation efficiency than stem/progenitor cells.

Until day 14 post-transplantation, the growth of the stem/progenitor cells was faster than the mature hepatocytes, but after two weeks most of the stem/progenitor cells had died. However, the mature hepatocytes continued to survive and proliferate one year after their implantation.

The study is published in Cell Transplantation (21:1), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.

"Cell-based therapies as an alternative to liver transplantation to treat liver disease have shown promise," said study corresponding author Dr. Toshihiro Mitaka of the Cancer Research Institute of the Sapporo Medical University School of Medicine, Sapporo, Japan. "However, the repopulation efficiency of two candidate cell sources - hepatic progenitor/stem cells and mature hepatocytes - had not been comprehensively assessed and questions concerning the efficiency of each needed to be resolved."

The researchers noted that the shortage of cell sources and the difficulties of cryopreservation have limited the clinical application of cell based therapies. Stem or progenitor cells have been considered candidate cells because they can expand in vitro and can be cryopreserved for a long time.

However, after transplantation into liver injured rats, the researchers found that stem/progenitor cells did not survive well and most of the transplanted cells had disappeared within two months. In contrast, the mature hepatocytes gradually repopulated the rat livers and continued doing so past one year.

The researchers noted that the sizes of the hepatocytes were not uniform.

"Unexpectedly, the small hepatocytes repopulated significantly less well than the larger ones," explained Dr. Mitaka. "We also found that serial transplantation did not enhance nor diminish the repopulation capacity of the cells to any significant degree."

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Mature liver cells may be better than stem cells for liver cell transplantation therapy

June 4, 2012

Some stem cells can trigger tumors, report scientists

Fischbach lab

Stem cells often used in reconstructive surgery following mastectomies and other cancer-removal treatments may pose a danger: Cornell biomedical scientists have discovered that these cells, in contact with even trace amounts of cancer cells, can create a microenvironment suitable for more tumors to grow.

"It is necessary for us not only to think about what happens with these cells in an otherwise healthy patient, but also, what the fate of stem cells may be in a patient who is prone to disease," said Claudia Fischbach-Teschl, assistant professor of biomedical engineering, who led the research published in Proceedings of the National Academy of Sciences, June 4.

The cells the researchers studied are derived from fat and are called adipose-derived stem cells. They are useful for tissue engineering and reconstructive surgery because they are good at taking over healthy tissue function and recruiting new blood vessels to promote healing.

But they might be too good -- that is, the Cornell researchers observed that the presence of cancer cell media -- the soluble material that contains chemicals secreted by tumor cells -- prevents the stem cells from turning into fat cells as would be desired. Instead, they triggered the cells to secrete chemicals known as "factors" that promote blood vessel growth, or angiogenesis, and to develop into myofibroblasts, which are cells known to play a role in tumor development.

These alterations led to a stiffening of the extracellular matrix that surrounds the cells -- the stiffening is a characteristic feature of breast cancer (which is why tumors can be palpated). Myofibroblasts make the surrounding tissue more rigid, and this stiffness triggers more changes in the stem cell behavior that lead to even more tumor-promoting characteristics -- a positive feedback loop.

The researchers observed these changes in in vitro experiments using stem cells and breast cancer cell lines that varied in aggression. First they collected soluble media from tumor cells and observed how the stem cells changed in response. They found that TGF-beta and interleukin-8 are specific tumor-secreted factors that contribute to the stem cells' eventual change in phenotype to myofibroblasts. They confirmed their results with in vivo experiments by injecting stem cells and tumor cells into the mammary glands of mice.

The experimental results are also supported by the fact that obese women are more likely to develop breast cancer. The presence of more adipose tissue means larger numbers of adipose stem cells, and one could hypothesize that the larger stem cell pool could promote tumor-progression processes, Fischbach-Teschl said.

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Some stem cells can trigger tumors, report scientists

PITTSBURGH (KDKA) Injecting stem cells into the brain of someone who has had a stroke is a hot button issue.

Is it safe? Can it be done?

Thats what researchers at the University of Pittsburgh are trying to find out.

Because these are cells that have not been injected into the brain before, we need to know whether it is safe to do so, UPMC neurologist Dr. Lawrence Wechsler said.

So far, at UPMC, two people have received injections of stem cells from the bone marrow of healthy adult donors.

Roger Hill is one of them.

In August 2009, he woke up with a stroke. The first thing he noticed was his vision. He couldnt see half of his world and then his left side left him.

Something happened with my left leg. I fell down, he said. I couldnt feel my left knee.

The problem was in the brain.

A stroke most commonly happens because of a blocked artery. Part of the brain dies from a lack of oxygen and blood flow. Stroke is a leading cause of death and disability.

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Researchers Testing Stem Cells As Treatment For Stroke Recovery

Public release date: 4-Jun-2012 [ | E-mail | Share ]

Contact: David Eve Celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Tampa, Fla. (June 4, 2012) When autologous (self-donated) lung-derived mensenchymal stem cells (LMSCs) were transplanted endoscopically into 13 adult female sheep modeled with emphysema, post-transplant evaluation showed evidence of tissue regeneration with increased blood perfusion and extra cellular matrix content. Researchers concluded that their approach could represent a practical alternative to conventional stem cell-based therapy for treating emphysema.

The study is published in Cell Transplantation (21:1), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/.

"Mensenchymal stem cells are considered for transplantation because they are readily available, highly proliferative and display multi-lineage potential," said study corresponding author Dr. Edward P. Ingenito of the Brigham and Women's Hospital Division of Pulmonary and Critical Care Medicine. "Although MSCs have been isolated from various adult tissues - including fat, liver and lung tissues - cells derived from bone marrow (BM) have therapeutic utility and may be useful in treating advanced lung diseases, such as emphysema."

However, according to the authors, previous transplantation studies, many of which used an intravenous delivery method, have shown that BM-MSCs have been only marginally successful in treating lung diseases. Further, therapeutic responses in those studies have been limited to animal models of inflammatory lung diseases, such as asthma and acute lung injury.

To try and answer the questions surrounding the utility of BM-MSCs for treating advanced emphysema, a disease characterized by tissue destruction and loss of lung structural integrity, for this study the researchers isolated highly proliferative, mensenchymal cells from adult lung parenchyma (functional tissue) (LMSCs) and used an endoscopic delivery system coupled with a scaffold comprised of natural extracellular matrix components.

"LMSCs display efficient retention in the lung when delivered endobronchially and have regenerative capacity through expression of basement membrane proteins and growth factors," explained Dr. Ingenito.

However, despite the use of autologous cells, only a fraction of the LMSCs delivered to the lungs alveolar compartment appeared to engraft. Cell death likely occurred because of the failure of LMSCs to home to and bind within their niche, perhaps because the niche was modified by inflammation or fibrosis. These cells are attachment-dependent and failure to attach results in cell death."

Their findings did suggest, however, that LMSCs were capable of contributing to lung remodeling leading to documented functional improvement rather than scarring 28 days post transplantation.

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Cell transplantation of lung stem cells has beneficial impact for emphysema

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

Formula Pharmaceuticals Inc., an oncology-focused biopharmaceutical company developing novel therapeutics that target both cancer stem cells (CSCs) and various minimal residual disease settings, announced today the appointment of Morton Collins to its Board of Directors.

Mr. Collins brings decades of experience in corporate financing and leadership within life science companies, said Maurits W. Geerlings, Chief Executive Officer of Formula Pharmaceuticals. We are honored to welcome Mr. Collins to our Board of Directors, at a time when our company is transitioning into a multinational business.

Earlier in his career, Mr. Collins was the Founder and Chief Executive Officer of Data Science Ventures, Inc. (DSV I). He was a Founder of DSV Associates (DSV II); DSV Partners III (DSV III); DSV Partners IV (DSV IV) and has been the Managing Partner of each entity. These organizations provide venture capital and management assistance to early-stage high-technology companies. In 1997, Mr. Collins became a Special Limited Partner of Cardinal Partners, the successor to the DSV series of partnerships. In 2003, Mr. Collins became a General Partner of Battelle Ventures which he founded. Mr. Collins has served as a Director at Alkermes, Apollon Inc. and The Liposome Company, three successful life science companies.

By preventing the recurrence of cancer, Formulas vaccine has the potential to significantly impact survival outcome in a variety of tumor indications. I look forward to working with the Board to fully leverage Formulas important mission to develop innovative, life-saving cancer therapies for patients, said Mr. Collins.

In addition to his leadership in numerous life science and technology ventures, Mr. Collins has served on the New Jersey Governors Commission on Science and Technology and the New Jersey Governors Superconductivity Roundtable. During the Reagan Administration, he chaired the Presidents Task Force on Innovation and Entrepreneurship and served as a technology policy advisor to President George H.W. Bush. Mr. Collins earned his B.S. from the University of Delaware and his Masters and Doctorate Degrees from Princeton University. He remains an active alumnus at both institutions.

About Formula Pharmaceuticals

Formula Pharmaceuticals, Inc. is a privately-held, oncology drug development company advancing novel medicines to address areas of unmet therapeutic need in cancer. Formulas lead product candidate, FPI-01 is a first-in-class immunotherapeutic in clinical development for the maintenance of first-remission in acute myeloid leukemia (AML) and other cancers. Building upon deep industry expertise in developing novel medical approaches, Formulas focus is on accelerating future life-saving cancer therapies.

Founded in late 2009 by Dr. Geerlings and Dr. Mosconi, Formula has assembled a world-class scientific, clinical development and business team well positioned to maximize the clinical and commercial value of promising drug candidates through excellence in drug development and strategic partnering. For more information, visit http://www.formulapharma.com.

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Formula Pharmaceuticals Appoints Morton Collins to Board of Directors

SOUTHAMPTON, England, June 3 (UPI) -- British physicians say some patients with osteonecrosis who need hip replacements could be treated with stem cells from their own bone marrow.

The procedure, developed by Doug Dunlop of Southampton General Hospital in England, involves mixing the stem cells with cleaned, crushed bone from another patient who has had his own hip replaced and using it to fill the hole made after damaged tissue removed from the joint, The Daily Telegraph reported.

The new stem cell therapy could prevent the need for hip replacements due to osteonecrosis, a condition where poor blood supply causes significant bone damage leading to severe arthritis, Dunlop said.

The stem cells send chemical signals to blood vessels and it's hoped the new vessels in the hip would supply nutrients to improve bone strength, Dunlop explained.

Oesteoarthrits, caused by wear and tear of the bone, results from the temporary or permanent loss of blood flow to bones.

This causes osteonecrosis -- or the bones to "die" -- and ultimately severe arthritis, but if osteonecrosis occurs at the bone joint, it can cause it to collapse and the only option is a hip replacement, Dunlop said.

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Stem cells may preclude hip replacements

EXTON, Pa., June 4, 2012 /PRNewswire/ -- ViroPharma Incorporated (VPHM) today announced the initiation of a Phase 2 program to evaluate maribavir for the treatment of cytomegalovirus infections in transplant recipients. The planned program will consist of two independent Phase 2 clinical studies that will include subjects at different ends of the spectrum of CMV infection or disease, namely those who have asymptomatic CMV, and those who have failed therapy with other anti-CMV agents. Maribavir was granted U.S. Orphan Drug Designation in May of 2011 for treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.

In addition, an abstract of data collected through the use of maribavir at six French transplant centers as part of a named patient program (NPP) has been accepted for the 24th International Congress of the Transplantation Society to be held on July 15th through 19th in Berlin, Germany.

"Physicians continue to see potential value in the novel mechanism of action of maribavir when used at higher doses in critically ill patients, particularly when other options have failed," stated Marc E. Uknis, MD, medical director, ViroPharma Incorporated. "The outcomes seen in a small number of the NPP patients and the previously published experience in emergency-use IND patients suggests the possibility that maribavir may provide meaningful antiviral effects in treating active CMV infection and merits further careful evaluation because of the serious unmet need in immunocompromised transplant patients."

"Asymptomatic" CMV Study ViroPharma has initiated a randomized, dose blinded multicenter Phase 2 study intended to enroll up to 160 subjects (recipients of either hematopoietic stem cell or solid organ transplant) who have demonstrated CMV viremia but do not have CMV organ disease. Further, these subjects cannot have CMV infection that is resistant to other anti-CMV agents. Subjects will be randomized to receive oral maribavir at one of three doses (400mg, 800mg or 1200mg BID) or valganciclovir for up to 12 weeks. Blood levels of CMV DNA will be monitored throughout the study, and minimum virologic responses will be required after 3 and 6 weeks of treatment to continue study drug. The study will be conducted at multiple transplant centers in 3-4 countries in Europe.

Resistant/Refractory CMV Study ViroPharma is planning to initiate a second study, a randomized, dose blinded multicenter Phase 2 study intended to enroll up to 120 subjects (recipients of either hematopoietic stem cell or solid organ transplant) who have demonstrated CMV viremia with or without CMV organ disease. All subjects will have failed to have an adequate virologic response to prior treatment with ganciclovir, valganciclovir, or foscarnet, and may have documented viral genetic resistance to any of these anti-CMV agents. Subjects will be randomized to receive oral maribavir at one of three doses (400mg, 800mg or 1200mg BID) for up to 24 weeks. Blood levels of CMV DNA will be monitored throughout the study, and minimum virologic responses will be required after 3 and 6 weeks of treatment to continue study drug. The study is planned to be conducted at multiple transplant centers in the United States.

About Maribavir Maribavir, a member of a new class of drugs called benzimidazole ribosides, is a potent and selective, orally bioavailable antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable clinical safety profile. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, maribavir inhibits viral DNA assembly and inhibits egress of viral capsids from the nucleus of infected cells. Maribavir is active in vitro against strains of CMV that are resistant to commonly used anti-CMV drugs. The previous focus of clinical development of maribavir as an anti-CMV agent was on the prevention of CMV disease in transplant patients. Results from Phase 3 studies indicated that maribavir at a dose of 100mg BID failed to meet its efficacy endpoints; however, maribavir has demonstrated a favorable safety and tolerability profile in all clinical studies to date. While Phase 3 studies of CMV prophylaxis at the 100mg BID dose did not show sufficient activity to prevent CMV disease, the overall safety profile of maribavir and limited data from cases in which open-label maribavir was used as CMV treatment suggest that higher doses may provide clinical activity. The U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to maribavir in May of 2011 for treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients.

About Cytomegalovirus CMV is a memberof the herpesvirus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores), and herpes genitalis (genital herpes). Like other herpesviruses, CMV has the ability to remain dormant in the body for long periods of time. Human CMV infection rates average between 50 percent and 85 percent of adults in the U.S. by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals including cancer patients, HIV patients, and transplant patients, and in children born with primary CMV infection, CMV can lead to serious disease or death. Patients who are immunosuppressed following hematopoietic stem cell (bone marrow) or solid organ transplantation are at high risk of CMV infection. In these patients, CMV can lead to severe conditions such as pneumonitis or hepatitis, or to complications such as acute or chronic rejection of a transplanted organ. While currently available systemic anti-CMV agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment.

About ViroPharma Incorporated ViroPharma Incorporated is an international biopharmaceutical company committed to developing and commercializing novel solutions for physician specialists to address unmet medical needs of patients living with diseases that have few if any clinical therapeutic options. ViroPharma is developing a portfolio of therapeutics for rare and Orphan diseases including C1 esterase inhibitor deficiency, Friedreich's Ataxia, and adrenal insufficiency, cytomegalovirus (CMV); and recurrent C. difficile infection (CDI). Our goal is to provide rewarding careers to employees, to create new standards of care in the way serious diseases are treated, and to build international partnerships with the patients, advocates, and health care professionals we serve. ViroPharma's commercial products address diseases including hereditary angioedema (HAE), seizures, adrenal insufficiency and C. difficile-associated diarrhea (CDAD); for full U.S. prescribing information on our products, please download the package inserts at http://www.viropharma.com/Products.aspx; the prescribing information for other countries can be found at http://www.viropharma.com.

ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company's web site, http://www.viropharma.com. The company encourages investors to consult these sections for more information on ViroPharma and our business.

Forward Looking Statements Certain statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events, including the therapeutic indication and use, safety, efficacy, tolerability and potential of maribavir and our focus, goals, strategy, research and development programs, and ability to develop pharmaceutical products, commercialize pharmaceutical products, and execute on our plans including clinical development activities with maribavir related to treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease. In February 2009, based upon preliminary analysis of the data, we announced that our Phase 3 trial evaluating maribavir used as prophylaxis in allogeneic stem cell, or bone marrow, transplant patients did not achieve its primary endpoints. In addition, the study failed to meet its key secondary endpoints. Additionally, we announced that our Phase 3 trial evaluating maribavir in liver transplant patients was discontinued and that all patients on study drug were moved to current standard of care. While the current studies are in different patient populations and utilize different dosing levels, there can be no assurance that our clinical program with maribavir for the treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease will yield positive results or support further development of maribavir for either indication. The preliminary results from a small number of NPP and emergency-use IND patients may not be predictive of the results of the studies described in this press release. The FDA or EMA may view the data regarding maribavir for the treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease as insufficient or inconclusive, request additional data, require additional clinical studies, delay any decision past the time frames anticipated by us, limit any approved indications, or deny the approval of maribavir for the treatment of subjects with asymptomatic CMV as well as resistant / refractory CMV disease.

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ViroPharma Announces Initiation of Clinical Studies to Evaluate Maribavir for Treatment of Cytomegalovirus (CMV ...

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Stem cells tested for heart attack repair

SAN DIEGO, CA--(Marketwire -06/04/12)- Medistem Inc. (MEDS) announced today positive safety data from the first 5 patients enrolled in the Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC) trial. The clinical trial uses the company's "Universal Donor" Endometrial Regenerative Cells (ERC) to treat Congestive Heart Failure (CHF).

According to the study design, after 5 patients enter the trial, they must be observed for a two month time period before additional patients are allowed to enter the study. Patient data was analyzed by the study's independent Data Safety Monitoring Board (DSMB), which concluded that based on lack of adverse effects, the study be allowed to continue recruitment.

"Medistem is developing a treatment for CHF that uses a 30-minute catheter-based procedure to administer the ERC stem cell into the patients' hearts. The achievement of 2 month patient follow-up with no adverse events is a strong signal for us that our new approach to this terrible condition is feasible," said Thomas Ichim, CEO of Medistem.

The RECOVER-ERC trial will treat a total of 60 patients with end-stage heart failure with three concentrations of ERC stem cells or placebo. The clinical trial is being conducted by Dr. Leo Bockeria, Chairman of the Backulev Centre for Cardiovascular Surgery, in collaboration with Dr. Amit Patel, Director of Clinical Regenerative Medicine at University of Utah.

"As a professional drug developer, I am very optimistic of a stem cell product that can be used as a drug. The ERC stem cell can be stored frozen indefinitely, does not need matching with donors, and can be injected in a simple 30-minute procedure into the heart," said Dr. Sergey Sablin, Vice President of Medistem and co-founder of the multi-billion dollar NASDAQ company Medivation.

Currently patients with end-stage heart failure, such as the ones enrolled in the RECOVER-ERC study, have no option except for heart transplantation, which is limited by side effects and lack of donors. In contrast to other stem cells, ERC can be manufactured inexpensively, do not require tissue matching, and can be administered in a minimally-invasive manner. Animal experiments suggest ERC are more potent than other stem cell sources at restoring heart function. The FDA has approved a clinical trial of ERC in treatment of critical limb ischemia in the USA.

About Medistem Inc. Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.

Cautionary Statement This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

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Medistem Achieves Important ERC Stem Cell Clinical Trial Milestone

CHICAGO--(BUSINESS WIRE)--

OncoMed Pharmaceuticals, Inc., a privately held, clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor initiating cells, today highlighted new data presented this afternoon in a poster discussion session at the Annual Meeting of the American Society for Clinical Oncology (ASCO) in Chicago, IL. This represents the first clinical presentation of OMP-59R5, a monoclonal antibody targeting the Notch2 and Notch3 receptors. Authors of the poster, A First-in-Human Phase I Study to Evaluate the Fully Human Monoclonal Antibody OMP-59R5 (anti-Notch2/3) Administered Intravenously to Patients with Advanced Solid Tumors, concluded that OMP-59R5 was generally well tolerated and established maximum tolerated doses (MTDs) of 2.5mg/kg weekly (QW) and 5mg/kg every other week (QoW) for the drug.

The study results were presented by Dr. Anthony Tolcher of The START Center for Cancer Care, San Antonio, TX. Dr. Tolcher noted that the main treatment-related adverse event was diarrhea and there was evidence of Notch pathway modulation with this drug. Dr. David Smith and colleagues at the University of Michigan Cancer Center at Ann Arbor, MI also participated in the Phase I study. The anti-Notch2/3 program is part of OncoMeds collaboration with GlaxoSmithKline.

The Phase I dose-escalation study (3+3 design) was initiated in patients with advanced solid tumors. The investigational antibody, OMP-59R5, was administered to study safety, pharmacokinetics (PK), pharmacodynamics (PD), preliminary efficacy, and to determine the MTD. Thirty patients have been enrolled in four dose-escalation cohorts at doses of 0.5, 1, 2.5, and 5mg/kg administered weekly, as well as two dose-escalation cohorts of 5 and 10mg/kg administered every other week. The study is ongoing and will test an every-three-week dosing schedule.

The most frequently reported drug-related adverse events were: mild to moderate diarrhea, fatigue, nausea, vomiting, decreased appetite, and constipation. Diarrhea was dose related and occurred at doses 2.5mg/kg weekly and appeared less pronounced with every-other-week dosing. The PK of OMP-59R5 was characterized by rapid, dose-dependent clearance. Several patients had prolonged stable disease for 56 days (tumor types included Kaposis Sarcoma, adenoid cystic carcinoma, rectal cancer, and liposarcoma). PD modulation of Notch pathway was detectable in surrogate tissue and in tumor and occurred at doses 1mg/kg. The OMP-59R5 clinical program is advancing toward PhIb/II development in solid tumor indications.

About Anti-Notch2/3

The Notch pathway plays a central role in embryonic development, the regulation of stem and progenitor cells, and is implicated centrally in many human cancers. OMP-59R5 is a fully human IgG2 monoclonal antibody originally identified by binding to Notch2. It inhibits the signaling of both Notch2 and Notch3 receptors. Mouse xenograft studies using minimally-passaged, patient-derived xenografts have shown that OMP-59R5 impedes tumor growth and eliminates CSCs in many tumor types. OMP-59R5 modulates the expression of stromal genes and genes associated with the function of tumor vascular pericytes. Based on preclinical experiments, we believe that OMP-59R5 is a novel anti-cancer agent that inhibits tumor growth through direct actions on tumor cells, including CSCs, and effects on the stroma and vasculature.

About Cancer Stem Cells

Cancer stem cells, a small, resilient subset of cells found in tumors, have the capacity to self-renew and differentiate, leading to tumor initiation and driving tumor growth, recurrence and metastasis. Also referred to as tumor-initiating cells, these cells were first discovered by OncoMeds scientific founders in breast cancer and have subsequently been identified in many other tumor types, including brain, colon, lung, prostate, and pancreatic cancer. Cancer stem cells appear to be preferentially resistant to both standard chemotherapy and radiotherapy. OncoMeds strategy is to improve cancer treatment by specifically targeting the key biologic pathways that are thought to be critical to the activity and survival of cancer stem cells. OncoMeds antibody therapeutics target cancer stem cell proteins and have the potential to be developed against a range of tumor types.

About OncoMed Pharmaceuticals

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OncoMed Presents First-in-Human Phase I Data on Anti-Notch2/3 Antibody at ASCO

Hyderabad, June 2:

Picking stem cells from a patients body, sending it to a sophisticated laboratory to culture a tissue and then implanting it are pass.

A team of doctors at L.V. Prasad Eye Institute has used the tea bag or sprinkler approach to regenerate stem cells. The organisation has developed a lab-free technique that could be available off-the-shelf. This allows eye surgeons with usual facilities to perform the procedure.

The team, led by Dr Virender Singh Sangwan, used this technique to treat those who suffered chemical injuries, resulting in bleeding in the cornea.

Instead of sending stem cells to the lab for culture, the doctor picked the required number of stem cells around the cornea and sprinkled on the damaged area and then put a contact lens. In 15 days, he sees development of a good layer in the place of injured area, Prof. Balasubramanian, Head of Research at LVPEI, said.

A winner of the prestigious Shanti Swarup Bhatnagar prize, Dr Sangwan said he had conducted the procedure on about 25 patients with good results. This had been published in international scientific magazines.

He is now in the process of developing tools to help doctors.

Leber Congenital Amaurosis

Children down with the rare ocular disorders that result in gradual loss of sight can hope for a cure. Doctors are working on a gene therapy to correct this problem caused by consanguineous marriages.

Though this therapy is in vogue abroad, LVPEI says it is the first centre to carry out research on this procedure. Technically called LCA or Leber Congenital Amaurosis, doctors would refer patients to a gene analysis after studying them for indications.

Read more here:
Stem cell therapy for cornea treatment

Hyderabad, June 2:

Picking stem cells from a patients body, sending it to a sophisticated laboratory to culture a tissue and then implanting it are pass.

A team of doctors at L.V. Prasad Eye Institute has used the tea bag or sprinkler approach to regenerate stem cells. The organisation has developed a lab-free technique that could be available off-the-shelf. This allows eye surgeons with usual facilities to perform the procedure.

The team, led by Dr Virender Singh Sangwan, used this technique to treat those who suffered chemical injuries, resulting in bleeding in the cornea.

Instead of sending stem cells to the lab for culture, the doctor picked the required number of stem cells around the cornea and sprinkled on the damaged area and then put a contact lens. In 15 days, he sees development of a good layer in the place of injured area, Prof. Balasubramanian, Head of Research at LVPEI, said.

A winner of the prestigious Shanti Swarup Bhatnagar prize, Dr Sangwan said he had conducted the procedure on about 25 patients with good results. This had been published in international scientific magazines.

He is now in the process of developing tools to help doctors.

Leber Congenital Amaurosis

Children down with the rare ocular disorders that result in gradual loss of sight can hope for a cure. Doctors are working on a gene therapy to correct this problem caused by consanguineous marriages.

Though this therapy is in vogue abroad, LVPEI says it is the first centre to carry out research on this procedure. Technically called LCA or Leber Congenital Amaurosis, doctors would refer patients to a gene analysis after studying them for indications.

Read more from the original source:
Stem cell therapy for cornea treatment

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.

The rest is here:
Biostem U.S., Corporation Presents Scientific and Medical Board of Advisors Publications

Stem cell therapy may one day be used to cure disorders such as Fragile-X syndrome, or Cystic fibrosis and other genetic maladies.

Matthew Vella

The Maltese government wants the European Commission to abandon plans to provide funds for research activities on stem cells that involve "the destruction of human embryos".

In a declaration on the ethical principles for the Horizon 2020 programme, which is an 80 billion fund for the EU's programme for research and innovation to create new jobs, the Maltese government said it wanted more detailed guidelines on the bioethical principles that will guide research programmes.

Horizon 2020 will allow the financing of research on human stem cells - both adult and embryonic - as long as it is permitted by the national laws of member states.

The fund however will not finance human cloning, genetic modification, or the creation of human embryos intended for the purpose of research or stem cell procurement.

The European Commission does not explicitly solicit the use of human embryonic stem cells, but Horizon 2020 allows the use of human stem cells according to the objectives of the research, and only if it has the necessary approvals from the member states.

The Maltese declaration echoes previous statements by the Commission of Catholic Bishops of the EC (Comece), which said Horizon 2020 did not include greater protection of human embryos from stem cell research.

Malta says it does not want any such embryos to be used for stem cell research. The statement by the Maltese government said the Horizon 2020 programme "does not take sufficiently into account the therapeutic potential of human adult stem cells."

Malta wants Europe to commit to a reinforcement of research on human adult stem cells, and that Europe should abstain from financing matters of fundamental ethical principles, which differ among member states.

Originally posted here:
Malta opposing EU financing for stem cell research on embryos

Stem cells provided by San Diego-based Stemedica Cell Technologies Inc. are expected to be used soon in a phase I/II clinical trial for chronic heart failure in Mexico.

Stemedica announced May 29 that its strategic Mexico partner, Grupo Angeles Health Services, has received approval for a single-blind randomized clinical trial from Mexicos FDA equivalent regulatory agency, COFEPRIS.

The trial being conducted at multiple hospital sites throughout Mexico will involve Stemedicas adult allogeneic ischemia tolerant mesenchymal stem cells delivered via intravenous infusion. The trial will involve three safety cohorts at different dosages, followed by a larger group being treated with the maximum safe dosage.

The trial, set to begin on or before July 1 with 60 to 80 patients, is one of only two studies using allogeneic stem cells approved by COFEPRIS. The other study approved in 2010 was a clinical trial for ischemic stroke.

We are pleased that we will be working with the largest and most prestigious private medical institution in Mexico to study Stemedicas product for this indication, said Stemedica CEO Maynard Howe in a statement. If successful, our stem cells may provide a treatment option for the millions of patients, both in Mexico and internationally, who suffer from this condition.

Grupo Angeles, comprised of 24 state-of-the-art hospitals, conducts some 100 clinical trials annually, primarily with major global pharmaceutical and medical device companies.

Stemedica stem cells are also currently being used in a phase I/IIa trial for stroke patients at UC San Diego. The 36-patient clinical trial has been progressing about a year and is moving into its third and final cohort, said Dave McGuigan, vice president of marketing and business development for the company. When patient treatments are completed by the end of September, data will be evaluated to determine whether it moves to a full phase IIb trial to primarily determine efficacy in a larger population of 60 to 80 patients, McGuigan said.

Our next step would be to initiate a phase II clinical trial in multiple sites across the U.S. in 2013, he said.

Founded seven years ago, the privately held Stemedica specialty biopharmaceutical company has about 46 locally based employees in the U.S. and an additional eight staff in Switzerland, South Korea and Singapore.

View post:
Stemedica Takes Part in Mexican Clinical Trial

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.

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

Stem cell therapy may one day be used to cure disorders such as Fragile-X syndrome, or Cystic fibrosis and other genetic maladies.

Matthew Vella

The Maltese government wants the European Commission to abandon plans to provide funds for research activities on stem cells that involve "the destruction of human embryos".

In a declaration on the ethical principles for the Horizon 2020 programme, which is an 80 billion fund for the EU's programme for research and innovation to create new jobs, the Maltese government said it wanted more detailed guidelines on the bioethical principles that will guide research programmes.

Horizon 2020 will allow the financing of research on human stem cells - both adult and embryonic - as long as it is permitted by the national laws of member states.

The fund however will not finance human cloning, genetic modification, or the creation of human embryos intended for the purpose of research or stem cell procurement.

The European Commission does not explicitly solicit the use of human embryonic stem cells, but Horizon 2020 allows the use of human stem cells according to the objectives of the research, and only if it has the necessary approvals from the member states.

The Maltese declaration echoes previous statements by the Commission of Catholic Bishops of the EC (Comece), which said Horizon 2020 did not include greater protection of human embryos from stem cell research.

Malta says it does not want any such embryos to be used for stem cell research. The statement by the Maltese government said the Horizon 2020 programme "does not take sufficiently into account the therapeutic potential of human adult stem cells."

Malta wants Europe to commit to a reinforcement of research on human adult stem cells, and that Europe should abstain from financing matters of fundamental ethical principles, which differ among member states.

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Malta opposing EU financing for stem cell research on embryos